High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs

NACompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

June 3, 2024

Primary Completion Date

September 15, 2024

Study Completion Date

September 30, 2024

Conditions
Diabetic Foot Ulcer (DFU)
Interventions
DEVICE

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)

OTHER

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)

Trial Locations (1)

571448

Adichunchanagiri Institute of Medical Sciences, Mandya

All Listed Sponsors
lead

Adichunchanagiri Institute of Medical Sciences, B G Nagara

OTHER

NCT06470087 - High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs | Biotech Hunter | Biotech Hunter