[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626693":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":10,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":33,"eligibilityCriteria":34,"healthyVolunteers":29,"sex":35,"minAge":36,"maxAge":10,"enrollmentInfo":37,"targetDuration":10,"studyType":40,"phases":10,"briefSummary":41,"conditions":42,"keywords":44,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":10},{"fullName":5,"class":6},"ConvaTec Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox",null,[12],"Device: ConvaNiox",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","ConvaNiox","At each visit subjects will receive their Standard of Care (SoC) treatment for their DFU, but instead of their normal primary dressing they will receive an application of ConvaNiox (EDX110).",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Andrew Thomas","CONTACT","+44 (0) 7791904279","andrew.thomas@convatec.com",{"type":26,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100626693","a-study-on-the-efficacy-and-safety-of-a-nitric-oxide-generating-dressing-in-the-treatment-of-diabetes-related-foot-ulcers-100626693",false,"NCT07438951","A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.","A Prospective, Multi-Centre, Observational, Real World Evidence Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing (ConvaNiox™) in the Treatment of Diabetes Related Foot Ulcers (DFUs).","ONWARD","Inclusion Criteria:\n\nIC-1 - Subjects at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study\n\nIC-2 - The subject must have either type 1 or type 2 diabetes and a diabetes-related ulcer meeting all the following characteristics:\n\nIC-2a Classified as University of Texas (UT) Classification Grade 1 stages A-D IC-2b At or below the level of malleolus IC-2c Neuropathic or neuroischemic etiology confirmed through Electronic Medical Records (EMR) IC-2d Ulcer surface area between ≥1 and ≤25 cm² IC-2e For subjects who have more than one ulcer, the largest ulcer will be the study ulcer\n\nIC-3 Non-infected and infected ulcers are eligible for inclusion, with infection being classified using the International Working Group on the Diabetic Foot (IWGDF) Infection guidelines.\n\nOnly PEDIS 2 infections are permitted - Mild superficial skin and soft tissue infections with no systemic manifestations and involving:\n\n• Erythema extending ≥2 cm from the wound margin, and\u002For tissue deeper than skin and subcutaneous tissues (e.g., tendon, muscle, joint, and bone)\n\nIC-4 Adequate arterial supply in the lower extremity as defined by Wound, Ischemia, foot Infection (WIfI) Ischemia grade 0-1;\n\n1. Palpable foot pulse with biphasic or triphasic pedal Doppler waveforms, AND\n2. Ankle Brachial Index (ABI) \\>0.6 OR Toe Brachial Index (TBI) \\>0.5, OR\n3. Toe pressure \\>40mmHg\n\nExclusion Criteria:\n\nEC-1 Ulcers that are tunnelling or have cavities (\\>10mm in depth)\n\nEC-2 An ulcer that is actively bleeding. Subjects may be re-screened once active bleeding has stopped\n\nEC-3 Subjects taking any medication known to inhibit wound closure including chemotherapy and immunomodulatory biological agents. The use of systemic corticosteroids \\\u003C10mg\u002Fkg\u002Fday is permitted\n\nEC-4 Active Charcot foot","ALL","18 Years",{"count":38,"type":39},102,"ESTIMATED","OBSERVATIONAL","Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers",[43],"Diabetic Foot Ulcers (DFUs)",[45,46,47,48,49],"Diabetic foot ulcers","Nitric Oxide","Wound","dressing","Woundcare","NOT_YET_RECRUITING","2026-03-16",{"date":53,"type":54},"2026-03-18","ACTUAL",{"date":56,"type":39},"2026-07",{"date":58,"type":39},"2027-09",{"name":5,"class":6}]