NCT06470087

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

A Randomized Controlled Clinical Trial Comparing High Purity Type-I Collagen-based Skin Substitute to Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and Standard of Care with Dehydrated Human Amnion/Chorion Membrane.

Detailed description

The purpose of this randomized controlled clinical study is to collect and compare patient outcome data at 4 weeks using Type-I Collagen-based Skin Substitute in one half of the patients and Dehydrated Human Amnion/Chorion Membrane in the other half.

Conditions

• Diabetic Foot Ulcer (DFU)

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-06-03
• Primary completion: 2024-09-15
• Completion: 2024-09-30
• First posted: 2024-06-24
• Last updated: 2025-11-14
• Results posted: 2025-01-06

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated device study