Trial Outcomes & Findings for High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs (NCT NCT06470087)

NCT ID: NCT06470087

Last Updated: 2025-11-10

Results Overview

Change in wound area reduction from week 1 through 4 measured manually with digital photography

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	SOC and Type-I Collagen-based Skin Substitute Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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)	SOC and Human Amnion/Chorion Membrane Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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	14	14
Overall Study COMPLETED	14	14
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

Baseline characteristics by cohort
Measure	SOC and Type-I Collagen-based Skin Substitute n=14 Participants Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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)	SOC and Human Amnion/Chorion Membrane n=14 Participants Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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=28 Participants Total of all reporting groups
Age, Continuous	49.4 years STANDARD_DEVIATION 5.98 • n=14 Participants	52.3 years STANDARD_DEVIATION 7.16 • n=14 Participants	50.9 years STANDARD_DEVIATION 6.63 • n=28 Participants
Sex: Female, Male Female	3 Participants n=14 Participants	3 Participants n=14 Participants	6 Participants n=28 Participants
Sex: Female, Male Male	11 Participants n=14 Participants	11 Participants n=14 Participants	22 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	25.4 kg/m^2 STANDARD_DEVIATION 2.28 • n=14 Participants	25.3 kg/m^2 STANDARD_DEVIATION 2.08 • n=14 Participants	25.4 kg/m^2 STANDARD_DEVIATION 2.11 • n=28 Participants
Smoking Smoking (Present)	3 Participants n=14 Participants	3 Participants n=14 Participants	6 Participants n=28 Participants
Smoking Smoking (Absent)	11 Participants n=14 Participants	11 Participants n=14 Participants	22 Participants n=28 Participants
Hypertension Hypertension (Present)	2 Participants n=14 Participants	3 Participants n=14 Participants	5 Participants n=28 Participants
Hypertension Hypertension (Absent)	12 Participants n=14 Participants	11 Participants n=14 Participants	23 Participants n=28 Participants
Doppler Scan Findings Biphasic Flow	4 Participants n=14 Participants	5 Participants n=14 Participants	9 Participants n=28 Participants
Doppler Scan Findings Triphasic Flow	10 Participants n=14 Participants	9 Participants n=14 Participants	19 Participants n=28 Participants
Glcosylated Hemoglobin	5.8 mmol/mol STANDARD_DEVIATION 0.27 • n=14 Participants	5.8 mmol/mol STANDARD_DEVIATION 0.25 • n=14 Participants	5.8 mmol/mol STANDARD_DEVIATION 0.25 • n=28 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: The number given indicates the average change in wound area in both the groups between baseline and week 4. Since in all the study participants the wound area has decreased, the value in the table indicates average decrease in wound area in both the groups.

Change in wound area reduction from week 1 through 4 measured manually with digital photography

Outcome measures

Outcome measures
Measure	SOC and Type-I Collagen-based Skin Substitute n=14 Participants Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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)	SOC and Human Amnion/Chorion Membrane n=14 Participants Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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)
Change in Wound Area From Week 1 Through 4	93.62 percentage wound area reduction Standard Deviation 0.12	77.71 percentage wound area reduction Standard Deviation 0.28

SECONDARY outcome

Timeframe: 4 weeks

The proportion of subjects that obtain complete closure over the 4-week treatment period

Outcome measures

Outcome measures
Measure	SOC and Type-I Collagen-based Skin Substitute n=14 Participants Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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)	SOC and Human Amnion/Chorion Membrane n=14 Participants Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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)
Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period	10 Participants	7 Participants

SECONDARY outcome

Timeframe: 4 Weeks

Percenatge of participants undergoing repeat applications of Advanced Skin Substitute \& Human Amnion/Chorion Membrane used to obtain wound closure. Since the participants who underwent repeat applications in both groups had only one repeat application, instead of the mean number of repeat applications we are indicating the percentage of participants having repeat applications in both the groups.

Outcome measures

Outcome measures
Measure	SOC and Type-I Collagen-based Skin Substitute n=14 Participants Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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)	SOC and Human Amnion/Chorion Membrane n=14 Participants Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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)
Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure	5 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: The appearance of thewound was assessed only once i.e at the end of 5th week.

Visual observation of the newly formed skin for signs of redness, swelling and other abnormalities. Appearance was assessed using visual analog scale, wherein the scale ratings ranged from 0 to 5 where 0 refers to worst appearance and 5 refers to best appearance

Outcome measures

Outcome measures
Measure	SOC and Type-I Collagen-based Skin Substitute n=14 Participants Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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)	SOC and Human Amnion/Chorion Membrane n=14 Participants Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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)
Appearance	2.5 units on a scale Standard Deviation 0.52	2.2 units on a scale Standard Deviation 0.69

OTHER_PRE_SPECIFIED outcome

Timeframe: The appearance of the woundd was assessed only once i.e. at the end of 5th week.

Structural stability of the healed wound will be assessed by compression testing using a blunt-edged tool. Following assessment by the blunt tool, structural stability was rated on 5 point visual anaog scale, where 1 represents fragile and 5 represents stable wound

Outcome measures

Outcome measures
Measure	SOC and Type-I Collagen-based Skin Substitute n=14 Participants Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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)	SOC and Human Amnion/Chorion Membrane n=14 Participants Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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)
Structural Stability of the Scar	3.43 units on a scale Standard Deviation 1.02	2.71 units on a scale Standard Deviation 0.91

OTHER_PRE_SPECIFIED outcome

Timeframe: During 1-week follow-up

Subject will be observed for any recurrence of the wound after its closure during the 1-week follow-up

Outcome measures

Outcome measures
Measure	SOC and Type-I Collagen-based Skin Substitute n=14 Participants Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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)	SOC and Human Amnion/Chorion Membrane n=14 Participants Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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)
Wound Recurrence	1 Participants	2 Participants

Adverse Events

SOC and Type-I Collagen-based Skin Substitute

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SOC and Human Amnion/Chorion Membrane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Naveen N

Adichunchanagiri Institute of Medical Sciences, BG Nagara

Phone: 9980023372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place