Trial Outcomes & Findings for Multicentric RCT Comparing High Purity Type I Collagen-Skin Substitute vs dHACM in Treatment of Diabetic Foot Ulcers (NCT NCT07046403)

NCT ID: NCT07046403

Last Updated: 2025-11-21

Results Overview

The primary outcome of the study will be the percentage change in wound area, assessed at 1, 2,3, and 4 weeks, and week 5 reported measured manually with digital photography.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2025-11-21

Participant Flow

Participant milestones

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
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	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Total n=120 Participants Total of all reporting groups
Age, Continuous	52.4 years STANDARD_DEVIATION 8.2 • n=60 Participants	53.1 years STANDARD_DEVIATION 9.1 • n=60 Participants	52.75 years STANDARD_DEVIATION 8.62 • n=120 Participants
Sex: Female, Male Female	18 Participants n=60 Participants	22 Participants n=60 Participants	40 Participants n=120 Participants
Sex: Female, Male Male	42 Participants n=60 Participants	38 Participants n=60 Participants	80 Participants n=120 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment India	60 participants n=60 Participants	60 participants n=60 Participants	120 participants n=120 Participants
BMI (kg/m²)	26.8 kg/m^2 STANDARD_DEVIATION 3.4 • n=60 Participants	26.2 kg/m^2 STANDARD_DEVIATION 3.8 • n=60 Participants	26.5 kg/m^2 STANDARD_DEVIATION 3.6 • n=120 Participants
Diabetes duration (years)	12.6 years STANDARD_DEVIATION 5.8 • n=60 Participants	13.2 years STANDARD_DEVIATION 6.4 • n=60 Participants	12.9 years STANDARD_DEVIATION 6.1 • n=120 Participants
HbA1c (as percentage)	8.4 percentage of HbA1c STANDARD_DEVIATION 1.6 • n=60 Participants	8.7 percentage of HbA1c STANDARD_DEVIATION 1.8 • n=60 Participants	8.6 percentage of HbA1c STANDARD_DEVIATION 1.7 • n=120 Participants
Ulcer duration (weeks)	8.4 weeks STANDARD_DEVIATION 4.2 • n=60 Participants	8.9 weeks STANDARD_DEVIATION 4.6 • n=60 Participants	8.7 weeks STANDARD_DEVIATION 4.4 • n=120 Participants
Ulcer size (cm²)	10.4 square centimeters STANDARD_DEVIATION 3.2 • n=60 Participants	9.8 square centimeters STANDARD_DEVIATION 2.9 • n=60 Participants	10.1 square centimeters STANDARD_DEVIATION 3.1 • n=120 Participants
Ankle-Brachial Index (ABI)	0.94 ratio STANDARD_DEVIATION 0.18 • n=60 Participants	0.91 ratio STANDARD_DEVIATION 0.16 • n=60 Participants	0.93 ratio STANDARD_DEVIATION 0.17 • n=120 Participants
Previous ulcer history	18 Participants n=60 Participants	22 Participants n=60 Participants	40 Participants n=120 Participants

PRIMARY outcome

Timeframe: 5 weeks

The primary outcome of the study will be the percentage change in wound area, assessed at 1, 2,3, and 4 weeks, and week 5 reported measured manually with digital photography.

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Percentage Change in Wound Area	81.5 percentage change Standard Deviation 12.3	64.2 percentage change Standard Deviation 14.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Histopathological Analysis vascular infiltration (0-3 scale)	2.4 score on a scale Standard Deviation 0.6	1.8 score on a scale Standard Deviation 0.7
Histopathological Analysis neo-epithelialization (0-3 scale)	2.6 score on a scale Standard Deviation 0.5	2.1 score on a scale Standard Deviation 0.6
Histopathological Analysis fibroblast activity (0-3 scale)	2.5 score on a scale Standard Deviation 0.6	1.9 score on a scale Standard Deviation 0.7
Histopathological Analysis inflammatory response (0-3 scale)	1.2 score on a scale Standard Deviation 0.4	1.8 score on a scale Standard Deviation 0.6
Histopathological Analysis collagen deposition (0-3 scale)	2.3 score on a scale Standard Deviation 0.7	1.7 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Histopathological Analysis - Capillary Density (Vessels Per mm²)	45.6 vessels per mm² Standard Deviation 7.9	29.4 vessels per mm² Standard Deviation 9.2

SECONDARY outcome

Timeframe: 5 weeks

The percentage of participants that obtain complete wound closure over the 5 weeks (4 weeks treatment period plus 1 week follow up)

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Percentage of Participants to Obtain Complete Wound Closure	50 Participants	31 Participants

SECONDARY outcome

Timeframe: 5 weeks

Complete wound closure is defined as full epithelialization of the wound with no need for dressings, and sustained closure without signs of infection or breakdown.Time taken for the target ulcer to achieve this will be assessed on days 7, 14, 21, 28 and 35.

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Time to Achieve Complete Wound Closure	22.2 days Standard Deviation 5.4	28.8 days Standard Deviation 6.2

SECONDARY outcome

Timeframe: 5 weeks

Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Percentage of Participants Achieving ≥50% Wound Healing	53 Participants	33 Participants

SECONDARY outcome

Timeframe: 4 weeks

The average number of applications of High Purity Type-I Collagen-based Skin Substitute (HPTC) or dehydrated human amniotic/chorionic membrane (dHACM) to achieve wound closure will be documented as part of the study process.

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Mean Number of Applications of HPTC / dHACM	2.8 number of applications Standard Deviation 1.2	3.4 number of applications Standard Deviation 1.6

SECONDARY outcome

Timeframe: 4 weeks

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

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Number of Participants With Adverse Events	4 Participants	11 Participants

SECONDARY outcome

Timeframe: 5 weeks

The Diabetic Foot Ulcer Scale - Short Form (DFS-SF) is a validated, disease-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of diabetic foot ulcers on patients' wellbeing evaluating four validated sub-scales:

Physical Functioning Daily Activities Emotions Social Functioning

Subscale Scoring: Scores range from 0-100 for each sub-scale, with higher scores indicating better quality of life. Data were collected at baseline and at Weeks 2, 4, and 5, and week 5 results reported

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Patient-Reported Quality of Life Assessed Using Diabetic Foot Ulcer Scale - Short Form (DFS-SF) Physical functioning	78.6 Scores on a scale (0-100) Standard Deviation 14.2	68.4 Scores on a scale (0-100) Standard Deviation 16.8
Patient-Reported Quality of Life Assessed Using Diabetic Foot Ulcer Scale - Short Form (DFS-SF) Daily activities	76.2 Scores on a scale (0-100) Standard Deviation 13.6	62.8 Scores on a scale (0-100) Standard Deviation 15.4
Patient-Reported Quality of Life Assessed Using Diabetic Foot Ulcer Scale - Short Form (DFS-SF) Emotions	82.4 Scores on a scale (0-100) Standard Deviation 12.8	71.6 Scores on a scale (0-100) Standard Deviation 16.2
Patient-Reported Quality of Life Assessed Using Diabetic Foot Ulcer Scale - Short Form (DFS-SF) Social functioning	79.8 Scores on a scale (0-100) Standard Deviation 15.2	65.2 Scores on a scale (0-100) Standard Deviation 17.6

SECONDARY outcome

Timeframe: 5 weeks

The resultant new skin is assessed and documented at each visit up to 5 weeks and week 5 visit reported using the Vancouver Scar Scale assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar)

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 Participants 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Healed Wound Appearance Assessment Using Vancouver Scar Scale	4.2 scores on a scale (0-13) Standard Deviation 2.1	6.8 scores on a scale (0-13) Standard Deviation 2.8

Adverse Events

High Purity Type-I Collagen-based Skin Substitute and SOC

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Human Amnion/Chorion Membrane and SOC

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	High Purity Type-I Collagen-based Skin Substitute and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)	Human Amnion/Chorion Membrane and SOC n=60 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 comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)
Skin and subcutaneous tissue disorders Local irritation	1.7% 1/60 • 5 weeks - From first application (Week 0) through end of follow-up (Week 5). All the study participants were considered at risk for adverse events.	5.0% 3/60 • 5 weeks - From first application (Week 0) through end of follow-up (Week 5). All the study participants were considered at risk for adverse events.
Skin and subcutaneous tissue disorders Minor allergy	1.7% 1/60 • 5 weeks - From first application (Week 0) through end of follow-up (Week 5). All the study participants were considered at risk for adverse events.	6.7% 4/60 • 5 weeks - From first application (Week 0) through end of follow-up (Week 5). All the study participants were considered at risk for adverse events.
Skin and subcutaneous tissue disorders Mild infection	3.3% 2/60 • 5 weeks - From first application (Week 0) through end of follow-up (Week 5). All the study participants were considered at risk for adverse events.	6.7% 4/60 • 5 weeks - From first application (Week 0) through end of follow-up (Week 5). 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