[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624663":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":33,"collaborators":24,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":24,"eligibilityCriteria":43,"healthyVolunteers":44,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":24,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":24,"overallStatus":58,"whyStopped":24,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":24},{"fullName":5,"class":6},"University of Seville","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Subjects With Plantar Hyperkeratosis","ACTIVE_COMPARATOR","Participants without diabetes mellitus presenting plantar hyperkeratosis who will undergo a single-session standardized instrumental assessment including pressure platform analysis, durometer measurement, elastography, and infrared thermography.",[13],"Diagnostic Test: Instrumental Assessment of Plantar Hyperkeratosis",{"label":15,"type":10,"description":16,"interventionNames":17},"Diabetes Mellitus Without Active Foot Ulcer","Participants diagnosed with diabetes mellitus (type 1 or type 2) without active foot ulcer, presenting plantar hyperkeratosis, who will undergo the same single-session standardized instrumental assessment including pressure platform analysis, durometer measurement, elastography, and infrared thermography.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Instrumental Assessment of Plantar Hyperkeratosis","Standardized, non-invasive diagnostic assessment of plantar hyperkeratosis performed in a single session, including plantar pressure analysis (pressure platform), superficial hardness measurement (durometer, Shore A scale), tissue stiffness evaluation (ultrasound elastography), and surface temperature analysis (infrared thermography).",[15,9],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Ángel Díaz del Río, MSc","CONTACT","+34695985808","angdiadel@alum.us.es",{"name":27,"role":28,"phone":29,"phoneExt":24,"email":32},"angeldiazdelrio23@gmail.com",{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Ángel Díaz del Río","Principal Investigator","100624663","instrumental-assessment-of-plantar-hyperkeratosis-in-healthy-subjects-and-patients-with-diabetes-100624663",false,"NCT07412561","Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes","Comparative Diagnostic Evaluation of Non-Invasive Instrumental Methods for Assessing Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes Mellitus Without Active Ulceration","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presence of at least one clinically identifiable plantar hyperkeratosis\n* Intact skin without ulceration\n* Ability to maintain standing position for at least 30 seconds\n* Signed informed consent\n\nAdditional Inclusion Criteria for Diabetes Mellitus Group:\n\n* Medical diagnosis of type 1 or type 2 diabetes mellitus\n* No active foot ulcer\n* No history of foot ulcer within the previous 12 months\n\nExclusion Criteria:\n\n* Active plantar ulcer, pre-ulcerative lesion, or recent ulcer scar\n* Severe peripheral neuropathy (absence of protective sensation with 10 g monofilament)\n* Severe peripheral arterial disease (Ankle-Brachial Index \\\u003C 0.8)\n* Foot surgery within the previous 6 months\n* Active inflammatory, infectious, or dermatological condition at measurement site\n* Use of keratolytic treatments or debridement within the previous 15 days\n* Inability to complete the full assessment protocol",true,"ALL","18 Years","90 Years",{"count":49,"type":50},50,"ESTIMATED","INTERVENTIONAL",[53],"NA","This randomized clinical trial aims to compare the diagnostic performance, reproducibility, and agreement of several non-invasive instrumental methods for assessing plantar hyperkeratosis hardness in healthy subjects and patients with diabetes mellitus without active foot ulceration.\n\nParticipants will be evaluated in a single study session using plantar pressure platform analysis, durometer measurements, ultrasound elastography, and infrared thermography. The study seeks to identify the most reliable and discriminative methods for clinical and preventive assessment of plantar hyperkeratosis, particularly in populations at risk for diabetic foot complications.",[56,57],"Diabetes Mellitus","Hyperkeratosis","NOT_YET_RECRUITING","2026-02-11",{"date":61,"type":62},"2026-02-17","ACTUAL",{"date":64,"type":50},"2026-02",{"date":66,"type":50},"2026-06",{"name":5,"class":6}]