Venous Leg Ulcer
Conditions
Keywords
wound reduction wound healing, venous ulcers
Brief summary
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber®Gelling Fibre Dressing or Aquacel®Extra Hydrofiber® Dressing with Strengthening Fibre using, centralized randomization
Detailed description
Visits are planned for baseline followed by 1, 2, 3, 4 and 6 weeks post treatment. The sub-group of at least 50 subjects will also be followed at week 8, 12, 16, 20, and 24 post treatment or until wound is healed if earlier.
Interventions
DEVICEExufiber Gelling Fibre Dressing
Gelling fibre dressing
DEVICEAquacel Extra Hydrofiber® Dressing with Strengthening Fibre
Hydrofiber® Dressing with Strengthening Fibre
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form 2. Both gender ≥18 years old 3. Ulcer moderately or strongly exudative justifying the use of an absorbent dressing 4. (History of compression at least two weeks before inclusion) Deleted in Am.2 5. (Wound covered with slough ≥70%) Deleted in Am.4 6. 0.7≤ABPI\<1.3 7. Ulcer duration 6 weeks to 60 months 8. Ulcer size 3 cm2-100 cm2 9. Target ulcer at least 3 cm away from any other lesion
Exclusion criteria
1. Known allergy/hypersensitivity to the dressings 2. Pregnant or breastfeeding 3. Circumferential wounds (the entire wound should be able to be captured on a single image/photo) 4. Subjects who will have problems following the protocol 5. Subjects included in other ongoing clinical investigation evaluating wound dressings at present or during the past 30 days 6. Patient with a systemic infection not controlled by suitable antibiotic treatment 7. Clinically infected wound according to the judgement of the investigator (heat, pain, swelling, redness or purulent secretion) 8. Wound covered with black necrosis 9. Dry wounds 10. Malignant wound degeneration 11. Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids if any 12. Subject with deep vein thrombosis within 3 months prior to inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Area Change (%) | 6 weeks | The primary endpoint was to measure relative reduction of wound area (%) from baseline to end of investigation (up to 6 weeks measured by the validated system PictZar on the photos taken after debridement at week 0, week 4, and week 6 (or final visit if healed earlier) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Area Change (cm2) | 6 weeks | The secondary endpoint was to measure relative reduction of wound area (cm2) from baseline to end of investigation (up to 6 weeks measured by the validated system PictZar on the photos taken after debridement at week 0, week 4, and week 6 (or final visit if healed earlier) |
| Linear Advance of Wound Margin | 6 weeks | Linear advance of the wound margin according to Gilman's formula (G= \[(A0-An) / ((P0+Pn) / 2)\] / Time) was calculated and evaluated using the validated system PictZar on the photos taken after debridement. The values represent wound margin advanced inwards over time (i.e., reduction in perimeter) presented in cm/day. |
| Pain During Debridement | 6 weeks | Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever. |
| Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | 6 weeks | Clinician reported outcomed by means a questionnaire was used to capture opinions related to the two dressing types. Reply alternatives varied between very poor, poor, good, very good. Results reported as 'very good' are presented as a percentage based on all follow-up visits aggregated. |
| Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features | 6 weeks | Clinician reported outcomed by means a questionnaire was used to capture opinions related to the two dressing types. Reply alternatives varied between does not adhere, adhere a little, adhere a lot. Results reported as 'does not adhere' are presented as a percentage based on all follow-up visits aggregated. |
| Pain at Dressing Removal | 6 weeks | Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Healed Wounds | from baseline to 24 weeks | Wound healing assessments were based on blind independent clinical review of photos. |
Countries
Czechia, Denmark, France, Germany, Poland, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exufiber Investigational device: Exufiber Gelling fibre dressing | 122 |
| Aquacel Comparator: Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre | 123 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Serious Adverse Event | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
| Overall Study | Wound healed | 3 | 3 |
Baseline characteristics
| Characteristic | Exufiber | Aquacel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 81 Participants | 76 Participants | 157 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 47 Participants | 88 Participants |
| Age, Continuous | 70.0 years STANDARD_DEVIATION 12.3 | 69.0 years STANDARD_DEVIATION 15 | 69.5 years STANDARD_DEVIATION 13.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants | 30 Participants | 63 Participants |
| Race (NIH/OMB) White | 89 Participants | 93 Participants | 182 Participants |
| Region of Enrollment Czechia | 17 participants | 21 participants | 38 participants |
| Region of Enrollment Denmark | 3 participants | 6 participants | 9 participants |
| Region of Enrollment France | 21 participants | 25 participants | 46 participants |
| Region of Enrollment Germany | 18 participants | 15 participants | 33 participants |
| Region of Enrollment Poland | 48 participants | 51 participants | 99 participants |
| Region of Enrollment Sweden | 15 participants | 5 participants | 20 participants |
| Sex: Female, Male Female | 62 Participants | 69 Participants | 131 Participants |
| Sex: Female, Male Male | 60 Participants | 54 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 124 | 1 / 124 |
| other Total, other adverse events | 18 / 124 | 19 / 124 |
| serious Total, serious adverse events | 5 / 124 | 8 / 124 |
Outcome results
Primary
Wound Area Change (%)
The primary endpoint was to measure relative reduction of wound area (%) from baseline to end of investigation (up to 6 weeks measured by the validated system PictZar on the photos taken after debridement at week 0, week 4, and week 6 (or final visit if healed earlier)
Time frame: 6 weeks
Population: PP analysis set, tested for non-inferiority
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exufiber | Wound Area Change (%) | -49.7 relative wound area change in percentage |
| Aquacel | Wound Area Change (%) | -42.4 relative wound area change in percentage |
p-value: 0.09395% CI: [-63.5, 3.2]Fisher Exact
Secondary
Linear Advance of Wound Margin
Linear advance of the wound margin according to Gilman's formula (G= \[(A0-An) / ((P0+Pn) / 2)\] / Time) was calculated and evaluated using the validated system PictZar on the photos taken after debridement. The values represent wound margin advanced inwards over time (i.e., reduction in perimeter) presented in cm/day.
Time frame: 6 weeks
Population: ITT analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exufiber | Linear Advance of Wound Margin | 0.008 cm/day | Standard Deviation 0.01 |
| Aquacel | Linear Advance of Wound Margin | 0.007 cm/day | Standard Deviation 0.01 |
Secondary
Pain at Dressing Removal
Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.
Time frame: 6 weeks
Population: ITT analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exufiber | Pain at Dressing Removal | 16.3 mm | Standard Deviation 22 |
| Aquacel | Pain at Dressing Removal | 16.9 mm | Standard Deviation 22.8 |
Secondary
Pain During Debridement
Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.
Time frame: 6 weeks
Population: ITT analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exufiber | Pain During Debridement | 25.8 mm | Standard Deviation 27.2 |
| Aquacel | Pain During Debridement | 26.9 mm | Standard Deviation 29 |
Secondary
Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features
Clinician reported outcomed by means a questionnaire was used to capture opinions related to the two dressing types. Reply alternatives varied between does not adhere, adhere a little, adhere a lot. Results reported as 'does not adhere' are presented as a percentage based on all follow-up visits aggregated.
Time frame: 6 weeks
Population: ITT analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exufiber | Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features | Non-adherence to wound bed at removal | 44.2 Percentage reported 'does not adhere' |
| Exufiber | Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features | Non-adherence to peri-wound skin at removal | 72.0 Percentage reported 'does not adhere' |
| Aquacel | Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features | Non-adherence to wound bed at removal | 31.1 Percentage reported 'does not adhere' |
| Aquacel | Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features | Non-adherence to peri-wound skin at removal | 52.1 Percentage reported 'does not adhere' |
Secondary
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features
Clinician reported outcomed by means a questionnaire was used to capture opinions related to the two dressing types. Reply alternatives varied between very poor, poor, good, very good. Results reported as 'very good' are presented as a percentage based on all follow-up visits aggregated.
Time frame: 6 weeks
Population: ITT analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exufiber | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ease of removal of dressing | 48.7 Percentage reported 'very good' |
| Exufiber | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ability to Absorb Exudates | 49.2 Percentage reported 'very good' |
| Exufiber | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Overall experience of dressing | 46 Percentage reported 'very good' |
| Exufiber | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ability to Retain Exudate | 47.8 Percentage reported 'very good' |
| Exufiber | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Flexibility of dressing | 48.0 Percentage reported 'very good' |
| Exufiber | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ability to Absorb Blood | 38.4 Percentage reported 'very good' |
| Exufiber | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Conformability to the wound | 39.9 Percentage reported 'very good' |
| Exufiber | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ability to Keep Blood and Slough | 36.3 Percentage reported 'very good' |
| Exufiber | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ease of application of dressing | 58.4 Percentage reported 'very good' |
| Aquacel | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ability to Keep Blood and Slough | 28.1 Percentage reported 'very good' |
| Aquacel | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ease of application of dressing | 57.5 Percentage reported 'very good' |
| Aquacel | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ease of removal of dressing | 35.9 Percentage reported 'very good' |
| Aquacel | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Flexibility of dressing | 40.8 Percentage reported 'very good' |
| Aquacel | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Overall experience of dressing | 32.5 Percentage reported 'very good' |
| Aquacel | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Conformability to the wound | 36.2 Percentage reported 'very good' |
| Aquacel | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ability to Absorb Exudates | 32.3 Percentage reported 'very good' |
| Aquacel | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ability to Retain Exudate | 31.7 Percentage reported 'very good' |
| Aquacel | Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Ability to Absorb Blood | 32.5 Percentage reported 'very good' |
Secondary
Wound Area Change (cm2)
The secondary endpoint was to measure relative reduction of wound area (cm2) from baseline to end of investigation (up to 6 weeks measured by the validated system PictZar on the photos taken after debridement at week 0, week 4, and week 6 (or final visit if healed earlier)
Time frame: 6 weeks
Population: ITT analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exufiber | Wound Area Change (cm2) | -4.64 relative wound area change in cm2 | Standard Deviation 7.73 |
| Aquacel | Wound Area Change (cm2) | -3.48 relative wound area change in cm2 | Standard Deviation 7.59 |
Other Pre-specified
Percentage of Participants With Healed Wounds
Wound healing assessments were based on blind independent clinical review of photos.
Time frame: from baseline to 24 weeks
Population: Subgroup followed until healing or up to 24 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exufiber | Percentage of Participants With Healed Wounds | 40.0 Percentage of participants |
| Aquacel | Percentage of Participants With Healed Wounds | 47.5 Percentage of participants |