[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653167":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":67,"studyPopulation":61,"armGroups":68,"interventions":80,"overallOfficials":94,"centralContacts":99,"locations":109,"responsibleParty":172,"collaborators":174,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":61,"eligibilityCriteria":188,"healthyVolunteers":184,"sex":189,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":61,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":207,"whyStopped":61,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"Adichunchanagiri Institute of Medical Sciences, B G Nagara","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Participants Achieving Confirmed Complete Wound Closure","Complete wound closure is defined as 100% epithelialization of the target ulcer with no drainage and no clinically evident open area requiring dressing, confirmed by a blinded central adjudicator at a follow-up visit approximately 7 days after initial clinical closure is observed.","Up to Week 13 (initial closure assessed through Week 12; confirmation visit approximately 7 days later)",[14,18,22,26,30,33,37,41],{"measure":15,"description":16,"timeFrame":17},"Percentage Wound Area Reduction Over Time","Percentage reduction in wound area from baseline, measured by standardized digital photography and central digital planimetry.","Weeks 2, 4, 6, 8, and 12",{"measure":19,"description":20,"timeFrame":21},"Proportion Achieving ≥50%, ≥75%, and ≥90% Wound-Area Reduction","Proportion of participants achieving each threshold of wound-area reduction relative to baseline.","Week 12",{"measure":23,"description":24,"timeFrame":25},"Time to Confirmed Complete Wound Closure","Time from randomization to confirmed complete closure of the target ulcer, analyzed by Kaplan-Meier methods.","Up to Week 13",{"measure":27,"description":28,"timeFrame":29},"Mean Number of Study-Product Applications","Average number of applications of HPTC or AFSM required to achieve wound closure or study completion.","Up to Week 6",{"measure":31,"description":32,"timeFrame":25},"Number of Participants with Adverse Events","Number of participants experiencing adverse events related to the intervention (e.g., infection, allergic reaction, local irritation).",{"measure":34,"description":35,"timeFrame":36},"Patient-Reported Quality of Life (DFS-SF)","Diabetic Foot Ulcer Scale-Short Form, four subscales (physical functioning, daily activities, emotions, social functioning), 0-100 per subscale, higher = better.","Baseline and Week 12",{"measure":38,"description":39,"timeFrame":40},"Scar Quality (Vancouver Scar Scale)","Vancouver Scar Scale assessing pigmentation, pliability, height, and vascularity; total score 0-13, lower = better.","Week 12 or at confirmed closure",{"measure":42,"description":43,"timeFrame":25},"Ulcer Recurrence","Recurrence of the index ulcer after confirmed closure, monitored through study completion.",[45,49,52,55],{"measure":46,"description":47,"timeFrame":48},"Tissue Advanced Glycation End-Product Accumulation (CML)","Quantification of Nε-(carboxymethyl)lysine (CML), a marker of tissue advanced glycation end-product accumulation relevant to impaired diabetic wound healing, in wound-edge biopsy specimens by ELISA (preferred) or immunohistochemistry with anti-CML antibody.\n\nAnalysis Population Description: Histopathological sub-study subset only (approximately 30-40 participants, balanced between arms, at selected centres) - not assessed in the full 120-participant population.","Baseline (Day 0) and Day 5",{"measure":50,"description":51,"timeFrame":48},"Quantitative Collagen Organization and Maturation","Collagen density, fibre alignment, fibre orientation, and degree of organization in wound-edge biopsy specimens, assessed by Masson's Trichrome or Picrosirius Red staining with polarized light microscopy and quantified using digital image analysis software (ImageJ or QuPath).\n\nAnalysis Population Description: Histopathological sub-study subset only.",{"measure":53,"description":54,"timeFrame":48},"Microvessel Density and Vascular Maturation","Angiogenesis assessed by CD31 immunohistochemistry (endothelial cell count, microvessel density expressed as vessels per high-power field, and CD31-positive area percentage), and vascular maturation assessed by α-smooth muscle actin (α-SMA) immunohistochemistry (mature\u002Fstabilized vessel count and activated myofibroblast density).\n\nAnalysis Population Description: Histopathological sub-study subset only.",{"measure":56,"description":57,"timeFrame":48},"General Histopathological Wound Response (H&E)","Hematoxylin and eosin-stained wound-edge biopsy specimens assessed for inflammatory cell infiltrate, necrosis, epithelial migration, granulation tissue formation, and overall tissue architecture.\n\nAnalysis Population Description: Histopathological sub-study subset only.",{"allocation":59,"interventionModel":60,"interventionModelDescription":61,"primaryPurpose":62,"observationalModel":61,"timePerspective":61,"maskingInfo":63},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":64,"maskingDescription":61,"whoMasked":65},"SINGLE",[66],"OUTCOMES_ASSESSOR","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.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"High Purity Type-I Collagen-Based Skin Substitute and SOC","ACTIVE_COMPARATOR","The SOC in this study is wound care covering with High Purity Type-I Collagen-Based Skin Substitute (Helicoll®) applied weekly or as needed, followed by a padded 3-layer dressing (non-adherent porous paraffin gauze; absorbent gauze pads; soft roll and compressive crepe bandage).",[74],"Device: High Purity Type-I Collagen-Based Skin Substitute and SOC",{"label":76,"type":71,"description":77,"interventionNames":78},"Acellular Intact Fish Skin Matrix and SOC","The SOC in this study is wound care covering with Acellular Intact Fish Skin Matrix (Kerecis Omega3 Wound®) applied weekly or as needed, followed by the same padded 3-layer dressing described above.",[79],"Device: Acellular Intact Fish Skin Matrix and SOC",[81,88],{"type":82,"name":70,"description":83,"armGroupLabels":84,"otherNames":85},"DEVICE","Arm A - The SOC in this study is wound care covering with High Purity Type-I Collagen-Based Skin Substitute (Helicoll®) 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).\n\nFor 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.",[70],[86,87],"Helicoll","HPTC",{"type":82,"name":76,"description":89,"armGroupLabels":90,"otherNames":91},"Arm B - The SOC in this study is wound care covering with Acellular Intact Fish Skin Matrix (Kerecis Omega3 Wound®) 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).\n\nFor 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.",[76],[92,93],"AFSM","Intact Fish Skin Graft",[95],{"name":96,"affiliation":97,"role":98},"Prema Dhanraj, MS, MCh","Rajarajeshwari Medical College and Hospital","STUDY_CHAIR",[100,105],{"name":101,"role":102,"phone":103,"phoneExt":61,"email":104},"Naveen Narayan","CONTACT","9980023372","naveennumerouno@gmail.com",{"name":106,"role":102,"phone":107,"phoneExt":61,"email":108},"Chethan Shivannaiah","8277520509","drrschethan@gmail.com",[110,125,134,157],{"facility":111,"status":61,"city":112,"state":61,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"National Institute of Burn & Plastic Surgery","Dhaka","1000","Bangladesh","BD",{"type":117,"coordinates":118},"Point",[119,120],90.40744,23.7104,{"lat":120,"lon":119},[123],{"name":124,"role":102,"phone":61,"phoneExt":61,"email":61},"Shawon B Rahman, MBBS, MS",{"facility":126,"status":61,"city":112,"state":61,"zip":127,"country":114,"countryCode":115,"cosmosGeoPoint":128,"geoPoint":130,"contacts":131},"EKAGRA Health","1209",{"type":117,"coordinates":129},[119,120],{"lat":120,"lon":119},[132],{"name":133,"role":102,"phone":61,"phoneExt":61,"email":61},"Rashedul M Rashedul, MBBS, FACS",{"facility":135,"status":61,"city":136,"state":137,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Adichunchanagiri Institute of Medical Sciences","Mandya","Karnataka","571448","India","IN",{"type":117,"coordinates":142},[143,144],76.89746,12.5223,{"lat":144,"lon":143},[147,149,153,155],{"name":148,"role":102,"phone":103,"phoneExt":61,"email":104},"Naveen Narayan, MS, MCh",{"name":150,"role":102,"phone":61,"phoneExt":151,"email":152},"Chethan Shivannaiah, DNB","Narayan","drschethan@gmail.com",{"name":148,"role":154,"phone":61,"phoneExt":61,"email":61},"PRINCIPAL_INVESTIGATOR",{"name":150,"role":156,"phone":61,"phoneExt":61,"email":61},"SUB_INVESTIGATOR",{"facility":158,"status":61,"city":159,"state":137,"zip":160,"country":139,"countryCode":140,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Mysore Medical College and Research Institute","Mysore","570001",{"type":117,"coordinates":162},[163,164],76.63925,12.29791,{"lat":164,"lon":163},[167,171],{"name":168,"role":102,"phone":169,"phoneExt":61,"email":170},"Vijay Kumar, MS, MCh","9141716348","naveen_uno1@yahoo.co.in",{"name":168,"role":154,"phone":61,"phoneExt":61,"email":61},{"type":173,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR",[175,178,180],{"name":176,"class":177},"Mysore Medical College and Research Institute, Mysurur","UNKNOWN",{"name":179,"class":177},"National Institute of Burn & Plastic Surgery, Dhaka",{"name":181,"class":177},"EKAGRA Health, Dhaka","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":193,"type":194},120,"ESTIMATED","INTERVENTIONAL",[197],"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.",[200],"Diabetic Foot Ulcer (DFU)",[202,203,204,205,206],"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":210,"type":211},"2026-08-24","ACTUAL",{"date":213,"type":194},"2026-08",{"date":215,"type":194},"2027-03",{"name":5,"class":6},4]