Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:23 AM
Study NCT ID:
NCT07412561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D053546', 'term': 'Keratoderma, Palmoplantar, Epidermolytic'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D015776', 'term': 'Keratoderma, Palmoplantar, Diffuse'}, {'id': 'D007645', 'term': 'Keratoderma, Palmoplantar'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plantar Hyperkeratosis Surface Hardness (Shore A Scale)', 'timeFrame': 'Baseline (day 0, single study visit)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Tissue Stiffness (Elastography)', 'timeFrame': 'Baseline (day 0, single study visit)', 'description': 'Quantitative stiffness value obtained from ultrasound elastography within a standardized region of interest over the hyperkeratosis.'}, {'measure': 'Maximum and Mean Plantar Pressure at Hyperkeratosis Site', 'timeFrame': 'Baseline (day 0, single study visit)', 'description': 'Maximum and mean plantar pressure values (kPa) recorded using a calibrated pressure platform during static stance.'}, {'measure': 'Surface Temperature of Plantar Hyperkeratosis (Infrared Thermography)', 'timeFrame': 'Baseline (day 0, single study visit)', 'description': 'Mean and maximum surface temperature (°C) measured using standardized infrared thermography imaging.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Hyperkeratosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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 \\< 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'}, 'identificationModule': {'nctId': 'NCT07412561', 'briefTitle': 'Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Comparative Diagnostic Evaluation of Non-Invasive Instrumental Methods for Assessing Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes Mellitus Without Active Ulceration', 'orgStudyIdInfo': {'id': 'US-DIAG-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Subjects With Plantar Hyperkeratosis', 'description': '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.', 'interventionNames': ['Diagnostic Test: Instrumental Assessment of Plantar Hyperkeratosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetes Mellitus Without Active Foot Ulcer', 'description': '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.', 'interventionNames': ['Diagnostic Test: Instrumental Assessment of Plantar Hyperkeratosis']}], 'interventions': [{'name': 'Instrumental Assessment of Plantar Hyperkeratosis', 'type': 'DIAGNOSTIC_TEST', 'description': '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).', 'armGroupLabels': ['Diabetes Mellitus Without Active Foot Ulcer', 'Healthy Subjects With Plantar Hyperkeratosis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ángel Díaz del Río, MSc', 'role': 'CONTACT', 'email': 'angdiadel@alum.us.es', 'phone': '+34695985808'}, {'name': 'Ángel Díaz del Río, MSc', 'role': 'CONTACT', 'email': 'angeldiazdelrio23@gmail.com', 'phone': '+34695985808'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ángel Díaz del Río', 'investigatorAffiliation': 'University of Seville'}}}}