[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medical Intelligence Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"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":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100593977","study-to-assess-remote-imaging-system-to-monitor-diabetic-foot-ulcers-100593977",false,"NCT07013448","Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers","Pilot Study of a Novel Non-invasive Multimodal Imaging System in the Monitoring of Diabetic Foot Ulcer Progression","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosed with a diabetic foot ulcer at the time of recruitment\n* Receiving routine care at the participating NHS clinic\n* Able to provide informed consent\n* Able to sit and engage with the TASHA scanning device\n* Willing to attempt a supervised self-scan of the affected foot\n\nExclusion Criteria:\n\n* Presence of non-diabetic foot ulcers\n* Severe cognitive or physical impairments that prevent scanning or understanding instructions\n* Active infection or medical instability requiring urgent intervention\n* Participation in another interventional study that may interfere with this assessment\n* Inability to communicate in English (unless appropriate translation or support is available)","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","OBSERVATIONAL","The goal of this observational pilot study is to evaluate whether a new remote monitoring platform (TASHA) can support accurate and reliable assessment of diabetic foot ulcers in adult patients receiving care in a UK NHS clinic. The main questions it aims to answer are:\n\nCan the TASHA platform provide ulcer assessment data (e.g., size, depth, visible infection) that aligns with in-clinic evaluations by healthcare professionals? Can patients accurately perform self-scanning of their ulcers using the platform under clinical supervision? What is the variation (inc. root mean square error) between clinician-led and patient-led scans?\n\nParticipants will:\n\n* Attend a standard in-clinic ulcer assessment as part of their usual care Undergo an additional 3D foot scan using the TASHA platform during their clinic visit.\n* Be guided to perform a self-scan using the same platform, with clinical staff present.\n* Have their scan data reviewed remotely by a clinician to compare with in-clinic assessments.\n* This feasibility study will inform the design of future larger-scale trials and contribute to regulatory development of the TASHA platform as a digital medical device.",[24,25],"Diabetic Foot Ulcer","Diabetic Foot Ulcer (DFU)",[27,28],"DFU","Monitoring","NOT_YET_RECRUITING","2025-06-02",{"date":32,"type":33},"2025-06-10","ACTUAL",{"date":35,"type":20},"2025-09",{"date":37,"type":20},"2026-06",{"name":39,"class":40},"Medical Intelligence Group","INDUSTRY",""]