RecruitingNot ApplicableNCT07781917

HPTC Versus AFSM in Diabetic Foot Ulcers

A Multicentric, Randomized, Controlled Clinical Trial Comparing High-Purity Type-I Collagen-Based Skin Substitute Versus Acellular Intact Fish Skin Matrix in the Treatment of Diabetic Foot Ulcers

Sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Enrollment

120 participants

Start Date

Aug 28, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer (DFU)

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Acellular Intact Fish Skin Matrix and SOC and a medical device called High Purity Type-I Collagen-Based Skin Substitute and SOC for people with diabetic foot ulcer (dfu). The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh 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 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.

DEVICEAcellular Intact Fish Skin Matrix and SOC

Arm B - The SOC in this study is wound care covering with Acellular Intact Fish Skin Matrix 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.