A RCT Evaluating Efficacy of Type-I Collagen Skin Substitute vs. Human Amnion Membrane in Treatment of Venous Leg Ulcers

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

June 30, 2025

Study Completion Date

July 10, 2025

Conditions
Venous Leg Ulcers
Interventions
DEVICE

SOC and 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 comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap

DEVICE

SOC and 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 comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap

Trial Locations (1)

571448

Adichunchanagiri Institute of Medical Sciences, Mandya

All Listed Sponsors
lead

Dr Naveen Narayan MS, MCh (Plastic Surgery)

OTHER

NCT06831760 - A RCT Evaluating Efficacy of Type-I Collagen Skin Substitute vs. Human Amnion Membrane in Treatment of Venous Leg Ulcers | Biotech Hunter | Biotech Hunter