[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593977":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":79,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Medical Intelligence Group","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with DFU",null,"Only one group used as all participants will receive the standard care as well as have a foot scan take with a non-invasive and non-ionising scanner",[13],"Other: Foot scan",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"OTHER","Foot scan","This does not constitute a intervention but all participants will undergo image scans of their ulcer",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Sagar Jadeja, BDS, PhD, MFDS, AKC","CONTACT","+447923387582","sagar@mig-health.com",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Divia Bhatnagar, BSc, MEng","+44 7725 91685","divia@mig-health.com",[31],{"facility":32,"status":10,"city":33,"state":34,"zip":35,"country":36,"countryCode":34,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Tameside General Hospital","Ashton-under-Lyne","UK","OL6 9RW","United Kingdom",{"type":38,"coordinates":39},"Point",[40,41],-2.0989,53.48876,{"lat":41,"lon":40},[44,48,51],{"name":45,"role":23,"phone":46,"phoneExt":10,"email":47},"Margaret Cooper","+440161 922 4011","Margaret.Cooper@tgh.nhs.uk",{"name":49,"role":23,"phone":10,"phoneExt":10,"email":50},"Rebecca Roberts","Rebecca.Roberts@tgh.nhs.uk",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Edward Jude, MBBS, MD, FRCP","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57],{"name":58,"class":16},"Tameside Hospital NHS Foundation Trust","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":69,"type":70},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.",[74,75],"Diabetic Foot Ulcer","Diabetic Foot Ulcer (DFU)",[77,78],"DFU","Monitoring","NOT_YET_RECRUITING","2025-06-02",{"date":82,"type":83},"2025-06-10","ACTUAL",{"date":85,"type":70},"2025-09",{"date":87,"type":70},"2026-06",{"name":5,"class":6},1]