Diabetic Foot Ulcer, Leg Ulcer, Pressure Ulcer
Conditions
Keywords
Diabetic Foot Ulcer, Pressure Ulcer, Leg Ulcer
Brief summary
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
Detailed description
The study is a pilot RCT, which will generate the first comparative clinical, economic, and safety data for use of ALNB in subjects. A small sample of subjects with a range of chronic, moderate to highly exuding ulcer types (LU \[arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy\], PU, and non-ischemic DFU) will be enrolled and followed for 12 weeks to study the impact on health-related quality of life, ulcer progression and healthcare resource utilization.
Interventions
DEVICEALLEVYN Life Non-Bordered
Foam Dressing
DEVICEStandard Care
Foam Dressing
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject must provide informed consent to participate in the study. 2. The subject must be eighteen (18) years of age or older. 3. The subject must be willing and able to make all required study visits. 4. The subject must be able to follow instructions and be deemed capable of completing the CWIS questionnaire. 5. The subject must present with a chronic (≥ 4 weeks duration) ulcer which meets all of the following criteria: 1. The ulcer is classified as either: * a pressure ulcer * a non-ischemic diabetic foot ulcer * a leg ulcer (arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy) 2. The ulcer is, in the opinion of the Investigator, moderate to highly exuding. 3. The ulcer would, in the opinion of the Investigator, benefit from a protective dressing. 4. The ulcer is not infected based on clinical signs/symptoms. 6. A subject with a DFU must have an ankle-brachial index (ABI) of 0.7 or greater, as measured within 30 days of the Screening Visit.
Exclusion criteria
1. Contraindications or hypersensitivity to the use of the ALLEVYN LIFE Non-Bordered, comparator, ancillary products, or their components. 2. Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study. 3. The subject's reference ulcer is being treated with a topical antimicrobial dressing. 4. Subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments. 5. Subjects who have participated previously in this clinical trial. 6. Subjects with a history of poor compliance with medical treatment. 7. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | Baseline through 6 weeks | The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period. The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern. The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used: CWIS-PSDL = (Sum of PSDL item scores-N\_PSDL)/(N\_PSDL x 4) ×100, where NPSDL = count of 24 questions completed (experience and stress) PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale \[1-5\]) with higher scores indicating a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Baseline, Weeks 3, 6, and 12 | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) for an overall wound score at each time point. The mBWAT score combined the sub-scores of mBWAT - a tool that has been in widespread use since the early 1990s. mBWAT scoring: There are 13 categories of assessment with item-level score range of 1 to 5 on a modified Likert scale. Each item is scored for the wound characteristic it describes where 1 indicates least severe and 5 indicates most severe with higher scores indicating a more severe wound status. Scores taken over a period of time can be used to track the progression of the wound healing process. Possible score range from 13 to 65 for the total score. The 13 sub-categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization |
| Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline, Weeks 3, 6, and 12 | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the type of wound exudate exhibited at each time point. The tool defines the types of exudate as follows: Bloody = thin, bright red Serosanguinous = thin, watery, pale red to pink Serous = thin, watery, clear Purulent = thin or thick, opaque tan to yellow Foul purulent = thick, opaque yellow to green with offensive odor |
| Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline, Weeks 3, 6, and 12 | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of wound exudate demonstrated at each time point. The tool gives the following category descriptions for amount of exudate: None = wound tissues dry Scant = wound tissues moist; no measurable exudate Small = wound tissues wet; moisture evenly distributed in wound; drainage involves \</=25% dressing Moderate = wound tissues saturated; drainage may or may not be evenly distributed in wound; drainage involves \>25% to \</=75% dressing Large = wound tissues bathed in fluid; drainage freely expressed; may or may not be evenly distributed in wound; drainage involves \>75% dressing The tool advises to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to determine percentage of dressing involved with exudate. |
| Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change | Baseline through 12 weeks | Analysis of the healthcare resources used related to the reference ulcer included: Type of primary and secondary dressings including compression therapy used during each dressing change over the 12-week treatment period based on the size of the ulcer. |
| Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline, Weeks 3, 6, and 12 | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the extent (measurement) of wound undermining at each time point. The tool guidance is as follows: Assess by inserting a cotton-tipped applicator under the wound edge; Advance it as far as it will go without using undue force; Raise the tip of the applicator so it may be seen or felt on the surface of the skin; Mark the surface with a pen; Measure the distance from the mark on the skin to the edge of the wound; Continue process around the wound; Then use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved. |
| Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline, Weeks 3, 6, and 12 | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for type (appearance) of necrotic tissue at each time point. The tool defines the categories of necrotic tissue type as follows: White/gray non-viable tissue = may appear prior to wound opening; skin surface is white or gray Non-adherent, yellow slough = thin, mucinous substance; scattered throughout wound bed; easily separated from wound tissue Loosely adherent, yellow slough = thick, stringy, clumps of debris; attached to wound tissue Adherent, soft, black eschar = soggy tissue; strongly attached to tissue in center or base of wound Firmly adherent, hard/black eschar = firm, crusty tissue; strongly attached to wound base and edges (like a hard scab) |
| Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline, Weeks 3, 6, and 12 | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of necrotic tissue observed during dressing change at each time point. The tool guidance is to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to help determine percent of wound involved. |
| Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline, Weeks 3, 6, and 12 | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance of skin color changes surrounding the reference wound at each time point. The tool guidance is to assess tissues within 4 cm of wound edge. Dark-skinned persons show the colors bright red and dark red as a deepening of normal ethnic skin color or a purple hue. As healing occurs in dark-skinned persons, the new skin is pink and may never darken. |
| Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline, Weeks 3, 6, and 12 | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance and percentage of granulation tissue in the reference wound at each time point. Granulation tissue is the growth of small blood vessels and connective tissue to fill in full-thickness wounds. Tissue is healthy when bright, beefy red, shiny, and granular with a velvety appearance. Poor vascular supply appears as pale-pink or blanched to dull, dusky red color. |
| Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline, Weeks 3, 6, and 12 | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the percentage of reference wound demonstrating epithelialization at each time point. Epithelialization is the process of epidermal resurfacing and appears as pink or red skin. In partial-thickness wounds, it can occur throughout the wound bed as well as from the wound edges. In full-thickness wounds, it occurs from the edges only. Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved and to measure the distance the epithelial tissue extends into the wound. The mBWAT 13 categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization. |
| Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks | Assessment of the change over time for the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Score at 3 and 12 weeks; CWIS-Well-Being (WB), CWIS-Social Life (SL), CWIS-Global Quality of Life (GQ), CWIS-Quality of Life Scales (SQ) at 3, 6, and 12 weeks. PSDL, SL, and WB sub-scores are based on 24 (score range 24-120), 14 (score range 14-70), and 7 (score range 7-35) questions, respectively; (each graded on a 5-point Likert scale \[1-5\]) Higher scores on all CWIS metrics indicate a better outcome. PSDL score = (sum of PSDL item scores - 24)/96 x 100 = calculated score of 0 to 100; e.g., 95-24/96 x 100 = 74 (of a possible 100) WB Score = (sum of WB item scores - 7)/28 x 100 = calculated score of 0 to 100 SL Score = (sum of SL item scores - 14)/56 x 100 = calculated score of 0 to 100 GQ Score = How good is your quality of life = score range 0 to 10 SQ Score = How satisfied are you with your overall quality of life = score range 0 to 10 |
| Ulcer Progression Assessed by Change From Baseline in Wound Area | Baseline, Weeks 3, 6 and 12 | The change from Baseline of the wound area was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound area measurements. |
| Ulcer Progression Assessed by Change From Baseline in Wound Volume | Baseline, Weeks 3, 6, and 12 | The change from Baseline of the wound volume was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound volume measurements. |
| Ulcer Progression Assessed by Change From Baseline in Wound Depth | Baseline, Weeks 3, 6, and 12 | The change from Baseline in the wound depth was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound depth measurements. |
| Number of Participants With Reference Wound Healed | Weeks 3, 6 and 12 | Assessment of the wound healed status (100% re-epithelialized, no drainage, no need for dressing) was analyzed at each visit to determine the healing status of the ulcer. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. |
| Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used | Baseline through 12 weeks | Analysis of the healthcare resources used related to the reference ulcer included: Number of primary and secondary dressings including use of compression therapy. |
| Healthcare Resource Use - Number and Type of Compression Dressings Used | Baseline through 12 weeks | Not all enrolled participants required the use of compression dressings. Of those participants who did require a compression dressing, an analysis of the healthcare resources used included the number and type of primary and secondary dressings used in relation to the reference ulcer. |
| Healthcare Resource Use - Number of Participants Requiring Hospital Admission | Baseline through 12 weeks | Analysis of the healthcare resources used for participants who required a hospital admission related to the reference ulcer. |
| Healthcare Resource Use - Number of Days Participants Required In-Hospital Care | Baseline through 12 weeks | Analysis of the healthcare resources used related to the reference ulcer included: Time in hospital (number of days spent as an inpatient due to reference ulcer). |
| Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Baseline through 12 weeks | Analysis of the healthcare resources used related to the reference ulcer included: Interventions/procedures related to the reference ulcer (number and type) including debridement of the ulcer. |
| Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline, Weeks 3, 6, and 12 | Evaluation of the number of participants demonstrating peri-wound changes in appearance as determined visually by the Investigator; categorized as normal, erythematous, edematous, eczematous, excoriated, macerated, or indurated at each time point. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALLEVYN Life Non-Bordered Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing | 25 |
| Standard Care Standard care dressing
Standard Care: Foam Dressing | 15 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Noncompliance | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Reference ulcer healed | 1 | 0 |
| Overall Study | Surgeon applied a graft with non-removable dressing; discharged to surgeon's care | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Standard Care | Total | ALLEVYN Life Non-Bordered |
|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 16.8 | 57.5 years STANDARD_DEVIATION 16.1 | 59.8 years STANDARD_DEVIATION 15.5 |
| Body Mass Index | 34.1 kg/m^2 STANDARD_DEVIATION 5.7 | 31.3 kg/m^2 STANDARD_DEVIATION 8.4 | 29.6 kg/m^2 STANDARD_DEVIATION 9.4 |
| Height | 69.0 inches STANDARD_DEVIATION 4.1 | 68.3 inches STANDARD_DEVIATION 3.7 | 67.9 inches STANDARD_DEVIATION 3.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Reference Wound Type Diabetic foot ulcer | 8 Participants | 20 Participants | 12 Participants |
| Reference Wound Type Mixed etiology ulcer | 1 Participants | 1 Participants | 0 Participants |
| Reference Wound Type Other | 0 Participants | 0 Participants | 0 Participants |
| Reference Wound Type Pressure ulcer | 2 Participants | 7 Participants | 5 Participants |
| Reference Wound Type Venous leg ulcer | 4 Participants | 12 Participants | 8 Participants |
| Region of Enrollment United States | 15 participants | 40 participants | 25 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 9 Participants | 28 Participants | 19 Participants |
| Weight | 230.5 pounds STANDARD_DEVIATION 39.4 | 207.8 pounds STANDARD_DEVIATION 59.3 | 194.2 pounds STANDARD_DEVIATION 65.6 |
| Wound Duration | 292.9 days STANDARD_DEVIATION 275.1 | 260.1 days STANDARD_DEVIATION 211.9 | 240.3 days STANDARD_DEVIATION 166.6 |
| Wound Location Abdomen | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Ankle | 1 Participants | 4 Participants | 3 Participants |
| Wound Location Back | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Buttocks | 0 Participants | 1 Participants | 1 Participants |
| Wound Location Chest | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Foot | 8 Participants | 20 Participants | 12 Participants |
| Wound Location Head/neck | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Hips | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Lower arm | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Lower leg/knee | 4 Participants | 9 Participants | 5 Participants |
| Wound Location Other | 2 Participants | 6 Participants | 4 Participants |
| Wound Location Sacrum | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Shoulders | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Upper arm | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Upper leg | 0 Participants | 0 Participants | 0 Participants |
| Wound Location Wrist/hand | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 15 |
| other Total, other adverse events | 3 / 25 | 2 / 15 |
| serious Total, serious adverse events | 1 / 25 | 3 / 15 |
Outcome results
Primary
Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period. The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern. The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used: CWIS-PSDL = (Sum of PSDL item scores-N\_PSDL)/(N\_PSDL x 4) ×100, where NPSDL = count of 24 questions completed (experience and stress) PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale \[1-5\]) with higher scores indicating a better outcome.
Time frame: Baseline through 6 weeks
Population: Scores were calculated for the full analysis set (FAS) population (all randomized subjects who received study treatment and attended at least 1 post-Baseline visit).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | Baseline Assessment | 54.3 score on a scale | Standard Deviation 27.5 |
| ALLEVYN Life Non-Bordered | Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | Week 6 Visit Assessment | 71.2 score on a scale | Standard Deviation 24.4 |
| ALLEVYN Life Non-Bordered | Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | Change in CWIS-PSDL Scale Score | 15.3 score on a scale | Standard Deviation 23.3 |
| Standard Care | Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | Baseline Assessment | 54.0 score on a scale | Standard Deviation 34.5 |
| Standard Care | Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | Week 6 Visit Assessment | 56.3 score on a scale | Standard Deviation 27.9 |
| Standard Care | Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | Change in CWIS-PSDL Scale Score | 2.3 score on a scale | Standard Deviation 17.8 |
Secondary
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
Assessment of the change over time for the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Score at 3 and 12 weeks; CWIS-Well-Being (WB), CWIS-Social Life (SL), CWIS-Global Quality of Life (GQ), CWIS-Quality of Life Scales (SQ) at 3, 6, and 12 weeks. PSDL, SL, and WB sub-scores are based on 24 (score range 24-120), 14 (score range 14-70), and 7 (score range 7-35) questions, respectively; (each graded on a 5-point Likert scale \[1-5\]) Higher scores on all CWIS metrics indicate a better outcome. PSDL score = (sum of PSDL item scores - 24)/96 x 100 = calculated score of 0 to 100; e.g., 95-24/96 x 100 = 74 (of a possible 100) WB Score = (sum of WB item scores - 7)/28 x 100 = calculated score of 0 to 100 SL Score = (sum of SL item scores - 14)/56 x 100 = calculated score of 0 to 100 GQ Score = How good is your quality of life = score range 0 to 10 SQ Score = How satisfied are you with your overall quality of life = score range 0 to 10
Time frame: PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks
Population: Not all subjects participated in answering these questionnaire assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SQ Change at 6 Weeks | 0.7 score on a scale | Standard Deviation 2.5 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-WB Score Change at 3 Weeks | 9.5 score on a scale | Standard Deviation 18.8 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-WB Score Change at 6 Weeks | 16.1 score on a scale | Standard Deviation 23.1 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-WB Score Change at 12 Weeks | 19.2 score on a scale | Standard Deviation 24.6 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SL Score Change at 3 Weeks | 9.8 score on a scale | Standard Deviation 22.9 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SL Score Change at 6 Weeks | 14.9 score on a scale | Standard Deviation 25.4 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SL Score Change at 12 Weeks | 10.5 score on a scale | Standard Deviation 32.4 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-GQ Change at 3 Weeks | -0.0 score on a scale | Standard Deviation 3.1 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-GQ Change at 6 Weeks | 0.5 score on a scale | Standard Deviation 2.5 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SQ Change at 3 Weeks | 0.1 score on a scale | Standard Deviation 3.2 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SQ Change at 12 Weeks | 0.4 score on a scale | Standard Deviation 2.3 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-PSDL Score Change at 12 Weeks | 17.3 score on a scale | Standard Deviation 22.1 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-GQ Change at 12 Weeks | 0.6 score on a scale | Standard Deviation 2.3 |
| ALLEVYN Life Non-Bordered | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-PSDL Score Change at 3 Weeks | 6.0 score on a scale | Standard Deviation 18 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SL Score Change at 6 Weeks | 7.0 score on a scale | Standard Deviation 26.7 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-PSDL Score Change at 3 Weeks | 5.4 score on a scale | Standard Deviation 35.6 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-PSDL Score Change at 12 Weeks | 16.6 score on a scale | Standard Deviation 32.2 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-GQ Change at 6 Weeks | 0.7 score on a scale | Standard Deviation 2.3 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-WB Score Change at 3 Weeks | 13.2 score on a scale | Standard Deviation 25.7 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-GQ Change at 12 Weeks | 1.1 score on a scale | Standard Deviation 2 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-WB Score Change at 6 Weeks | 4.9 score on a scale | Standard Deviation 14.7 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-GQ Change at 3 Weeks | 0.8 score on a scale | Standard Deviation 2.3 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-WB Score Change at 12 Weeks | 18.1 score on a scale | Standard Deviation 28.5 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SQ Change at 3 Weeks | 1.1 score on a scale | Standard Deviation 2.5 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SQ Change at 6 Weeks | 1.1 score on a scale | Standard Deviation 2.2 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SL Score Change at 3 Weeks | 8.1 score on a scale | Standard Deviation 37 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SL Score Change at 12 Weeks | 16.1 score on a scale | Standard Deviation 34 |
| Standard Care | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | CWIS-SQ Change at 12 Weeks | 0.8 score on a scale | Standard Deviation 2.1 |
Secondary
Healthcare Resource Use - Number and Type of Compression Dressings Used
Not all enrolled participants required the use of compression dressings. Of those participants who did require a compression dressing, an analysis of the healthcare resources used included the number and type of primary and secondary dressings used in relation to the reference ulcer.
Time frame: Baseline through 12 weeks
Population: Two subjects from the standard care group withdrew prior to receiving treatment.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number and Type of Compression Dressings Used | Single layer inelastic | 0 Wounds |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number and Type of Compression Dressings Used | Multi layer elastic other than Profore | 15 Wounds |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number and Type of Compression Dressings Used | Support hosiery | 0 Wounds |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number and Type of Compression Dressings Used | Multi layer elastic - Profore | 16 Wounds |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number and Type of Compression Dressings Used | Other | 0 Wounds |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number and Type of Compression Dressings Used | Single layer elastic | 2 Wounds |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number and Type of Compression Dressings Used | Compression dressing application not required | 35 Wounds |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number and Type of Compression Dressings Used | Multi layer inelastic | 0 Wounds |
| Standard Care | Healthcare Resource Use - Number and Type of Compression Dressings Used | Compression dressing application not required | 15 Wounds |
| Standard Care | Healthcare Resource Use - Number and Type of Compression Dressings Used | Multi layer elastic - Profore | 7 Wounds |
| Standard Care | Healthcare Resource Use - Number and Type of Compression Dressings Used | Multi layer inelastic | 0 Wounds |
| Standard Care | Healthcare Resource Use - Number and Type of Compression Dressings Used | Single layer elastic | 2 Wounds |
| Standard Care | Healthcare Resource Use - Number and Type of Compression Dressings Used | Single layer inelastic | 0 Wounds |
| Standard Care | Healthcare Resource Use - Number and Type of Compression Dressings Used | Support hosiery | 1 Wounds |
| Standard Care | Healthcare Resource Use - Number and Type of Compression Dressings Used | Other | 0 Wounds |
| Standard Care | Healthcare Resource Use - Number and Type of Compression Dressings Used | Multi layer elastic other than Profore | 8 Wounds |
Secondary
Healthcare Resource Use - Number of Days Participants Required In-Hospital Care
Analysis of the healthcare resources used related to the reference ulcer included: Time in hospital (number of days spent as an inpatient due to reference ulcer).
Time frame: Baseline through 12 weeks
Population: Two subjects from the standard care group withdrew prior to receiving treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Healthcare Resource Use - Number of Days Participants Required In-Hospital Care | 7 Days |
Secondary
Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
Analysis of the healthcare resources used related to the reference ulcer included: Interventions/procedures related to the reference ulcer (number and type) including debridement of the ulcer.
Time frame: Baseline through 12 weeks
Population: Two subjects from the standard care group withdrew prior to receiving treatment.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Forceps debridement | 1 Dressing changes |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Curette debridement | 33 Dressing changes |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Other type of debridement | 2 Dressing changes |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Scalpel debridement | 69 Dressing changes |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Wound debridement not required as part of care | 159 Dressing changes |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Scissors debridement | 0 Dressing changes |
| Standard Care | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Wound debridement not required as part of care | 89 Dressing changes |
| Standard Care | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Scissors debridement | 0 Dressing changes |
| Standard Care | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Scalpel debridement | 26 Dressing changes |
| Standard Care | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Forceps debridement | 0 Dressing changes |
| Standard Care | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Other type of debridement | 0 Dressing changes |
| Standard Care | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Curette debridement | 11 Dressing changes |
Secondary
Healthcare Resource Use - Number of Participants Requiring Hospital Admission
Analysis of the healthcare resources used for participants who required a hospital admission related to the reference ulcer.
Time frame: Baseline through 12 weeks
Population: Two subjects from the standard care group withdrew prior to receiving treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALLEVYN Life Non-Bordered | Healthcare Resource Use - Number of Participants Requiring Hospital Admission | 0 Participants |
| Standard Care | Healthcare Resource Use - Number of Participants Requiring Hospital Admission | 1 Participants |
Secondary
Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used
Analysis of the healthcare resources used related to the reference ulcer included: Number of primary and secondary dressings including use of compression therapy.
Time frame: Baseline through 12 weeks
Population: Two subjects in the standard care group withdrew prior to receiving treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALLEVYN Life Non-Bordered | Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used | 10.4 dressings used/participant | Standard Deviation 4.8 |
| Standard Care | Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used | 18.3 dressings used/participant | Standard Deviation 20.5 |
Secondary
Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change
Analysis of the healthcare resources used related to the reference ulcer included: Type of primary and secondary dressings including compression therapy used during each dressing change over the 12-week treatment period based on the size of the ulcer.
Time frame: Baseline through 12 weeks
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change | ALLEVYN Life Non-bordered (ALNB), 10.5 x 10.5 cm | 1.0 Dressings used per change | Standard Deviation 0 |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change | ALNB, 16 x 16 cm | 1.0 Dressings used per change | Standard Deviation 0 |
| ALLEVYN Life Non-Bordered | Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change | ALNB, 10 x 20 cm | 1.0 Dressings used per change | Standard Deviation 0.1 |
| Standard Care | Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change | Standard care | 1.9 Dressings used per change | Standard Deviation 1 |
Secondary
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of necrotic tissue observed during dressing change at each time point. The tool guidance is to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to help determine percent of wound involved.
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | >75% to 100% of wound covered | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None | 18 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 25% to 50% of wound covered | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | <25% of wound bed covered | 4 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None | 18 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 25% to 50% of wound covered | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | >50% to <75% of wound covered | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | <25% of wound bed covered | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | >75% to 100% of wound covered | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 25% to 50% of wound covered | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None | 18 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | >50% to <75% of wound covered | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | <25% of wound bed covered | 4 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | >50% to <75% of wound covered | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 25% to 50% of wound covered | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | <25% of wound bed covered | 4 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | >50% to <75% of wound covered | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | >75% to 100% of wound covered | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | >75% to 100% of wound covered | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None | 19 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | >75% to 100% of wound covered | 1 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | <25% of wound bed covered | 2 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None | 10 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | <25% of wound bed covered | 1 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 25% to 50% of wound covered | 1 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | >50% to <75% of wound covered | 0 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | >75% to 100% of wound covered | 1 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None | 8 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 25% to 50% of wound covered | 0 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | >50% to <75% of wound covered | 1 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | >75% to 100% of wound covered | 0 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None | 10 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | <25% of wound bed covered | 0 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 25% to 50% of wound covered | 1 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | >50% to <75% of wound covered | 0 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | >75% to 100% of wound covered | 0 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None | 10 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | <25% of wound bed covered | 0 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 25% to 50% of wound covered | 0 Participants |
| Standard Care | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | >50% to <75% of wound covered | 0 Participants |
Secondary
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of wound exudate demonstrated at each time point. The tool gives the following category descriptions for amount of exudate: None = wound tissues dry Scant = wound tissues moist; no measurable exudate Small = wound tissues wet; moisture evenly distributed in wound; drainage involves \</=25% dressing Moderate = wound tissues saturated; drainage may or may not be evenly distributed in wound; drainage involves \>25% to \</=75% dressing Large = wound tissues bathed in fluid; drainage freely expressed; may or may not be evenly distributed in wound; drainage involves \>75% dressing The tool advises to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to determine percentage of dressing involved with exudate.
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Small | 6 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Small | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Scant, wound, moist but no observable exudate | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Small | 11 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Large | 4 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None | 5 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Scant, wound, moist but no observable exudate | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Small | 7 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Large | 4 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None | 11 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Scant, wound, moist but no observable exudate | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Moderate | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Large | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Scant, wound, moist but no observable exudate | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Moderate | 21 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Large | 4 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Moderate | 7 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Moderate | 6 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None | 0 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Scant, wound, moist but no observable exudate | 0 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None | 0 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None | 5 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Large | 2 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Small | 0 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None | 0 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Scant, wound, moist but no observable exudate | 1 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Scant, wound, moist but no observable exudate | 1 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Small | 1 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Moderate | 5 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Small | 3 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Large | 2 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Moderate | 4 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None | 2 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Moderate | 11 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Scant, wound, moist but no observable exudate | 2 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Large | 1 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Small | 2 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Moderate | 4 Participants |
| Standard Care | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Large | 1 Participants |
Secondary
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for type (appearance) of necrotic tissue at each time point. The tool defines the categories of necrotic tissue type as follows: White/gray non-viable tissue = may appear prior to wound opening; skin surface is white or gray Non-adherent, yellow slough = thin, mucinous substance; scattered throughout wound bed; easily separated from wound tissue Loosely adherent, yellow slough = thick, stringy, clumps of debris; attached to wound tissue Adherent, soft, black eschar = soggy tissue; strongly attached to tissue in center or base of wound Firmly adherent, hard/black eschar = firm, crusty tissue; strongly attached to wound base and edges (like a hard scab)
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Firmly adherent, hard, black eschar | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Adherent, soft, black eschar | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Firmly adherent, hard, black eschar | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None | 18 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | White/grey nonviable tissue and/or nonadherent yellow slough | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None | 18 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | White/grey nonviable tissue and/or nonadherent yellow slough | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None | 19 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | White/grey nonviable tissue and/or nonadherent yellow slough | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Adherent, soft, black eschar | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Firmly adherent, hard, black eschar | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None | 18 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | White/grey nonviable tissue and/or nonadherent yellow slough | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Loosely adherent yellow slough | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Loosely adherent yellow slough | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Adherent, soft, black eschar | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Firmly adherent, hard, black eschar | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Loosely adherent yellow slough | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Adherent, soft, black eschar | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Loosely adherent yellow slough | 3 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Firmly adherent, hard, black eschar | 0 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Loosely adherent yellow slough | 1 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None | 8 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | White/grey nonviable tissue and/or nonadherent yellow slough | 0 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | White/grey nonviable tissue and/or nonadherent yellow slough | 0 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Loosely adherent yellow slough | 2 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Adherent, soft, black eschar | 0 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Firmly adherent, hard, black eschar | 1 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None | 10 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None | 10 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | White/grey nonviable tissue and/or nonadherent yellow slough | 0 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Firmly adherent, hard, black eschar | 1 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None | 10 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Loosely adherent yellow slough | 0 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | White/grey nonviable tissue and/or nonadherent yellow slough | 0 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Adherent, soft, black eschar | 0 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Adherent, soft, black eschar | 2 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Adherent, soft, black eschar | 1 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Firmly adherent, hard, black eschar | 0 Participants |
| Standard Care | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Loosely adherent yellow slough | 0 Participants |
Secondary
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the extent (measurement) of wound undermining at each time point. The tool guidance is as follows: Assess by inserting a cotton-tipped applicator under the wound edge; Advance it as far as it will go without using undue force; Raise the tip of the applicator so it may be seen or felt on the surface of the skin; Mark the surface with a pen; Measure the distance from the mark on the skin to the edge of the wound; Continue process around the wound; Then use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved.
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | >4 cm or tunnelling in any area | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | <2 cm in any area | 4 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 2-4 cm involving <50% wound margins | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 2-4 cm involving >50% wound margins | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | >4 cm or tunnelling in any area | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None present | 21 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 2-4 cm involving <50% wound margins | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 2-4 cm involving >50% wound margins | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | >4 cm or tunnelling in any area | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None present | 23 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 2-4 cm involving <50% wound margins | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 2-4 cm involving >50% wound margins | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | <2 cm in any area | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None present | 23 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | <2 cm in any area | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 2-4 cm involving <50% wound margins | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 2-4 cm involving >50% wound margins | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | >4 cm or tunnelling in any area | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | <2 cm in any area | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None present | 19 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | <2 cm in any area | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None present | 11 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | <2 cm in any area | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | <2 cm in any area | 2 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None present | 12 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 2-4 cm involving <50% wound margins | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 2-4 cm involving <50% wound margins | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 2-4 cm involving >50% wound margins | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | >4 cm or tunnelling in any area | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | >4 cm or tunnelling in any area | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 2-4 cm involving >50% wound margins | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None present | 9 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | <2 cm in any area | 2 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 2-4 cm involving >50% wound margins | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 2-4 cm involving <50% wound margins | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None present | 11 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 2-4 cm involving >50% wound margins | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 2-4 cm involving <50% wound margins | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | >4 cm or tunnelling in any area | 0 Participants |
| Standard Care | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | >4 cm or tunnelling in any area | 0 Participants |
Secondary
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the type of wound exudate exhibited at each time point. The tool defines the types of exudate as follows: Bloody = thin, bright red Serosanguinous = thin, watery, pale red to pink Serous = thin, watery, clear Purulent = thin or thick, opaque tan to yellow Foul purulent = thick, opaque yellow to green with offensive odor
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Purulent | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Serous | 11 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Serous | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Purulent | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Serosanguineous | 9 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Bloody | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None | 11 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Serosanguineous | 12 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Bloody | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Serosanguineous | 16 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Serosanguineous | 9 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Purulent | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Serous | 6 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Bloody | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Purulent | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Bloody | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None | 5 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Serous | 9 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None | 0 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Bloody | 1 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | None | 0 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Bloody | 1 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Serosanguineous | 7 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Serous | 5 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Purulent | 0 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | None | 0 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Bloody | 0 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Serosanguineous | 7 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Serosanguineous | 3 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Serous | 5 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Serosanguineous | 2 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Purulent | 0 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | None | 5 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Bloody | 1 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Serous | 3 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Purulent | 1 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Serous | 4 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Purulent | 0 Participants |
| Standard Care | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | None | 2 Participants |
Secondary
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the percentage of reference wound demonstrating epithelialization at each time point. Epithelialization is the process of epidermal resurfacing and appears as pink or red skin. In partial-thickness wounds, it can occur throughout the wound bed as well as from the wound edges. In full-thickness wounds, it occurs from the edges only. Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved and to measure the distance the epithelial tissue extends into the wound. The mBWAT 13 categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization.
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 25% - <50% wound covered | 5 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 100% wound covered, surface intact | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 100% wound covered, surface intact | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed | 6 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed | 6 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 25% - <50% wound covered | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 25% - <50% wound covered | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed | 6 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | <25% wound covered | 11 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 100% wound covered, surface intact | 9 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed | 5 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 25% - <50% wound covered | 4 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 100% wound covered, surface intact | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | <25% wound covered | 10 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | <25% wound covered | 4 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | <25% wound covered | 13 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | <25% wound covered | 2 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed | 0 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 100% wound covered, surface intact | 0 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed | 4 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed | 0 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | 25% - <50% wound covered | 1 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | <25% wound covered | 8 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 100% wound covered, surface intact | 0 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed | 3 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | 25% - <50% wound covered | 2 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | <25% wound covered | 6 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 100% wound covered, surface intact | 1 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed | 2 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed | 2 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | 25% - <50% wound covered | 2 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | <25% wound covered | 4 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 100% wound covered, surface intact | 5 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed | 4 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed | 0 Participants |
| Standard Care | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | 25% - <50% wound covered | 1 Participants |
Secondary
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance and percentage of granulation tissue in the reference wound at each time point. Granulation tissue is the growth of small blood vessels and connective tissue to fill in full-thickness wounds. Tissue is healthy when bright, beefy red, shiny, and granular with a velvety appearance. Poor vascular supply appears as pale-pink or blanched to dull, dusky red color.
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Bright, beefy red; 75-100% wound filled/ or tissue overgrowth | 10 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Skin intact or partial-thickness wound | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Skin intact or partial-thickness wound | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Bright, beefy red; 75-100% wound filled/ or tissue overgrowth | 9 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Skin intact or partial-thickness wound | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Bright, beefy red; <75% & >25% wound filled | 9 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Bright, beefy red; 75-100% wound filled/ or tissue overgrowth | 10 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Pink and/or dull, dusky red and/or fills ≤25% of wound | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | No granulation tissue present | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Bright, beefy red; <75% & >25% wound filled | 8 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Skin intact or partial-thickness wound | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Bright, beefy red; <75% & >25% wound filled | 8 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Bright, beefy red; 75-100% wound filled/ or tissue overgrowth | 11 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | No granulation tissue present | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Bright, beefy red; <75% & >25% wound filled | 8 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Pink and/or dull, dusky red and/or fills ≤25% of wound | 5 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Pink and/or dull, dusky red and/or fills ≤25% of wound | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Pink and/or dull, dusky red and/or fills ≤25% of wound | 7 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | No granulation tissue present | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | No granulation tissue present | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | No granulation tissue present | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Pink and/or dull, dusky red and/or fills ≤25% of wound | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Skin intact or partial-thickness wound | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Bright, beefy red; 75-100% wound filled/ or tissue overgrowth | 6 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Bright, beefy red; <75% & >25% wound filled | 2 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | No granulation tissue present | 1 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Skin intact or partial-thickness wound | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Bright, beefy red; 75-100% wound filled/ or tissue overgrowth | 6 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Bright, beefy red; <75% & >25% wound filled | 2 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Pink and/or dull, dusky red and/or fills ≤25% of wound | 3 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | No granulation tissue present | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Skin intact or partial-thickness wound | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Bright, beefy red; 75-100% wound filled/ or tissue overgrowth | 8 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Bright, beefy red; <75% & >25% wound filled | 3 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | No granulation tissue present | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Skin intact or partial-thickness wound | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Bright, beefy red; 75-100% wound filled/ or tissue overgrowth | 8 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Bright, beefy red; <75% & >25% wound filled | 3 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Pink and/or dull, dusky red and/or fills ≤25% of wound | 0 Participants |
| Standard Care | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Pink and/or dull, dusky red and/or fills ≤25% of wound | 4 Participants |
Secondary
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Evaluation of the number of participants demonstrating peri-wound changes in appearance as determined visually by the Investigator; categorized as normal, erythematous, edematous, eczematous, excoriated, macerated, or indurated at each time point.
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Macerated | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Macerated | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Edematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Edematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Erythematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Edematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Eczematous | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Excoriated | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Indurated | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Normal | 20 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Erythematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Edematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Eczematous | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Excoriated | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Macerated | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Indurated | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Normal | 20 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Erythematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Eczematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Excoriated | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Normal | 22 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Indurated | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Normal | 21 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Erythematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Eczematous | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Excoriated | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Macerated | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Indurated | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Excoriated | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Normal | 11 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Excoriated | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Macerated | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Macerated | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Edematous | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Erythematous | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Eczematous | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Edematous | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Indurated | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Erythematous | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Indurated | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Edematous | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Normal | 8 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Eczematous | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Macerated | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Macerated | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Erythematous | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Baseline | Indurated | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Normal | 8 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Normal | 9 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Eczematous | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Erythematous | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Excoriated | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Edematous | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 6 | Excoriated | 0 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 3 | Eczematous | 1 Participants |
| Standard Care | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Week 12 | Indurated | 0 Participants |
Secondary
Number of Participants With Reference Wound Healed
Assessment of the wound healed status (100% re-epithelialized, no drainage, no need for dressing) was analyzed at each visit to determine the healing status of the ulcer. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data.
Time frame: Weeks 3, 6 and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants With Reference Wound Healed | Week 3, reference ulcer healed | No | 23 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Reference Wound Healed | Week 3, reference ulcer healed | Yes | 1 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Reference Wound Healed | Week 6, reference ulcer healed | No | 22 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Reference Wound Healed | Week 6, reference ulcer healed | Yes | 2 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Reference Wound Healed | Week 12, reference ulcer healed | No | 15 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Reference Wound Healed | Week 12, reference ulcer healed | Yes | 9 Participants |
| Standard Care | Number of Participants With Reference Wound Healed | Week 12, reference ulcer healed | No | 8 Participants |
| Standard Care | Number of Participants With Reference Wound Healed | Week 3, reference ulcer healed | No | 11 Participants |
| Standard Care | Number of Participants With Reference Wound Healed | Week 6, reference ulcer healed | Yes | 1 Participants |
| Standard Care | Number of Participants With Reference Wound Healed | Week 3, reference ulcer healed | Yes | 0 Participants |
| Standard Care | Number of Participants With Reference Wound Healed | Week 12, reference ulcer healed | Yes | 5 Participants |
| Standard Care | Number of Participants With Reference Wound Healed | Week 6, reference ulcer healed | No | 10 Participants |
Secondary
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance of skin color changes surrounding the reference wound at each time point. The tool guidance is to assess tissues within 4 cm of wound edge. Dark-skinned persons show the colors bright red and dark red as a deepening of normal ethnic skin color or a purple hue. As healing occurs in dark-skinned persons, the new skin is pink and may never darken.
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Pink or normal for ethnic group | 23 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Dark red/ or purple and/or nonblanchable | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | White or grey pallor or hypopigmented | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Pink or normal for ethnic group | 23 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | White or grey pallor or hypopigmented | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Bright red and/or blanches to touch | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Bright red and/or blanches to touch | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | White or grey pallor or hypopigmented | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Black or hyperpigmented | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Dark red/ or purple and/or nonblanchable | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Pink or normal for ethnic group | 22 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Black or hyperpigmented | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Dark red/ or purple and/or nonblanchable | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Pink or normal for ethnic group | 23 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Black or hyperpigmented | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Bright red and/or blanches to touch | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Bright red and/or blanches to touch | 3 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Black or hyperpigmented | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Dark red/ or purple and/or nonblanchable | 0 Participants |
| ALLEVYN Life Non-Bordered | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | White or grey pallor or hypopigmented | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Black or hyperpigmented | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Pink or normal for ethnic group | 10 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Bright red and/or blanches to touch | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Dark red/ or purple and/or nonblanchable | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | Black or hyperpigmented | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Pink or normal for ethnic group | 10 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Dark red/ or purple and/or nonblanchable | 1 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Pink or normal for ethnic group | 12 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Bright red and/or blanches to touch | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | White or grey pallor or hypopigmented | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Black or hyperpigmented | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 3 | White or grey pallor or hypopigmented | 1 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Bright red and/or blanches to touch | 1 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | White or grey pallor or hypopigmented | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Dark red/ or purple and/or nonblanchable | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 6 | Black or hyperpigmented | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Pink or normal for ethnic group | 9 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | Bright red and/or blanches to touch | 0 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Week 12 | White or grey pallor or hypopigmented | 1 Participants |
| Standard Care | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Baseline | Dark red/ or purple and/or nonblanchable | 1 Participants |
Secondary
Ulcer Progression Assessed by Change From Baseline in Wound Area
The change from Baseline of the wound area was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound area measurements.
Time frame: Baseline, Weeks 3, 6 and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 3, change in wound area | -0.6 cm^2 | Standard Deviation 10.6 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 6, change in wound area | -0.5 cm^2 | Standard Deviation 12.2 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 3, wound area | 9.9 cm^2 | Standard Deviation 13.3 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 12, wound area | 7.9 cm^2 | Standard Deviation 15.8 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 6, wound area | 9.7 cm^2 | Standard Deviation 16.1 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 12, change in wound area | 1.4 cm^2 | Standard Deviation 13.7 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Area | Baseline, wound area | 8.9 cm^2 | Standard Deviation 11.9 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 12, change in wound area | 0.0 cm^2 | Standard Deviation 16.4 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Area | Baseline, wound area | 8.7 cm^2 | Standard Deviation 8.9 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 3, wound area | 4.9 cm^2 | Standard Deviation 6.4 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 3, change in wound area | 2.2 cm^2 | Standard Deviation 4.6 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 6, wound area | 3.7 cm^2 | Standard Deviation 6.5 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 6, change in wound area | 3.3 cm^2 | Standard Deviation 5 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Area | Week 12, wound area | 6.7 cm^2 | Standard Deviation 18.5 |
Secondary
Ulcer Progression Assessed by Change From Baseline in Wound Depth
The change from Baseline in the wound depth was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound depth measurements.
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Baseline, wound depth | 2.8 mm | Standard Deviation 3.6 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 3, change in wound depth | 1.0 mm | Standard Deviation 2.9 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 6, wound depth | 1.9 mm | Standard Deviation 2.3 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 6, change in wound depth | 0.9 mm | Standard Deviation 3.3 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 12, wound depth | 1.3 mm | Standard Deviation 1.9 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 3, wound depth | 1.8 mm | Standard Deviation 1.8 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 12, change in wound depth | 1.6 mm | Standard Deviation 3.7 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 3, wound depth | 2.7 mm | Standard Deviation 4.3 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 12, wound depth | 0.9 mm | Standard Deviation 1.6 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 3, change in wound depth | 1.2 mm | Standard Deviation 2 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Baseline, wound depth | 3.8 mm | Standard Deviation 5 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 6, wound depth | 1.5 mm | Standard Deviation 2 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 12, change in wound depth | 3.1 mm | Standard Deviation 5 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Depth | Week 6, change in wound depth | 2.4 mm | Standard Deviation 5.1 |
Secondary
Ulcer Progression Assessed by Change From Baseline in Wound Volume
The change from Baseline of the wound volume was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound volume measurements.
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 12, change in wound volume | 0.6 cm^3 | Standard Deviation 1.9 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 6, change in wound volume | -0.1 cm^3 | Standard Deviation 3.1 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Baseline, wound volume | 2.7 cm^3 | Standard Deviation 5.2 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 3, wound volume | 2.5 cm^3 | Standard Deviation 5.7 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 3, change in wound volume | 0.3 cm^3 | Standard Deviation 1.6 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 12, wound volume | 2.2 cm^3 | Standard Deviation 5.6 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 6, wound volume | 2.9 cm^3 | Standard Deviation 7.3 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 3, change in wound volume | 1.0 cm^3 | Standard Deviation 1.7 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 3, wound volume | 1.0 cm^3 | Standard Deviation 1.9 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 6, change in wound volume | 1.1 cm^3 | Standard Deviation 2.3 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 12, wound volume | 2.8 cm^3 | Standard Deviation 9.3 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 12, change in wound volume | -0.8 cm^3 | Standard Deviation 8 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Week 6, wound volume | 0.9 cm^3 | Standard Deviation 2.6 |
| Standard Care | Ulcer Progression Assessed by Change From Baseline in Wound Volume | Baseline, wound volume | 2.1 cm^3 | Standard Deviation 2.6 |
Secondary
Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) for an overall wound score at each time point. The mBWAT score combined the sub-scores of mBWAT - a tool that has been in widespread use since the early 1990s. mBWAT scoring: There are 13 categories of assessment with item-level score range of 1 to 5 on a modified Likert scale. Each item is scored for the wound characteristic it describes where 1 indicates least severe and 5 indicates most severe with higher scores indicating a more severe wound status. Scores taken over a period of time can be used to track the progression of the wound healing process. Possible score range from 13 to 65 for the total score. The 13 sub-categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization
Time frame: Baseline, Weeks 3, 6, and 12
Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Baseline Score | 19.8 score on a scale | Standard Deviation 3.2 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Week 3 Score | 18.5 score on a scale | Standard Deviation 2.8 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Week 6 Score | 17.3 score on a scale | Standard Deviation 3.9 |
| ALLEVYN Life Non-Bordered | Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Week 12 Score | 16.4 score on a scale | Standard Deviation 3.7 |
| Standard Care | Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Week 12 Score | 17.4 score on a scale | Standard Deviation 5.7 |
| Standard Care | Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Baseline Score | 20 score on a scale | Standard Deviation 4.2 |
| Standard Care | Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Week 6 Score | 17.0 score on a scale | Standard Deviation 2.9 |
| Standard Care | Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Week 3 Score | 19.4 score on a scale | Standard Deviation 4.4 |