Trial Outcomes & Findings for Treatment of Pressure Ulcers Using Biological Skin Substitutes (NCT NCT06853210)

NCT ID: NCT06853210

Last Updated: 2025-08-29

Results Overview

Percent Change in Wound Area from week 1 through week 7 measured manually with digital photography

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 7 weeks
• Results posted on: 2025-08-29

Participant Flow

Participant milestones

Measure	High Purity 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
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 n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=80 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=40 Participants	19 Participants n=40 Participants	41 Participants n=80 Participants
Age, Categorical >=65 years	18 Participants n=40 Participants	21 Participants n=40 Participants	39 Participants n=80 Participants
Sex: Female, Male Female	12 Participants n=40 Participants	18 Participants n=40 Participants	30 Participants n=80 Participants
Sex: Female, Male Male	28 Participants n=40 Participants	22 Participants n=40 Participants	50 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment India	40 Participants n=40 Participants	40 Participants n=40 Participants	80 Participants n=80 Participants
Ulcer duration	2.1 Months STANDARD_DEVIATION 1.1 • n=40 Participants	2.3 Months STANDARD_DEVIATION 1.2 • n=40 Participants	2.2 Months STANDARD_DEVIATION 1.15 • n=80 Participants
Ulcer size	14.9 square centimeters STANDARD_DEVIATION 2.1 • n=40 Participants	15.0 square centimeters STANDARD_DEVIATION 1.8 • n=40 Participants	14.95 square centimeters STANDARD_DEVIATION 1.94 • n=80 Participants
Ulcer Location Distribution Gluteal region	16 Participants n=40 Participants	16 Participants n=40 Participants	32 Participants n=80 Participants
Ulcer Location Distribution Sacral region	11 Participants n=40 Participants	12 Participants n=40 Participants	23 Participants n=80 Participants
Ulcer Location Distribution Lateral malleolus	5 Participants n=40 Participants	6 Participants n=40 Participants	11 Participants n=80 Participants
Ulcer Location Distribution Heel	6 Participants n=40 Participants	4 Participants n=40 Participants	10 Participants n=80 Participants
Ulcer Location Distribution Elbow	2 Participants n=40 Participants	2 Participants n=40 Participants	4 Participants n=80 Participants

PRIMARY outcome

Timeframe: 7 weeks

Percent Change in Wound Area from week 1 through week 7 measured manually with digital photography

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Percent Change in Wound Area	-78.5 percentage change Standard Deviation 18.2	-65.1 percentage change Standard Deviation 9.8

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 5

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	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Histopathological Parameters - Vascular Infiltration Day 0 / Baseline · Grade 0	11 Participants	17 Participants
Histopathological Parameters - Vascular Infiltration Day 0 / Baseline · Grade 1	15 Participants	14 Participants
Histopathological Parameters - Vascular Infiltration Day 0 / Baseline · Grade 2	8 Participants	6 Participants
Histopathological Parameters - Vascular Infiltration Day 0 / Baseline · Grade 3	6 Participants	3 Participants
Histopathological Parameters - Vascular Infiltration Day 5 Post Application · Grade 0	0 Participants	4 Participants
Histopathological Parameters - Vascular Infiltration Day 5 Post Application · Grade 1	2 Participants	13 Participants
Histopathological Parameters - Vascular Infiltration Day 5 Post Application · Grade 2	7 Participants	15 Participants
Histopathological Parameters - Vascular Infiltration Day 5 Post Application · Grade 3	31 Participants	8 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 5

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	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Histopathological Parameters - Neo-epithelialization Day 0 / Baseline · Grade 0	18 Participants	24 Participants
Histopathological Parameters - Neo-epithelialization Day 0 / Baseline · Grade 1	12 Participants	10 Participants
Histopathological Parameters - Neo-epithelialization Day 0 / Baseline · Grade 2	7 Participants	4 Participants
Histopathological Parameters - Neo-epithelialization Day 0 / Baseline · Grade 3	3 Participants	2 Participants
Histopathological Parameters - Neo-epithelialization Day 5 of Post Application · Grade 0	0 Participants	6 Participants
Histopathological Parameters - Neo-epithelialization Day 5 of Post Application · Grade 1	4 Participants	15 Participants
Histopathological Parameters - Neo-epithelialization Day 5 of Post Application · Grade 2	8 Participants	10 Participants
Histopathological Parameters - Neo-epithelialization Day 5 of Post Application · Grade 3	28 Participants	9 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 5

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	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Histopathological Parameters - Fibroblast Activity Day 0 / Baseline · Grade 0	7 Participants	12 Participants
Histopathological Parameters - Fibroblast Activity Day 0 / Baseline · Grade 1	17 Participants	16 Participants
Histopathological Parameters - Fibroblast Activity Day 0 / Baseline · Grade 2	13 Participants	10 Participants
Histopathological Parameters - Fibroblast Activity Day 0 / Baseline · Grade 3	3 Participants	2 Participants
Histopathological Parameters - Fibroblast Activity Day 5 Post Application · Grade 0	0 Participants	3 Participants
Histopathological Parameters - Fibroblast Activity Day 5 Post Application · Grade 1	2 Participants	15 Participants
Histopathological Parameters - Fibroblast Activity Day 5 Post Application · Grade 2	5 Participants	15 Participants
Histopathological Parameters - Fibroblast Activity Day 5 Post Application · Grade 3	33 Participants	7 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 5

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-better; 3-worse)

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Histopathological Parameters - Inflammatory Response Day 0 / Baseline · Grade 0	21 Participants	12 Participants
Histopathological Parameters - Inflammatory Response Day 0 / Baseline · Grade 1	14 Participants	16 Participants
Histopathological Parameters - Inflammatory Response Day 0 / Baseline · Grade 2	5 Participants	11 Participants
Histopathological Parameters - Inflammatory Response Day 0 / Baseline · Grade 3	0 Participants	1 Participants
Histopathological Parameters - Inflammatory Response Day 5 Post Application · Grade 0	20 Participants	9 Participants
Histopathological Parameters - Inflammatory Response Day 5 Post Application · Grade 1	17 Participants	12 Participants
Histopathological Parameters - Inflammatory Response Day 5 Post Application · Grade 2	3 Participants	15 Participants
Histopathological Parameters - Inflammatory Response Day 5 Post Application · Grade 3	0 Participants	4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 5

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

More the vessels per square centimeters better

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Histopathological Parameters - Capillary Density	47.3 vessels per square centimeters Standard Deviation 8.2	28.7 vessels per square centimeters Standard Deviation 9.6

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 5

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	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Histopathological Parameters - Collagen Deposition	2.63 score on a scale Standard Deviation 0.49	1.77 score on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: 7 weeks

Percentage of subjects to obtain complete closure, defined as 100% epithelialization with no drainage, of the target ulcer was determined by the proportion of subjects that obtain complete closure over the 6-week treatment period and additional 1 week follow up

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Complete Wound Closure Rates	30 Participants	25 Participants

SECONDARY outcome

Timeframe: 6 weeks

Mean wound sizes at each time point for both treatment groups assessing change in wound size throughout the study period. Assessed from baseline, through day 5, 14th day, 21 st day, 28th, 35th and 42nd days of HPTC or dHACM application

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Wound Size Progression Over Time Baseline	14.9 sqauare centimeters Standard Deviation 2.1	15.0 sqauare centimeters Standard Deviation 1.8
Wound Size Progression Over Time Day 28	7.0 sqauare centimeters Standard Deviation 3.1	8.2 sqauare centimeters Standard Deviation 2.4
Wound Size Progression Over Time Day 35	5.2 sqauare centimeters Standard Deviation 3.2	6.8 sqauare centimeters Standard Deviation 2.6
Wound Size Progression Over Time Day 42	3.2 sqauare centimeters Standard Deviation 3.1	5.2 sqauare centimeters Standard Deviation 2.4
Wound Size Progression Over Time Day 5	13.1 sqauare centimeters Standard Deviation 2.3	13.4 sqauare centimeters Standard Deviation 2.1
Wound Size Progression Over Time Day 14	11.1 sqauare centimeters Standard Deviation 2.4	11.5 sqauare centimeters Standard Deviation 2.2
Wound Size Progression Over Time Day 21	9.1 sqauare centimeters Standard Deviation 2.8	9.8 sqauare centimeters Standard Deviation 2.1

SECONDARY outcome

Timeframe: 6 weeks

Mean number of reapplications of the HPTC & dHACM used to obtain wound closure over 6 Weeks

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Mean Number of Repeated Application	0.85 mean number of reapplications Standard Deviation 0.92	1.15 mean number of reapplications Standard Deviation 0.87

SECONDARY outcome

Timeframe: 6 weeks

Adverse events (e.g., infection, allergic reactions)

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Adverse Events No adverse event	38 Participants	34 Participants
Adverse Events Mild Erythema	2 Participants	4 Participants
Adverse Events Mild Allergic Reaction	0 Participants	2 Participants
Adverse Events Severe adverse events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 7 weeks

Patient treatment satisfaction will be assessed by using a validated 5-point Likert scale questionnaire administered at 7 weeks post-treatment initiation. The questionnaire evaluated overall treatment satisfaction, comfort during application, perceived effectiveness, and willingness to recommend the treatment to others, measured with score range from 1 to 5, wherein 1="Extremally Unsatisfied" to 5="Extremally Satisfied"

Outcome measures

Measure	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Patient Treatment Satisfaction	4.33 score on a scale Standard Deviation 0.62	3.41 score on a scale Standard Deviation 0.78

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 weeks

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	High Purity Type-I Collagen-based Skin Substitute n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 Participants The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Change in Quality of Life Improvement	29 Participants	17 Participants
Change in Quality of Life No Change	11 Participants	19 Participants
Change in Quality of Life Worsening	0 Participants	4 Participants

Adverse Events

High Purity Type-I Collagen-based Skin Substitute

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dehydrated Human Amnion/Chorion Membrane

Serious events: 0 serious events

Other events: 6 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 n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Dehydrated Human Amnion/Chorion Membrane n=40 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 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
Immune system disorders Mild Erythema	5.0% 2/40 • Number of events 2 • 7 weeks All the study participants were considered at risk for adverse events.	10.0% 4/40 • Number of events 4 • 7 weeks All the study participants were considered at risk for adverse events.
Immune system disorders Mild Allergic Reaction	0.00% 0/40 • 7 weeks All the study participants were considered at risk for adverse events.	5.0% 2/40 • Number of events 2 • 7 weeks 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