[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644163":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":53,"collaborators":10,"id":55,"slug":10,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":71,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Diabetis JSC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Type 1 or Type 2 diabetes, recruited from outpatient clinics",null,"Approximately 20 adults (≥18 years) with Type 1 or Type 2 diabetes, recruited from outpatient clinics at UT Health San Antonio",[13],"Device: Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device",": after initial training, participants set up and use the Feetsee foot-monitoring system in their own homes, following the US IFU and in-app instructions. Data will be collected via paper\u002Felectronic CRFs, patient questionnaires, and Feetsee device\u002Fapp usage logs (exported to REDCap and secure sponsor databases).",[9],[21],{"name":22,"affiliation":23,"role":24},"Lawrence A. Lavery, MD","The University of Texas Health Science Center at San Antonio","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Helena Grinberg, PhD","CONTACT","+31615636666","lenagrin@gmail.com",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":10},"Rytis Zajančkauskas, MD","rytis@diabetis.lt",[35],{"facility":36,"status":10,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"UT Health San Antonio","San Antonio","Texas","78229","United States",{"type":42,"coordinates":43},"Point",[44,45],-98.49363,29.42412,{"lat":45,"lon":44},[48,52],{"name":49,"role":28,"phone":50,"phoneExt":10,"email":51},"Nick Lucio","210-567-5142","luciond@uthscsa.edu",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100644163",false,"NCT07666087","Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes","Inclusion Criteria:\n\n* Males and females aged 18 years or older\n* Clinical diagnosis of Type 1 or Type 2 diabetes\n* At least one palpable foot pulse per feet\n* Possess basic ability to use a smartphone or tablet\n* Have no prior experience with the Feetsee™ system\n* Be willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Active foot ulceration at enrollment\n* Active Charcot neuro-osteoarthropathy\n* Severe vascular disease (complete absence of foot pulses)\n* Amputation of more than three toes\n* Active malignancy or immunosuppressive condition\n* Cognitive or physical impairments preventing proper device usage\n* Concurrent participation in another investigational study with contraindicated procedures","ALL","18 Years",{"count":63,"type":64},20,"ESTIMATED","OBSERVATIONAL","Single-center, prospective, minimal-risk, non-experimental usability study assessing the setup and use of the FDA-registered (Class I medical device; 510(k)-exempt) Feetsee™ home foot-monitoring system by adults with diabetes in their home environment over 8 weeks.\n\nThis study in non clinical, observational pilot usability study conducted under FDA Human Factors and Usability Engineering guidance (2016).",[68],"Diabetes",[70],"Foot monitoring","NOT_YET_RECRUITING","2026-06-18",{"date":74,"type":75},"2026-06-24","ACTUAL",{"date":77,"type":64},"2026-07-10",{"date":79,"type":64},"2027-07-10",{"name":5,"class":6},1]