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

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.

The purpose of this study is to compare the safety and efficacy of a high-purity type-I collagen-based skin substitute (HPTC) versus an acellular intact fish-skin matrix (AFSM) in the treatment of diabetic foot ulcers (DFUs), each combined with standardized background wound care. Eligible participants with a Wagner Grade 1-2 target ulcer will be randomized 1:1, stratified by centre and baseline ulcer-size stratum, to receive HPTC or AFSM. The primary outcome is the proportion of participants achieving confirmed complete closure of the target ulcer by Week 12. Outcome assessment (digital planimetry and closure adjudication) is performed by assessors blinded to treatment allocation.

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.