[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497837":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":77,"collaborators":79,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":26,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":26,"enrollmentInfo":92,"targetDuration":26,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Community Pharmacology Services Ltd","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Device","EXPERIMENTAL","This Arm of the study will receive the study device. Although the Study Device is not experimental as it is already CE marked and being used for it's intended purpose.",[13],"Device: Wound Dressing",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR","This arm of the study will use the NHS' existing standard of care device as is normally used in podiatry clinics.",[19],"Device: NHS Standard Dressing",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Wound Dressing","RTD Wound Dressing that is being investigated",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"NHS Standard Dressing","This is the standard dressing used by NHS staff when currently dealing with a diabetic foot ulcer",[15],[32],{"name":33,"affiliation":34,"role":35},"Kaye McIntyre, MsC","NHS Lanarkshire","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Duncan Stang, MChS","CONTACT","07554333493","duncan.stang@lanarkshire.scot.nhs.uk",{"name":33,"role":39,"phone":43,"phoneExt":26,"email":44},"01236 748748","Kaye.McIntyre@lanarkshire.scot.nhs.uk",[46,63],{"facility":34,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Airdrie","North Lanarkshire","ML6 0JS","United Kingdom","UK",{"type":54,"coordinates":55},"Point",[56,57],-3.98025,55.86602,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":62,"phoneExt":26,"email":26},"Kaye McIntyre","01236 748 748",{"facility":64,"status":47,"city":65,"state":66,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"NHS Lothian","Livingston","West Lothian","EH54 6PP",{"type":54,"coordinates":69},[70,71],-3.52261,55.90288,{"lat":71,"lon":70},[74],{"name":75,"role":39,"phone":76,"phoneExt":26,"email":26},"Chris Jones","01506 523 000",{"type":78,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[80],{"name":81,"class":82},"Keneric Healthcare","UNKNOWN","100497837","diabetic-foot-ulcer-research-study-100497837",false,"NCT05762432","Diabetic Foot Ulcer Research Study","A Pilot Open Label Prospective, Randomised, Study to Evaluate the Safety and Efficacy of Keneric Healthcare RTD Wound Dressing in the Treatment of Diabetic Foot Ulcers Compared to Standard of Care","Inclusion Criteria:\n\n* Male or female, aged ≥18 years old with a diagnosis of type 1 or type 2 diabetes.\n* New presentation for treatment of a neuropathic, ischaemic or neuro- ischaemic non- infected DFU\n* Subjects must be able to follow verbal and written instructions in English\n* Subjects must have full mental capacity and able to give written informed consent to participation in the trial including medical photography for the purposes of the clinical trial or clinical care.\n* DFU is \\>10mm2 and \\\u003C100mm2\n\nExclusion Criteria:\n\n* Known allergy\u002Fhypersensitivity to any ingredient contained in the Keneric healthcare RTD Wound Dressing\n* Participants who will have problems following the protocol, including the offloading system, provided as standard of care, to wear on a daily basis\n* Suspected malignancy in the wound\n* Critical limb ischaemia\n* Pregnant or breastfeeding females\n* Women of childbearing potential and not using a medically accepted form of contraception when sexually active.","ALL","18 Years",{"count":93,"type":94},100,"ESTIMATED","INTERVENTIONAL",[97],"NA","The goal of this clinical trial is to compare safety and performance of the study device to the current typical NHS standards of care device. The main outcomes it aims to achieve are:\n\nComplete wound healing at 12 weeks (100% epithelialised)\n\n% Reduction in wound area at 12 weeks\n\nParticipants will attend their NHS podiatry clinic appointment as normal and will be assigned either the study device or the current typical NHS standard of care device. Researchers will compare the study device group to the standard group to assess the outcomes mentioned previously.",[100,101,102],"Diabetic Foot Ulcer","Diabetic Foot Ulcer Neuropathic","Diabetic Foot Ulcer Ischemic",[104,105,100],"Diabetes","Foot Ulcer","2026-01-23",{"date":108,"type":109},"2026-01-26","ACTUAL",{"date":111,"type":109},"2024-04-26",{"date":113,"type":94},"2027-01-01",{"name":5,"class":6},2]