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HPTC Versus AFSM in Diabetic Foot Ulcers

NCT07781917 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-24

No results posted yet for this study

Summary

This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centres in India and Bangladesh. The study compares patient outcomes using standard wound care with a High Purity Type-I Collagen-Based Skin Substitute against standard wound care with an Acellular Intact Fish Skin Matrix.

Conditions

  • Diabetic Foot Ulcer (DFU)

Interventions

DEVICE

High Purity Type-I Collagen-Based Skin Substitute and SOC

Arm A - The SOC in this study is wound care covering with High Purity Type-I Collagen-Based Skin Substitute (Helicoll®) applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze, second layer - absorbent gauze pads \& third layer - soft roll and compressive wrap (crepe bandage). For participants enrolled in the optional histopathological sub-study, a 2-mm punch biopsy will be obtained from the wound edge at baseline and on Day 5 under local anesthesia. Specimens will be fixed in 10% neutral buffered formalin, paraffin-embedded, and sectioned at 4 μm for histological and immunohistochemical analysis.

DEVICE

Acellular Intact Fish Skin Matrix and SOC

Arm B - The SOC in this study is wound care covering with Acellular Intact Fish Skin Matrix (Kerecis Omega3 Wound®) applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze, second layer - absorbent gauze pads \& third layer - soft roll and compressive wrap (crepe bandage). For participants enrolled in the optional histopathological sub-study, a 2-mm punch biopsy will be obtained from the wound edge at baseline and on Day 5 under local anesthesia. Specimens will be fixed in 10% neutral buffered formalin, paraffin-embedded, and sectioned at 4 μm for histological and immunohistochemical analysis.

Sponsors & Collaborators

  • Mysore Medical College and Research Institute, Mysurur

    collaborator UNKNOWN

  • National Institute of Burn & Plastic Surgery, Dhaka

    collaborator UNKNOWN

  • EKAGRA Health, Dhaka

    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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-02-28
Completion
2027-03-31
FDA Device
Yes

Countries

  • Bangladesh
  • 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 NCT07781917 on ClinicalTrials.gov