[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628578":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":25,"locations":31,"responsibleParty":44,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":10,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":10,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Universidad Europea de Canarias","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Diabetes patients",null,"Adults with diagnosed type 1 or type 2 diabetes mellitus, without active foot ulcers",[13,14],"Device: HIKMICRO® Mini2 V2","Device: HIKMICRO® M60",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DEVICE","HIKMICRO® Mini2 V2","Low-cost infrared thermographic camera (256x192 px, NETD \\\u003C40mK, cost \\~200€)",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"HIKMICRO® M60","Professional infrared thermographic camera used as clinical reference standard",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Eduardo Luis Martín Javier","CONTACT","+34 922 09 70 91","eduardoluis.martin@universidadeuropea.es",[32],{"facility":5,"status":10,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":10},"La Orotava","Santa Cruz de Tenerife","38300","Spain","ES",{"type":39,"coordinates":40},"Point",[41,42],-16.52309,28.39076,{"lat":42,"lon":41},{"type":45,"investigatorFullName":27,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Podiatrist, PhD Candidate","100628578","thermographic-camera-validation-for-diabetic-foot-assessment-hik-dm-2026-100628578",false,"NCT07463456","Thermographic Camera Validation for Diabetic Foot Assessment (HIK-DM-2026)","Thermographic Camera Validation for Diabetic Foot Assessment","Inclusion Criteria:\n\n* Age 18 years and older.\n* Diagnosed with Type 1 or Type 2 Diabetes Mellitus.\n* Ability to understand and sign the informed consent.\n\nExclusion Criteria:\n\n* Active foot ulcers.\n* Recent surgery on the lower limbs.\n* Cognitive impairment that prevents following the study protocol.","ALL","18 Years",{"count":57,"type":58},130,"ESTIMATED","OBSERVATIONAL","This cross-sectional observational study validates the concordance of a low-cost thermographic camera (HIKMICRO Mini2 V2, \\~200 Euro) against a professional clinical standard (HIKMICRO M60) for diabetic foot assessment. Both cameras simultaneously capture plantar thermographic images from 130 participants with diabetes mellitus. Maximum contralateral thermal asymmetry (Delta T\\_max) across 6 plantar regions of interest (ROIs) is the primary endpoint, analyzed by intraclass correlation coefficient (ICC) and Bland-Altman method.",[62,63],"Diabetic Foot","Diabetes Mellitus",[65,66,67,68,69,70,71,72],"thermography","infrared","concordance","ICC","low-cost","HIKMICRO","plantar temperature","diabetic foot screening","NOT_YET_RECRUITING","2026-03-10",{"date":76,"type":77},"2026-03-13","ACTUAL",{"date":79,"type":58},"2026-04",{"date":81,"type":58},"2026-12",{"name":5,"class":6},1]