Trial Outcomes & Findings for A RCT Evaluating Efficacy of Type-I Collagen Skin Substitute vs. Human Amnion Membrane in Treatment of Venous Leg Ulcers (NCT NCT06831760)

NCT ID: NCT06831760

Last Updated: 2025-09-22

Results Overview

Percentage wound area change from week 1 through week 7 measured manually with digital photography

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 7 Weeks
• Results posted on: 2025-09-22

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Sex: Female, Male Female	10 Participants n=30 Participants	16 Participants n=30 Participants	26 Participants n=60 Participants
Sex: Female, Male Male	20 Participants n=30 Participants	14 Participants n=30 Participants	34 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment India	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
Ulcer duration	2.13 Months STANDARD_DEVIATION 1.14 • n=30 Participants	2.43 Months STANDARD_DEVIATION 1.28 • n=30 Participants	2.28 Months STANDARD_DEVIATION 1.21 • n=60 Participants
Ulcer size	14.84 square centimeters STANDARD_DEVIATION 1.87 • n=30 Participants	15.19 square centimeters STANDARD_DEVIATION 1.91 • n=30 Participants	15.02 square centimeters STANDARD_DEVIATION 1.89 • n=60 Participants

PRIMARY outcome

Timeframe: 7 Weeks

Percentage wound area change from week 1 through week 7 measured manually with digital photography

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Percentage Wound Area Change	78.9 percentage wound area reduction Standard Deviation 17.8	65.4 percentage wound area reduction Standard Deviation 7.9

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Histopathological Parameters - Vascular Infiltration	2.73 score on a scale (0-worse; 3-better) Standard Deviation 0.45	1.87 score on a scale (0-worse; 3-better) Standard Deviation 0.68

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Histopathological Parameters - Neo-epithelialization	2.67 score on a scale (0-worse; 3-better) Standard Deviation 0.48	1.63 score on a scale (0-worse; 3-better) Standard Deviation 0.72

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Histopathological Parameters - Fibroblast Activity	2.80 score on a scale (0-worse; 3-better) Standard Deviation 0.41	1.93 score on a scale (0-worse; 3-better) Standard Deviation 0.64

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Histopathological Parameters - Capillary Density	47.3 number of vessels per mm² of tissue Standard Deviation 8.2	28.7 number of vessels per mm² of tissue Standard Deviation 9.6

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Histopathological Parameters - Inflammatory Response	1.23 score on a scale (0-worse; 3-better) Standard Deviation 0.43	2.17 score on a scale (0-worse; 3-better) Standard Deviation 0.59

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Histopathological Parameters - Collagen Deposition	2.63 score on a scale (0-worse; 3-better) Standard Deviation 0.49	1.77 score on a scale (0-worse; 3-better) Standard Deviation 0.63

SECONDARY outcome

Timeframe: 7 weeks

The time to achieve complete wound closure of the target ulcer by the end of 7 weeks

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Time to Achieve Complete Wound Closure	42.6 days Standard Deviation 9.8	46.2 days Standard Deviation 8.7

SECONDARY outcome

Timeframe: 7 Weeks

The percentage of subjects that obtain complete closure over the 7 week treatment period

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Percentage of Subjects to Obtain Complete Closure	21 Participants	13 Participants

SECONDARY outcome

Timeframe: 6 Weeks

Number of patients requiring repeated applications of the Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closure

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Number of Patients Requiring Repeated Application	8 Participants	13 Participants

SECONDARY outcome

Timeframe: 6 Weeks

Number of participants with intervention related adverse events related to the intervention (e.g., infection, allergic reactions)

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Intervention Related Adverse Events No adverse event	28 Participants	27 Participants
Intervention Related Adverse Events Mild local reaction	2 Participants	3 Participants
Intervention Related Adverse Events Severe adverse events	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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"

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Change in Pain Week 0	4.9 score on a scale Standard Deviation 1.7	4.6 score on a scale Standard Deviation 1.5
Change in Pain Week 1	2.9 score on a scale Standard Deviation 1.5	3.2 score on a scale Standard Deviation 1.6
Change in Pain Week 2	3.7 score on a scale Standard Deviation 1.3	3.4 score on a scale Standard Deviation 1.4
Change in Pain Week 3	2.8 score on a scale Standard Deviation 1.5	3.0 score on a scale Standard Deviation 1.3
Change in Pain Week 4	2.8 score on a scale Standard Deviation 1.5	3.2 score on a scale Standard Deviation 1.5
Change in Pain Week 5	2.7 score on a scale Standard Deviation 1.4	2.8 score on a scale Standard Deviation 1.2
Change in Pain Week 6	2.8 score on a scale Standard Deviation 1.6	3.0 score on a scale Standard Deviation 1.4
Change in Pain Week 7	2.9 score on a scale Standard Deviation 1.3	2.8 score on a scale Standard Deviation 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Improvement in Quality of Life	21 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 Participants 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	SOC and Human Amnion/Chorion Membrane n=30 Participants 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
Healed Wound Appearance Assessment Using Manchester Scar Scale Excellent	2 Participants	0 Participants
Healed Wound Appearance Assessment Using Manchester Scar Scale Good	18 Participants	11 Participants
Healed Wound Appearance Assessment Using Manchester Scar Scale Fair	10 Participants	14 Participants
Healed Wound Appearance Assessment Using Manchester Scar Scale Poor	0 Participants	5 Participants

Adverse Events

SOC and Type-I Collagen-based Skin Substitute

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

SOC and Human Amnion/Chorion Membrane

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SOC and Type-I Collagen-based Skin Substitute n=30 participants at risk 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	SOC and Human Amnion/Chorion Membrane n=30 participants at risk 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
Infections and infestations Infections	0.00% 0/30 • 7 Weeks including 1 week follow up All the study participants were considered at risk for adverse events.	0.00% 0/30 • 7 Weeks including 1 week follow up All the study participants were considered at risk for adverse events.
Immune system disorders Mild local reaction	6.7% 2/30 • 7 Weeks including 1 week follow up All the study participants were considered at risk for adverse events.	10.0% 3/30 • 7 Weeks including 1 week follow up All the study participants were considered at risk for adverse events.

Additional Information

Dr Naveen N

Adichunchanagiri Institute of Medical Sciences

Phone: +91-9980023372

Email: naveen_uno1@yahoo.co.in

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place