Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:48 AM
Study NCT ID:
NCT07463456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermographic Camera Validation for Diabetic Foot Assessment (HIK-DM-2026)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraclass Correlation Coefficient (ICC) of absolute agreement for maximum contralateral thermal asymmetry (Delta T_max) between HIKMICRO Mini2 V2 and M60', 'timeFrame': 'Single measurement session (Day 1)', 'description': 'ICC calculated using a two-way mixed-effects model. ICC \\> 0.90 defined as excellent agreement. Delta T\\_max is the highest contralateral thermal asymmetry value among 6 plantar regions of interest per participant.'}, {'measure': 'Bland-Altman limits of agreement for Delta T_max', 'timeFrame': 'Single measurement session (Day 1)'}], 'secondaryOutcomes': [{'measure': "Cohen's Kappa for binary classification of clinical risk hot spot (Delta T_max > 2.2 deg C)", 'timeFrame': 'Single measurement session (Day 1)'}, {'measure': 'Sensitivity and Specificity of HIKMICRO Mini2 V2 for hot spot detection using M60 as reference standard', 'timeFrame': 'Single measurement session (Day 1)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thermography', 'infrared', 'concordance', 'ICC', 'low-cost', 'HIKMICRO', 'plantar temperature', 'diabetic foot screening'], 'conditions': ['Diabetic Foot', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 1 or type 2 diabetes mellitus attending the outpatient clinic for diabetic foot screening and assessment.', 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT07463456', 'briefTitle': 'Thermographic Camera Validation for Diabetic Foot Assessment (HIK-DM-2026)', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Canarias'}, 'officialTitle': 'Thermographic Camera Validation for Diabetic Foot Assessment', 'orgStudyIdInfo': {'id': 'HIK-DM-2026-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes patients', 'description': 'Adults with diagnosed type 1 or type 2 diabetes mellitus, without active foot ulcers', 'interventionNames': ['Device: HIKMICRO® Mini2 V2', 'Device: HIKMICRO® M60']}], 'interventions': [{'name': 'HIKMICRO® Mini2 V2', 'type': 'DEVICE', 'description': 'Low-cost infrared thermographic camera (256x192 px, NETD \\<40mK, cost \\~200€)', 'armGroupLabels': ['Diabetes patients']}, {'name': 'HIKMICRO® M60', 'type': 'DEVICE', 'description': 'Professional infrared thermographic camera used as clinical reference standard', 'armGroupLabels': ['Diabetes patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38300', 'city': 'La Orotava', 'state': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Universidad Europea de Canarias', 'geoPoint': {'lat': 28.39076, 'lon': -16.52309}}], 'centralContacts': [{'name': 'Eduardo Luis Martín Javier', 'role': 'CONTACT', 'email': 'eduardoluis.martin@universidadeuropea.es', 'phone': '+34 922 09 70 91'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Canarias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Podiatrist, PhD Candidate', 'investigatorFullName': 'Eduardo Luis Martín Javier', 'investigatorAffiliation': 'Universidad Europea de Canarias'}}}}