[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-foot-wounds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-foot-wounds":29},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100608846","chemfoot-debrichem-in-chronic-diabetic-foot-wounds-100608846",false,"NCT07206862","CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds","Clinical Evaluation of the Addition of DEBRICHEM® to the Routine Management of Chronic Diabetic Foot Wounds: an Open-label Randomized Controlled Trial (CHEMfoot Study)","CHEMfoot","Inclusion Criteria:\n\n* Adults ≥18 years.\n* Diabetic foot ulcer (toe, dorsal, plantar, or lateral foot) persisting ≥4 weeks without improvement.\n* Requires debridement.\n* Wound size 0.5-10 cm².\n* Texas classification 0-IIC (controlled neuro-ischemic ulcers, localized infection only).\n* HbA1c ≤10% in last 3 months. Peripheral arterial disease controlled, no critical limb ischemia (toe pressure \\>50 mmHg OR ankle pressure \\>70 mmHg OR TcPO2 \\>30 mmHg).\n\nExclusion Criteria:\n\n* Allergy to DEBRICHEM® components.\n* Active malignancy, osteomyelitis, fasciitis, exposed cartilage.\n* Revascularization \\\u003C4 weeks prior.\n* Systemic infection.\n* Pregnant or breastfeeding women.\n* Vulnerable populations under legal protection.\n* Participation in another clinical trial.","ALL","18 Years",{"count":20,"type":21},242,"ESTIMATED","INTERVENTIONAL",[24],"NA","This multicenter, randomized controlled trial will evaluate the effectiveness and safety of DEBRICHEM®, a topical desiccant gel, when added to standard care for chronic diabetic foot wounds. Chronic diabetic foot ulcers affect up to 25% of people with diabetes and are associated with high risks of infection, hospitalization, amputation, and mortality. Biofilm formation plays a key role in wound chronicity and delayed healing. DEBRICHEM® is designed to chemically debride wounds by removing biofilm in a single topical application, potentially accelerating the healing process.\n\nA total of 242 adult patients with chronic diabetic foot ulcers (≥4 weeks, 0.5-10 cm²) will be randomized to receive either conventional wound care plus a single application of DEBRICHEM® or conventional wound care alone. The primary endpoint is the proportion of patients achieving complete wound healing at 20 weeks. Secondary outcomes include wound size reduction, infection rates, pain, quality of life, sleep, healthcare resource use, and safety.",[27,28,29],"Diabetic Foot Ulcer (DFU)","Diabetic Foot Ulcer Treatment","Diabetic Foot Wounds",[31,32,33,34,35,36],"chemical debridement","DEBRICHEM","topical desiccating agent","TDA","DFU","diabetic foot ulcer","NOT_YET_RECRUITING","2025-10-01",{"date":40,"type":41},"2025-10-03","ACTUAL",{"date":43,"type":21},"2025-10",{"date":45,"type":21},"2027-02",{"name":47,"class":48},"DEBx Medical B.V.","INDUSTRY"]