[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644163":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":58,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"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,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"UT Health San Antonio","San Antonio","Texas","78229","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-98.49363,29.42412,{"lat":46,"lon":45},[49,53],{"name":50,"role":28,"phone":51,"phoneExt":10,"email":52},"Nick Lucio","210-567-5142","luciond@uthscsa.edu",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100644163","pilot-usability-study-to-set-up-and-use-the-feetsee-foot-monitoring-device-in-adults-with-diabetes-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":65,"type":66},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).",[70],"Diabetes",[72],"Foot monitoring","NOT_YET_RECRUITING","2026-06-18",{"date":76,"type":77},"2026-06-24","ACTUAL",{"date":79,"type":66},"2026-07-10",{"date":81,"type":66},"2027-07-10",{"name":5,"class":6},1]