Multicentric RCT Comparing High Purity Type I Collagen-Skin Substitute vs dHACM in Treatment of Diabetic Foot Ulcers

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 5, 2025

Primary Completion Date

October 5, 2025

Study Completion Date

November 5, 2025

Conditions
Diabetic Foot Ulcer (DFU)
Interventions
DEVICE

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)

DEVICE

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)

Trial Locations (4)

560074

RECRUITING

RajaRajeswari Medical College and Hospital, Bangalore

570001

RECRUITING

Mysore Medical College and Research Institute, Mysore

570004

RECRUITING

JSS Medical College Hospital, Mysore

571448

RECRUITING

Adichunchanagiri Institute of Medical Sciences, Mandya

All Listed Sponsors
collaborator

Mysore Medical College and Research Institute

OTHER

collaborator

Rajarajeswari Dental College & Hospital

OTHER

collaborator

JSS Medical College Hospital

UNKNOWN

lead

Adichunchanagiri Institute of Medical Sciences, B G Nagara

OTHER

NCT07046403 - Multicentric RCT Comparing High Purity Type I Collagen-Skin Substitute vs dHACM in Treatment of Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter