High-Purity Collagen Skin Substitute vs Fish Skin Matrix for Diabetic Foot Ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, multicenter comparison of two skin substitutes used with standard wound care to treat Wagner 1-2 diabetic foot ulcers in adults. Participants are assigned to receive either the high-purity type-I collagen-based skin substitute (HPTC) or an acellular intact fish skin matrix (AFSM), with treatment allocation stratified by center and initial ulcer size. The primary endpoint is the proportion of participants with complete ulcer closure by 12 weeks, assessed by digital planimetry with assessors blinded to treatment. Secondary considerations include safety and ulcer-area changes over time. Eligible centers are in India and Bangladesh, reflecting a real-world, diverse patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Naveen Narayan
• Email: naveennumerouno@gmail.com
• Phone: 9980023372

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.