[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624663":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":34,"studyPopulation":23,"armGroups":35,"interventions":46,"overallOfficials":23,"centralContacts":52,"locations":23,"responsibleParty":60,"collaborators":23,"id":64,"slug":23,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":23,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":23,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":23,"overallStatus":84,"whyStopped":23,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":23},{"fullName":5,"class":6},"University of Seville","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Plantar Hyperkeratosis Surface Hardness (Shore A Scale)","Mean superficial hardness value measured using a calibrated Shore A durometer applied perpendicularly over the plantar hyperkeratosis. The average of three consecutive measurements will be analyzed.","Baseline (day 0, single study visit)",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Tissue Stiffness (Elastography)","Quantitative stiffness value obtained from ultrasound elastography within a standardized region of interest over the hyperkeratosis.",{"measure":18,"description":19,"timeFrame":12},"Maximum and Mean Plantar Pressure at Hyperkeratosis Site","Maximum and mean plantar pressure values (kPa) recorded using a calibrated pressure platform during static stance.",{"measure":21,"description":22,"timeFrame":12},"Surface Temperature of Plantar Hyperkeratosis (Infrared Thermography)","Mean and maximum surface temperature (°C) measured using standardized infrared thermography imaging.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","Two parallel groups (healthy subjects and individuals with diabetes mellitus) undergoing a single-session, non-therapeutic instrumental assessment of plantar hyperkeratosis using pressure platform, durometer, elastography, and infrared thermography.","DIAGNOSTIC",{"masking":30,"maskingDescription":31,"whoMasked":32},"SINGLE","The statistical analyst assessing study outcomes will be blinded to participant group allocation. Due to the nature of the instrumental assessments, participant and investigator blinding was not feasible.",[33],"OUTCOMES_ASSESSOR","This is a randomized, controlled, cross-sectional clinical trial with two parallel groups: healthy subjects and patients with diabetes mellitus without active or recent plantar ulceration.\n\nAll participants present at least one clinically identifiable plantar hyperkeratosis. Each subject undergoes a standardized assessment in a single session using four non-invasive instrumental techniques: plantar pressure platform, durometer, ultrasound elastography, and infrared thermography.\n\nThe order of application of the instrumental methods is randomized. Primary outcomes include superficial hardness, tissue stiffness, plantar pressure distribution, and plantar surface temperature. Secondary outcomes include demographic, anthropometric, and clinical variables.\n\nThe study aims to compare inter-group differences, method agreement, reproducibility, and discriminative capacity of each instrumental technique.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"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.",[41],"Diagnostic Test: Instrumental Assessment of Plantar Hyperkeratosis",{"label":43,"type":38,"description":44,"interventionNames":45},"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.",[41],[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":23},"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).",[43,37],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":23,"email":57},"Ángel Díaz del Río, MSc","CONTACT","+34695985808","angdiadel@alum.us.es",{"name":54,"role":55,"phone":56,"phoneExt":23,"email":59},"angeldiazdelrio23@gmail.com",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Ángel Díaz del Río","Principal Investigator","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":75,"type":76},50,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82,83],"Diabetes Mellitus","Hyperkeratosis","NOT_YET_RECRUITING","2026-02-11",{"date":87,"type":88},"2026-02-17","ACTUAL",{"date":90,"type":76},"2026-02",{"date":92,"type":76},"2026-06",{"name":5,"class":6}]