Venous Leg Ulcers
Conditions
Keywords
venous leg ulcer, chronic leg ulcer, leg ulcer, skin substitute, high purity type-I collagen, dehydrated human amnion / chorion membrane
Brief summary
Venous leg ulcers are chronic wounds caused by venous insufficiency, leading to significant morbidity. The purpose of this randomized, controlled study is to evaluate the safety and efficacy of the application of Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM) in the treatment of VLUs and to compare their efficacy.
Detailed description
Venous leg ulcers (VLUs) are chronic wounds caused by venous insufficiency, leading to significant morbidity. Current treatment options often include compression therapy, wound debridement, and advanced dressings. Despite advances in wound care, effective treatment remains challenging. The purpose of this randomized, controlled study is to evaluate the safety and efficacy of the application of Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM) in the treatment of VLUs and to compare the efficacy of these two advanced wound care modalities in accelerating VLU healing.
Interventions
The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap
The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap
Sponsors
Dr Naveen Narayan MS, MCh (Plastic Surgery)
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. Subjects must have a diagnosis of a venous leg ulcer (confirmed by clinical and duplex ultrasound evaluation). 3. At enrolment subjects must have a target VLU with a minimum surface area of 2.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement using a ruler to measure wound area. 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit. 5. The target ulcer must be located on the foot, ankle and lower leg region. 6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone. 7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit: i. TCOM ≥30 mmHg ii. ABI between 0.7 and 1.3 iii. PVR: Biphasic iv. TBI ˃0.6 v. As an alternative arterial, Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity. h. 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. i. The subject must consent to using the prescribed off-loading method for the duration of the study. j. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol. k. The subject must be willing and able to participate in the informed consent process. l. Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histopathological Parameters - Collagen Deposition | 5 days | Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Masson's Trichrome for collagen assessment Collagen Deposition: Assessed using Masson's Trichrome staining (0-3 scale) 0: Minimal collagen matrix 1. Loose, immature collagen 2. Moderate organized collagen 3. Dense, mature collagen architecture (0-worse; 3-better) |
| Percentage Wound Area Change | 7 Weeks | Percentage wound area change from week 1 through week 7 measured manually with digital photography |
| Histopathological Parameters - Vascular Infiltration | 5 days | Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with Hematoxylin and Eosin (H&E) for general morphology. Vascular Infiltration: Assessed by counting new blood vessels per High Power Field (hpf) (0-3 scale) 0: Minimal vascular ingrowth (\<5 vessels/hpf) 1. Mild infiltration (5-10 vessels/hpf) 2. Moderate infiltration (11-20 vessels/hpf) 3. Abundant infiltration (\>20 vessels/hpf) (0-worse; 3-better) |
| Histopathological Parameters - Neo-epithelialization | 5 days | Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H&E) for general morphology. Neo-epithelialization: Measured as epithelial migration distance from wound edge (0-3 scale) 0: No epithelial migration 1. Minimal migration (\<25% wound coverage) 2. Moderate migration (25-75% coverage) 3. Extensive migration (\>75% coverage) (0-worse; 3-better) |
| Histopathological Parameters - Fibroblast Activity | 5 Days | Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: α-SMA immunohistochemistry for fibroblast activity. Fibroblast Activity: Quantified by counting α-SMA positive fibroblasts per HPF and assessment of fibroblast morphology (0-3 scale) 0: Sparse, inactive fibroblasts 1. Moderate cellularity, minimal matrix production 2. High cellularity, active-matrix synthesis 3. Very high activity with extensive matrix deposition (0-worse; 3-better) |
| Histopathological Parameters - Capillary Density | 5 days | Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: CD31 immunohistochemistry for capillary density evaluation Capillary Density: Evaluated using CD31 staining, counted as vessels per mm² of tissue |
| Histopathological Parameters - Inflammatory Response | 5 days | Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H&E) for general morphology Inflammatory Response: Graded semi-quantitatively (0-3 scale) 0: Minimal inflammatory infiltrate 1. Mild chronic inflammation 2. Moderate mixed inflammation 3. Severe acute inflammation (0-worse; 3-better) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Subjects to Obtain Complete Closure | 7 Weeks | The percentage of subjects that obtain complete closure over the 7 week treatment period |
| Number of Patients Requiring Repeated Application | 6 Weeks | Number of patients requiring repeated applications of the Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closure |
| Intervention Related Adverse Events | 6 Weeks | Number of participants with intervention related adverse events related to the intervention (e.g., infection, allergic reactions) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of Life | 7 weeks including 1-week follow-up | Change in quality of life assessed using the Wound-QoL questionnaire measured as 'not at all', 'a little', 'moderately', 'quite a lot' and 'very much' for 17 questions and total number of patients who reported improvement in Quality of Life was measured |
| Healed Wound Appearance Assessment Using Manchester Scar Scale | 7 weeks including 1-week follow-up | The resultant new skin is assessed and documented at each visit using the Manchester Scar Scale (MSS) assessing: 1. Colour: Perfect - 1, Slight mismatch - 2, Obvious mismatch - 3, Gross mismatch - 4 2. Finish: Matte - 1, Shiny - 2 3. Contour: Flush with surrounding skin - 1, Slightly proud / indented - 2, Hypertrophic - 3, Keloid - 4 4. Distortion: None -1, Mild - 2, Moderate - 3, Severe - 4 Lower score denotes a better outcome using the MSS (range: 4-14). In the study, scores were categorized as such: 1. Excellent: Scores 4 and 5 2. Good: Scores from 6 to 8 3. Fair: Scores from 9 to 11 4. Poor: Scores from 12 to 14 |
| Change in Pain | 7 weeks including 1-week follow-up | Change in pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0=no pain to 10=severe pain |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SOC and Type-I Collagen-based Skin Substitute The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing
SOC and Type-I Collagen-based Skin Substitute: The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap | 30 |
| SOC and Human Amnion/Chorion Membrane The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing
SOC and Human Amnion/Chorion Membrane: The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | SOC and Type-I Collagen-based Skin Substitute | Total | SOC and Human Amnion/Chorion Membrane |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 60 Participants | 30 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment India | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 10 Participants | 26 Participants | 16 Participants |
| Sex: Female, Male Male | 20 Participants | 34 Participants | 14 Participants |
| Ulcer duration | 2.13 Months STANDARD_DEVIATION 1.14 | 2.28 Months STANDARD_DEVIATION 1.21 | 2.43 Months STANDARD_DEVIATION 1.28 |
| Ulcer size | 14.84 square centimeters STANDARD_DEVIATION 1.87 | 15.02 square centimeters STANDARD_DEVIATION 1.89 | 15.19 square centimeters STANDARD_DEVIATION 1.91 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 2 / 30 | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Histopathological Parameters - Capillary Density
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: CD31 immunohistochemistry for capillary density evaluation Capillary Density: Evaluated using CD31 staining, counted as vessels per mm² of tissue
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Histopathological Parameters - Capillary Density | 47.3 number of vessels per mm² of tissue | Standard Deviation 8.2 |
| SOC and Human Amnion/Chorion Membrane | Histopathological Parameters - Capillary Density | 28.7 number of vessels per mm² of tissue | Standard Deviation 9.6 |
Primary
Histopathological Parameters - Collagen Deposition
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Masson's Trichrome for collagen assessment Collagen Deposition: Assessed using Masson's Trichrome staining (0-3 scale) 0: Minimal collagen matrix 1. Loose, immature collagen 2. Moderate organized collagen 3. Dense, mature collagen architecture (0-worse; 3-better)
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Histopathological Parameters - Collagen Deposition | 2.63 score on a scale (0-worse; 3-better) | Standard Deviation 0.49 |
| SOC and Human Amnion/Chorion Membrane | Histopathological Parameters - Collagen Deposition | 1.77 score on a scale (0-worse; 3-better) | Standard Deviation 0.63 |
Primary
Histopathological Parameters - Fibroblast Activity
Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: α-SMA immunohistochemistry for fibroblast activity. Fibroblast Activity: Quantified by counting α-SMA positive fibroblasts per HPF and assessment of fibroblast morphology (0-3 scale) 0: Sparse, inactive fibroblasts 1. Moderate cellularity, minimal matrix production 2. High cellularity, active-matrix synthesis 3. Very high activity with extensive matrix deposition (0-worse; 3-better)
Time frame: 5 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Histopathological Parameters - Fibroblast Activity | 2.80 score on a scale (0-worse; 3-better) | Standard Deviation 0.41 |
| SOC and Human Amnion/Chorion Membrane | Histopathological Parameters - Fibroblast Activity | 1.93 score on a scale (0-worse; 3-better) | Standard Deviation 0.64 |
Primary
Histopathological Parameters - Inflammatory Response
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H&E) for general morphology Inflammatory Response: Graded semi-quantitatively (0-3 scale) 0: Minimal inflammatory infiltrate 1. Mild chronic inflammation 2. Moderate mixed inflammation 3. Severe acute inflammation (0-worse; 3-better)
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Histopathological Parameters - Inflammatory Response | 1.23 score on a scale (0-worse; 3-better) | Standard Deviation 0.43 |
| SOC and Human Amnion/Chorion Membrane | Histopathological Parameters - Inflammatory Response | 2.17 score on a scale (0-worse; 3-better) | Standard Deviation 0.59 |
Primary
Histopathological Parameters - Neo-epithelialization
Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H&E) for general morphology. Neo-epithelialization: Measured as epithelial migration distance from wound edge (0-3 scale) 0: No epithelial migration 1. Minimal migration (\<25% wound coverage) 2. Moderate migration (25-75% coverage) 3. Extensive migration (\>75% coverage) (0-worse; 3-better)
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Histopathological Parameters - Neo-epithelialization | 2.67 score on a scale (0-worse; 3-better) | Standard Deviation 0.48 |
| SOC and Human Amnion/Chorion Membrane | Histopathological Parameters - Neo-epithelialization | 1.63 score on a scale (0-worse; 3-better) | Standard Deviation 0.72 |
Primary
Histopathological Parameters - Vascular Infiltration
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with Hematoxylin and Eosin (H&E) for general morphology. Vascular Infiltration: Assessed by counting new blood vessels per High Power Field (hpf) (0-3 scale) 0: Minimal vascular ingrowth (\<5 vessels/hpf) 1. Mild infiltration (5-10 vessels/hpf) 2. Moderate infiltration (11-20 vessels/hpf) 3. Abundant infiltration (\>20 vessels/hpf) (0-worse; 3-better)
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Histopathological Parameters - Vascular Infiltration | 2.73 score on a scale (0-worse; 3-better) | Standard Deviation 0.45 |
| SOC and Human Amnion/Chorion Membrane | Histopathological Parameters - Vascular Infiltration | 1.87 score on a scale (0-worse; 3-better) | Standard Deviation 0.68 |
Primary
Percentage Wound Area Change
Percentage wound area change from week 1 through week 7 measured manually with digital photography
Time frame: 7 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Percentage Wound Area Change | 78.9 percentage wound area reduction | Standard Deviation 17.8 |
| SOC and Human Amnion/Chorion Membrane | Percentage Wound Area Change | 65.4 percentage wound area reduction | Standard Deviation 7.9 |
Secondary
Intervention Related Adverse Events
Number of participants with intervention related adverse events related to the intervention (e.g., infection, allergic reactions)
Time frame: 6 Weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Intervention Related Adverse Events | No adverse event | 28 Participants |
| SOC and Type-I Collagen-based Skin Substitute | Intervention Related Adverse Events | Mild local reaction | 2 Participants |
| SOC and Type-I Collagen-based Skin Substitute | Intervention Related Adverse Events | Severe adverse events | 0 Participants |
| SOC and Human Amnion/Chorion Membrane | Intervention Related Adverse Events | No adverse event | 27 Participants |
| SOC and Human Amnion/Chorion Membrane | Intervention Related Adverse Events | Mild local reaction | 3 Participants |
| SOC and Human Amnion/Chorion Membrane | Intervention Related Adverse Events | Severe adverse events | 0 Participants |
Secondary
Number of Patients Requiring Repeated Application
Number of patients requiring repeated applications of the Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closure
Time frame: 6 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Number of Patients Requiring Repeated Application | 8 Participants |
| SOC and Human Amnion/Chorion Membrane | Number of Patients Requiring Repeated Application | 13 Participants |
Secondary
Percentage of Subjects to Obtain Complete Closure
The percentage of subjects that obtain complete closure over the 7 week treatment period
Time frame: 7 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Percentage of Subjects to Obtain Complete Closure | 21 Participants |
| SOC and Human Amnion/Chorion Membrane | Percentage of Subjects to Obtain Complete Closure | 13 Participants |
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 |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Time to Achieve Complete Wound Closure | 42.6 days | Standard Deviation 9.8 |
| SOC and Human Amnion/Chorion Membrane | Time to Achieve Complete Wound Closure | 46.2 days | Standard Deviation 8.7 |
Other Pre-specified
Change in Pain
Change in 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 including 1-week follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Change in Pain | Week 4 | 2.8 score on a scale | Standard Deviation 1.5 |
| SOC and Type-I Collagen-based Skin Substitute | Change in Pain | Week 1 | 2.9 score on a scale | Standard Deviation 1.5 |
| SOC and Type-I Collagen-based Skin Substitute | Change in Pain | Week 5 | 2.7 score on a scale | Standard Deviation 1.4 |
| SOC and Type-I Collagen-based Skin Substitute | Change in Pain | Week 6 | 2.8 score on a scale | Standard Deviation 1.6 |
| SOC and Type-I Collagen-based Skin Substitute | Change in Pain | Week 7 | 2.9 score on a scale | Standard Deviation 1.3 |
| SOC and Type-I Collagen-based Skin Substitute | Change in Pain | Week 2 | 3.7 score on a scale | Standard Deviation 1.3 |
| SOC and Type-I Collagen-based Skin Substitute | Change in Pain | Week 3 | 2.8 score on a scale | Standard Deviation 1.5 |
| SOC and Type-I Collagen-based Skin Substitute | Change in Pain | Week 0 | 4.9 score on a scale | Standard Deviation 1.7 |
| SOC and Human Amnion/Chorion Membrane | Change in Pain | Week 2 | 3.4 score on a scale | Standard Deviation 1.4 |
| SOC and Human Amnion/Chorion Membrane | Change in Pain | Week 0 | 4.6 score on a scale | Standard Deviation 1.5 |
| SOC and Human Amnion/Chorion Membrane | Change in Pain | Week 7 | 2.8 score on a scale | Standard Deviation 1.5 |
| SOC and Human Amnion/Chorion Membrane | Change in Pain | Week 4 | 3.2 score on a scale | Standard Deviation 1.5 |
| SOC and Human Amnion/Chorion Membrane | Change in Pain | Week 1 | 3.2 score on a scale | Standard Deviation 1.6 |
| SOC and Human Amnion/Chorion Membrane | Change in Pain | Week 5 | 2.8 score on a scale | Standard Deviation 1.2 |
| SOC and Human Amnion/Chorion Membrane | Change in Pain | Week 3 | 3.0 score on a scale | Standard Deviation 1.3 |
| SOC and Human Amnion/Chorion Membrane | Change in Pain | Week 6 | 3.0 score on a scale | Standard Deviation 1.4 |
Other Pre-specified
Healed Wound Appearance Assessment Using Manchester Scar Scale
The resultant new skin is assessed and documented at each visit using the Manchester Scar Scale (MSS) assessing: 1. Colour: Perfect - 1, Slight mismatch - 2, Obvious mismatch - 3, Gross mismatch - 4 2. Finish: Matte - 1, Shiny - 2 3. Contour: Flush with surrounding skin - 1, Slightly proud / indented - 2, Hypertrophic - 3, Keloid - 4 4. Distortion: None -1, Mild - 2, Moderate - 3, Severe - 4 Lower score denotes a better outcome using the MSS (range: 4-14). In the study, scores were categorized as such: 1. Excellent: Scores 4 and 5 2. Good: Scores from 6 to 8 3. Fair: Scores from 9 to 11 4. Poor: Scores from 12 to 14
Time frame: 7 weeks including 1-week follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Healed Wound Appearance Assessment Using Manchester Scar Scale | Good | 18 Participants |
| SOC and Type-I Collagen-based Skin Substitute | Healed Wound Appearance Assessment Using Manchester Scar Scale | Poor | 0 Participants |
| SOC and Type-I Collagen-based Skin Substitute | Healed Wound Appearance Assessment Using Manchester Scar Scale | Fair | 10 Participants |
| SOC and Type-I Collagen-based Skin Substitute | Healed Wound Appearance Assessment Using Manchester Scar Scale | Excellent | 2 Participants |
| SOC and Human Amnion/Chorion Membrane | Healed Wound Appearance Assessment Using Manchester Scar Scale | Excellent | 0 Participants |
| SOC and Human Amnion/Chorion Membrane | Healed Wound Appearance Assessment Using Manchester Scar Scale | Good | 11 Participants |
| SOC and Human Amnion/Chorion Membrane | Healed Wound Appearance Assessment Using Manchester Scar Scale | Fair | 14 Participants |
| SOC and Human Amnion/Chorion Membrane | Healed Wound Appearance Assessment Using Manchester Scar Scale | Poor | 5 Participants |
Other Pre-specified
Improvement in Quality of Life
Change in quality of life assessed using the Wound-QoL questionnaire measured as 'not at all', 'a little', 'moderately', 'quite a lot' and 'very much' for 17 questions and total number of patients who reported improvement in Quality of Life was measured
Time frame: 7 weeks including 1-week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Improvement in Quality of Life | 21 Participants |
| SOC and Human Amnion/Chorion Membrane | Improvement in Quality of Life | 12 Participants |