HPTC Versus AFSM in Diabetic Foot Ulcers

Prior treatment

• A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy.
• A subject with a previous partial amputation on the affected foot, if the resulting deformity impedes proper offloading of the target ulcer.
• A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
• 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.

Other illness

• If the target ulcer is infected or if there is cellulitis in the surrounding skin.
• A subject that has an infection in the target ulcer that requires systemic antibiotic therapy.
• Topical application of steroids to the ulcer surface within one month of initial screening.
• A subject with an acute Charcot foot, or an inactive Charcot foot that impedes proper offloading of the target ulcer.
• A subject with end-stage renal disease requiring dialysis; active malignancy.
• A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
• Known hypersensitivity to HPTC or its components; known fish allergy/hypersensitivity for participants who would be allocated to AFSM.

Lab values

• A subject with glycated haemoglobin (HbA1c) greater than 12% at or within 3 months of the initial screening visit.

Other

• A subject known to have a life expectancy of less than 6 months.
• Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence; Wagner Grade ≥3.
• Women who are pregnant or considering becoming pregnant within the next 6 months.

• 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.