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

NCT07046403 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-11-21

Study results available
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Summary

This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centers. 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.

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)

Sponsors & Collaborators

  • Mysore Medical College and Research Institute

    collaborator OTHER

  • Rajarajeswari Dental College & Hospital

    collaborator OTHER

  • JSS Medical College Hospital

    collaborator UNKNOWN

  • Adichunchanagiri Institute of Medical Sciences, B G Nagara

    lead OTHER

Principal Investigators

  • Prema Dhanraj, MS, MCh · Rajarajeshwari Medical College and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-05
Primary Completion
2025-09-09
Completion
2025-10-03
FDA Device
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046403 on ClinicalTrials.gov