Full Thickness Skin Defects, Ulcer
Conditions
Keywords
Full Thickness Skin Defects, Ulcer, Negative Pressure Wound Therapy, High Purity Type 1 Collagen, Helicoll
Brief summary
Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.
Detailed description
Full-thickness wounds, extending through the dermis and affecting underlying tissues, present significant clinical challenges due to their complexity and prolonged healing times. Traditional treatments include surgical debridement, dressings, and advanced therapies like Negative Pressure Wound Therapy (NPWT). Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. Studies suggest that HPTC promote cellular proliferation and angiogenesis, essential for tissue regeneration. Given the distinct mechanisms of action of NPWT and HPTC, a comparative evaluation is warranted to determine their relative efficacy in treating full-thickness wounds. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.
Interventions
DEVICEHigh Purity Type-I Collagen based Skin Substitute
In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
DEVICENegative Pressure Wound Therapy
In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
Sponsors
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must be at least 18 years of age or older. 2. Presence of a full-thickness wound of at least 4 cm² and no more than 100 cm². 3. Wound duration of at least 4 weeks but not exceeding 6 months of standard of care prior to the initial screening visit. 4. Adequate vascular supply to the affected area 5. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. 6. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol. 7. The subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Wound Area | 7 weeks | Percentage change in wound area from week 1 through week 7 measured manually with digital photography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histopathological Analysis on Day 5 of Study - Capillary Density | 5 days | Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for capillary density (vessels per mm²) - higher count means better, |
| Time to Achieve Complete Wound Closure | 7 weeks | The time to achieve complete wound closure of the target ulcer by the end of 7 weeks |
| Percentage of Participants to Obtain Complete Wound Closure | 7 weeks | The percentage of participants that obtain complete wound closure over the 7 weeks (6 weeks treatment period plus 1 week follow up) |
| Percentage of Participants Achieving ≥50% Wound Healing | 7 weeks | Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up |
| Histopathological Analysis on Day 5 of Study | 5 days | Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for: vascular infiltration (0-3 scale) - higher score means better, neo-epithelialization (0-3 scale) - higher score means better, fibroblast activity (0-3 scale) - higher score means better, inflammatory response (0-3 scale) - lower score means better and collagen deposition (0-3 scale) - higher score means better |
| Number of Adverse Events | 6 weeks | Number of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues) |
| Pain Score on Visual Analog Scale | 7 weeks | Pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0=no pain to 10=severe pain |
| Healed Wound Appearance Assessment Using Vancouver Scar Scale | 7 weeks | The resultant new skin is assessed and documented at each visit using the Vancouver Scar Scale, up to 7 weeks, week 7 visit reported, assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar) |
| Quality of Life Assessment | 7 weeks | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument is a standardized patient-reported outcome measure assessing overall health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scoring and Ranges: 1. EQ-5D-5L Index Score - Derived from the five dimensions with five levels each (1 = no problems; 5 = extreme problems). The index score range varies by population value set; for most countries the possible scoring range is approximately -0.594 to 1.000. Higher scores indicate better health status (1.000 = full health). 2. EQ Visual Analogue Scale (EQ-VAS) - A self-rated health scale from 0 to 100, where, 0 = the worst health you can imagine, 100 = the best health you can imagine. Higher values reflect better outcomes. Interpretation: Higher scores on both the EQ-5D-5L Index and EQ-VAS represent improved quality of life and a better treatment outcome. |
| Mean Number of Application | 6 weeks | Mean number of rapplications of the NPWT+HPTC & NPWT alone used to obtain wound closure |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need.
High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | 52 |
| Negative Pressure Wound Therapy In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need.
Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | 52 |
| Total | 104 |
Baseline characteristics
| Characteristic | Negative Pressure Wound Therapy | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Total |
|---|---|---|---|
| Age, Customized | 55.3 years STANDARD_DEVIATION 11.7 | 54.1 years STANDARD_DEVIATION 12.2 | 54.7 years STANDARD_DEVIATION 11.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment India | 52 participants | 52 participants | 104 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 33 Participants | 34 Participants | 67 Participants |
| Wound area (cm²) | 33.6 square centimeters STANDARD_DEVIATION 17.9 | 32.8 square centimeters STANDARD_DEVIATION 18.5 | 33.18 square centimeters STANDARD_DEVIATION 18.11 |
| Wound duration (weeks) | 5.1 weeks STANDARD_DEVIATION 3.1 | 4.1 weeks STANDARD_DEVIATION 2.9 | 4.6 weeks STANDARD_DEVIATION 3 |
| Wound etiology, n (%) Burns | 8 Participants | 8 Participants | 16 Participants |
| Wound etiology, n (%) Diabetic | 10 Participants | 8 Participants | 18 Participants |
| Wound etiology, n (%) Pressure | 5 Participants | 7 Participants | 12 Participants |
| Wound etiology, n (%) Surgical | 10 Participants | 10 Participants | 20 Participants |
| Wound etiology, n (%) Traumatic | 14 Participants | 12 Participants | 26 Participants |
| Wound etiology, n (%) Vascular | 5 Participants | 7 Participants | 12 Participants |
| Wound location, n (%) Abdomen | 5 Participants | 4 Participants | 9 Participants |
| Wound location, n (%) Back | 3 Participants | 2 Participants | 5 Participants |
| Wound location, n (%) Chest | 9 Participants | 10 Participants | 19 Participants |
| Wound location, n (%) Head and Neck | 0 Participants | 0 Participants | 0 Participants |
| Wound location, n (%) Lower Limb | 23 Participants | 28 Participants | 51 Participants |
| Wound location, n (%) Upper limb | 12 Participants | 8 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 5 / 52 | 8 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
Percentage Change in Wound Area
Percentage change in wound area from week 1 through week 7 measured manually with digital photography
Time frame: 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 7 weeks | 89.35 percentage change | Standard Deviation 16.08 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 1 week | 23.73 percentage change | Standard Deviation 11.45 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 2 weeks | 34.47 percentage change | Standard Deviation 13.28 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 3 weeks | 45.17 percentage change | Standard Deviation 14.67 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 4 weeks | 56.45 percentage change | Standard Deviation 15.82 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 5 weeks | 67.14 percentage change | Standard Deviation 16.45 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 6 weeks | 78.33 percentage change | Standard Deviation 16.98 |
| Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 7 weeks | 57.85 percentage change | Standard Deviation 12.73 |
| Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 4 weeks | 36.62 percentage change | Standard Deviation 12.74 |
| Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 1 week | 15.21 percentage change | Standard Deviation 9.32 |
| Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 6 weeks | 50.83 percentage change | Standard Deviation 13.72 |
| Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 2 weeks | 22.52 percentage change | Standard Deviation 10.85 |
| Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 5 weeks | 43.97 percentage change | Standard Deviation 13.28 |
| Negative Pressure Wound Therapy | Percentage Change in Wound Area | Wound area reduction at 3 weeks | 29.85 percentage change | Standard Deviation 11.98 |
Secondary
Healed Wound Appearance Assessment Using Vancouver Scar Scale
The resultant new skin is assessed and documented at each visit using the Vancouver Scar Scale, up to 7 weeks, week 7 visit reported, assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar)
Time frame: 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Healed Wound Appearance Assessment Using Vancouver Scar Scale | 3.9 scores on a scale | Standard Deviation 1.8 |
| Negative Pressure Wound Therapy | Healed Wound Appearance Assessment Using Vancouver Scar Scale | 9.2 scores on a scale | Standard Deviation 2.5 |
Secondary
Histopathological Analysis on Day 5 of Study
Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for: vascular infiltration (0-3 scale) - higher score means better, neo-epithelialization (0-3 scale) - higher score means better, fibroblast activity (0-3 scale) - higher score means better, inflammatory response (0-3 scale) - lower score means better and collagen deposition (0-3 scale) - higher score means better
Time frame: 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | neo-epithelialization (0-3 scale) | 2.73 score on a scale | Standard Deviation 0.61 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | inflammatory response (0-3 scale) | 1.32 score on a scale | Standard Deviation 0.48 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | fibroblast activity (0-3 scale) | 2.79 score on a scale | Standard Deviation 0.68 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | collagen deposition (0-3 scale) | 2.78 score on a scale | Standard Deviation 0.64 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | vascular infiltration (0-3 scale) | 2.82 score on a scale | Standard Deviation 0.65 |
| Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | collagen deposition (0-3 scale) | 1.43 score on a scale | Standard Deviation 0.49 |
| Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | vascular infiltration (0-3 scale) | 2.10 score on a scale | Standard Deviation 0.58 |
| Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | neo-epithelialization (0-3 scale) | 1.72 score on a scale | Standard Deviation 0.54 |
| Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | fibroblast activity (0-3 scale) | 1.63 score on a scale | Standard Deviation 0.52 |
| Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study | inflammatory response (0-3 scale) | 2.35 score on a scale | Standard Deviation 0.63 |
Secondary
Histopathological Analysis on Day 5 of Study - Capillary Density
Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for capillary density (vessels per mm²) - higher count means better,
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study - Capillary Density | 48.51 vessels per mm² | Standard Deviation 8.32 |
| Negative Pressure Wound Therapy | Histopathological Analysis on Day 5 of Study - Capillary Density | 42.97 vessels per mm² | Standard Deviation 7.85 |
Secondary
Mean Number of Application
Mean number of rapplications of the NPWT+HPTC & NPWT alone used to obtain wound closure
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Mean Number of Application | 1.83 number of applications | Standard Deviation 0.82 |
| Negative Pressure Wound Therapy | Mean Number of Application | 4.3 number of applications | Standard Deviation 1.72 |
Secondary
Number of Adverse Events
Number of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues)
Time frame: 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Number of Adverse Events | NPWT seal issues | 1 number of adverse events |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Number of Adverse Events | Skin irritation around wound | 1 number of adverse events |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Number of Adverse Events | Allergic reaction | 1 number of adverse events |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Number of Adverse Events | Pain during dressing change | 0 number of adverse events |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Number of Adverse Events | Severe infection requiring IV antibiotics | 0 number of adverse events |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Number of Adverse Events | Superficial wound infection | 2 number of adverse events |
| Negative Pressure Wound Therapy | Number of Adverse Events | Severe infection requiring IV antibiotics | 0 number of adverse events |
| Negative Pressure Wound Therapy | Number of Adverse Events | Pain during dressing change | 2 number of adverse events |
| Negative Pressure Wound Therapy | Number of Adverse Events | Superficial wound infection | 3 number of adverse events |
| Negative Pressure Wound Therapy | Number of Adverse Events | Skin irritation around wound | 1 number of adverse events |
| Negative Pressure Wound Therapy | Number of Adverse Events | NPWT seal issues | 2 number of adverse events |
| Negative Pressure Wound Therapy | Number of Adverse Events | Allergic reaction | 0 number of adverse events |
Secondary
Pain Score on Visual Analog Scale
Pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0=no pain to 10=severe pain
Time frame: 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 7 | 1.51 scores on a scale | Standard Deviation 1.48 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Baseline | 7.38 scores on a scale | Standard Deviation 1.85 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 1 | 6.36 scores on a scale | Standard Deviation 1.78 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 2 | 5.71 scores on a scale | Standard Deviation 1.72 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 3 | 4.73 scores on a scale | Standard Deviation 1.68 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 4 | 3.98 scores on a scale | Standard Deviation 1.62 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 5 | 2.86 scores on a scale | Standard Deviation 1.58 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 6 | 1.96 scores on a scale | Standard Deviation 1.52 |
| Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 6 | 3.83 scores on a scale | Standard Deviation 1.68 |
| Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 7 | 3.17 scores on a scale | Standard Deviation 1.65 |
| Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 3 | 5.37 scores on a scale | Standard Deviation 1.79 |
| Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Baseline | 7.16 scores on a scale | Standard Deviation 1.92 |
| Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 5 | 4.28 scores on a scale | Standard Deviation 1.72 |
| Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 1 | 6.42 scores on a scale | Standard Deviation 1.82 |
| Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 4 | 4.94 scores on a scale | Standard Deviation 1.75 |
| Negative Pressure Wound Therapy | Pain Score on Visual Analog Scale | Week 2 | 5.97 scores on a scale | Standard Deviation 1.85 |
Secondary
Percentage of Participants Achieving ≥50% Wound Healing
Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up
Time frame: 7 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Percentage of Participants Achieving ≥50% Wound Healing | 49 Participants |
| Negative Pressure Wound Therapy | Percentage of Participants Achieving ≥50% Wound Healing | 27 Participants |
Secondary
Percentage of Participants to Obtain Complete Wound Closure
The percentage of participants that obtain complete wound closure over the 7 weeks (6 weeks treatment period plus 1 week follow up)
Time frame: 7 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Percentage of Participants to Obtain Complete Wound Closure | 45 Participants |
| Negative Pressure Wound Therapy | Percentage of Participants to Obtain Complete Wound Closure | 22 Participants |
Secondary
Quality of Life Assessment
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument is a standardized patient-reported outcome measure assessing overall health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scoring and Ranges: 1. EQ-5D-5L Index Score - Derived from the five dimensions with five levels each (1 = no problems; 5 = extreme problems). The index score range varies by population value set; for most countries the possible scoring range is approximately -0.594 to 1.000. Higher scores indicate better health status (1.000 = full health). 2. EQ Visual Analogue Scale (EQ-VAS) - A self-rated health scale from 0 to 100, where, 0 = the worst health you can imagine, 100 = the best health you can imagine. Higher values reflect better outcomes. Interpretation: Higher scores on both the EQ-5D-5L Index and EQ-VAS represent improved quality of life and a better treatment outcome.
Time frame: 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Quality of Life Assessment | EQ-5D Index Score | 0.91 scores on a scale | Standard Deviation 0.102 |
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Quality of Life Assessment | EQ-VAS (0-100) | 88.2 scores on a scale | Standard Deviation 8.3 |
| Negative Pressure Wound Therapy | Quality of Life Assessment | EQ-5D Index Score | 0.71 scores on a scale | Standard Deviation 0.116 |
| Negative Pressure Wound Therapy | Quality of Life Assessment | EQ-VAS (0-100) | 72.1 scores on a scale | Standard Deviation 9 |
Secondary
Time to Achieve Complete Wound Closure
The time to achieve complete wound closure of the target ulcer by the end of 7 weeks
Time frame: 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | Time to Achieve Complete Wound Closure | 36.81 days | Standard Deviation 12.88 |
| Negative Pressure Wound Therapy | Time to Achieve Complete Wound Closure | 43.94 days | Standard Deviation 16.7 |