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HPTC Versus AFSM in Diabetic Foot Ulcers

Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara • ClinicalTrials.gov ID: NCT07781917

Registry updated: 2026-09-10

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Description

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.

Interventions

High Purity Type-I Collagen-Based Skin Substitute and SOC (Device)
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.
Acellular Intact Fish Skin Matrix and SOC (Device)
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.

Eligibility criteria

Inclusion Criteria: * Subjects must be at least 18 years of age or older. * Subjects must have a diagnosis of type 1 or 2 diabetes mellitus. * Diabetic foot ulcer located below the malleoli, Wagner Grade 1 or 2 (University of Texas Grade 1-2), without exposed bone. * Target ulcer present for a minimum of 4 weeks, with post-debridement area of approximately 5-20 cm². * Failure to achieve ≥30% ulcer-area reduction during the run-in period, or an equivalent documented waiver (Section 12.1). * Adequate circulation to the affected foot: ankle-brachial index (ABI) between 0.7 and 1.3 (or alternative vascular criteria per protocol). * Glycated haemoglobin (HbA1c) ≤ 12%. * The subject must consent to using the prescribed off-loading method for the duration of the study. * The subject must agree to attend the scheduled study visits required by the protocol. * The subject must be willing and able to participate in the informed consent process. * Patients must have read and signed the IEC-approved ICF before screening procedures are undertaken. Exclusion Criteria: * A subject known to have a life expectancy of less than 6 months. * If the target ulcer is infected or if there is cellulitis in the surrounding skin. * Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence; Wagner Grade ≥3. * A subject that has an infection in the target ulcer that requires systemic antibiotic therapy. * A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy. * Topical application of steroids to the ulcer surface within one month of initial screening. * A subject with a previous partial amputation on the affected foot, if the resulting deformity impedes proper offloading of the target ulcer. * A subject with glycated haemoglobin (HbA1c) greater than 12% at or within 3 months of the initial screening visit. * A subject with an acute Charcot foot, or an inactive Charcot foot that impedes proper offloading of the target ulcer. * Women who are pregnant or considering becoming pregnant within the next 6 months. * A subject with end-stage renal disease requiring dialysis; active malignancy. * A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days. * A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments. * A subject treated with hyperbaric oxygen therapy or a cellular and/or tissue product (CTP) in the 30 days prior to the initial screening visit. * Known hypersensitivity to HPTC or its components; known fish allergy/hypersensitivity for participants who would be allocated to AFSM.

Conditions

Diabetic Foot Ulcer (DFU)

Locations

National Institute of Burn & Plastic Surgery — Dhaka, Bangladesh
EKAGRA Health — Dhaka, Bangladesh
Adichunchanagiri Institute of Medical Sciences — Mandya, Karnataka, India
Mysore Medical College and Research Institute — Mysore, Karnataka, India

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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