[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Adichunchanagiri Institute of Medical Sciences, B G Nagara\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100653167","hptc-versus-afsm-in-diabetic-foot-ulcers-100653167",false,"NCT07781917","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","Inclusion Criteria:\n\n* Subjects must be at least 18 years of age or older.\n* Subjects must have a diagnosis of type 1 or 2 diabetes mellitus.\n* Diabetic foot ulcer located below the malleoli, Wagner Grade 1 or 2 (University of Texas Grade 1-2), without exposed bone.\n* Target ulcer present for a minimum of 4 weeks, with post-debridement area of approximately 5-20 cm².\n* Failure to achieve ≥30% ulcer-area reduction during the run-in period, or an equivalent documented waiver (Section 12.1).\n* Adequate circulation to the affected foot: ankle-brachial index (ABI) between 0.7 and 1.3 (or alternative vascular criteria per protocol).\n* Glycated haemoglobin (HbA1c) ≤ 12%.\n* The subject must consent to using the prescribed off-loading method for the duration of the study.\n* The subject must agree to attend the scheduled study visits required by the protocol.\n* The subject must be willing and able to participate in the informed consent process.\n* Patients must have read and signed the IEC-approved ICF before screening procedures are undertaken.\n\nExclusion Criteria:\n\n* A subject known to have a life expectancy of less than 6 months.\n* If the target ulcer is infected or if there is cellulitis in the surrounding skin.\n* Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence; Wagner Grade ≥3.\n* A subject that has an infection in the target ulcer that requires systemic antibiotic therapy.\n* A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy.\n* Topical application of steroids to the ulcer surface within one month of initial screening.\n* A subject with a previous partial amputation on the affected foot, if the resulting deformity impedes proper offloading of the target ulcer.\n* A subject with glycated haemoglobin (HbA1c) greater than 12% at or within 3 months of the initial screening visit.\n* A subject with an acute Charcot foot, or an inactive Charcot foot that impedes proper offloading of the target ulcer.\n* Women who are pregnant or considering becoming pregnant within the next 6 months.\n* A subject with end-stage renal disease requiring dialysis; active malignancy.\n* A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* A subject treated with hyperbaric oxygen therapy or a cellular and\u002For tissue product (CTP) in the 30 days prior to the initial screening visit.\n* Known hypersensitivity to HPTC or its components; known fish allergy\u002Fhypersensitivity for participants who would be allocated to AFSM.","ALL","18 Years","75 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27],"Diabetic Foot Ulcer (DFU)",[29,30,31,32,33],"Diabetic Foot Ulcer;","High Purity Type-I Collagen-Based Skin Substitute;","Acellular Intact Fish Skin Matrix;","Randomized Controlled Clinical Trial;","Multicentric Study;","NOT_YET_RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-24","ACTUAL",{"date":40,"type":21},"2026-08",{"date":42,"type":21},"2027-03",{"name":44,"class":45},"Adichunchanagiri Institute of Medical Sciences, B G Nagara","OTHER",4,""]