Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-01 @ 9:48 AM
Study NCT ID:
NCT06515769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Thermography for the Prevention and Diagnosis of Rheumatic Foot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NORMAL PARAMETERS IN THERMOGRAPHY IN PATIENS WITH HEALTHY FOOT', 'timeFrame': 'One measurement will be taken at the start of the study and another measurement the following 6 month.', 'description': 'Normal parameters of the healthy foot in thermography'}], 'secondaryOutcomes': [{'measure': 'NORMAL PARAMETERS IN TERMOGRAPHY IN PATIENS WITH RHEUMATIC FOOT', 'timeFrame': 'One measurement will be taken at the start of the study and another measurement the following 6 month', 'description': 'Normal parameters in thermography in patients with rheumatic foot'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatic foot', 'Rheumatoid Arthritis', 'Rheumatic diseases', 'Thermoghrapy'], 'conditions': ['Rheumatoid Arthritis', 'Rheumatoid Arthritis RA', 'Rheumatic Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to establish normal thermographic parameters in patients with rheumatoid arthritis, in order to prevent and diagnose rheumatic foot using thermography. The main question to be answered is: What are the normal thermographic parameters in rheumatic foot?\n\nIf there is a comparison group: the researchers will compare the thermography of the foot in healthy subjects and in subjects with rheumatoid arthritis to see if there are any alterations in the thermographic image.\n\nPatients who wish to participate in the study will undergo a thermographic study of the foot, which does not entail any risk to their health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Selected patients will be healthy subjects and subjects with more than 5 years of rheumatoid arthritis who wish to voluntarily participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with rheumatoid arthritis of more than 5 years\\' duration\n* Healthy patients without diagnosed systemic disease\n* Patients between 40 and 80 years of age\n\nExclusion Criteria:\n\n* Patients who are pregnant or may become pregnant\n* Patients with degenerative diseases or significant cognitive impairment\n* Patients with rheumatic diseases without a diagnosis of rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT06515769', 'acronym': 'TG-AR', 'briefTitle': 'Use of Thermography for the Prevention and Diagnosis of Rheumatic Foot', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Use of Thermography for the Prevention and Diagnosis of Rheumatic Foot', 'orgStudyIdInfo': {'id': 'TERMOGRAPHYAR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group: healthy subjects', 'description': 'Subjects without rheumatoid arthritis or symptoms compatible with this disease', 'interventionNames': ['Diagnostic Test: TERMOGRAPHY']}, {'label': 'Case group: subjects with rheumatoid arthritis', 'description': 'Subjects diagnosed with rheumatoid arthritis', 'interventionNames': ['Diagnostic Test: TERMOGRAPHY']}], 'interventions': [{'name': 'TERMOGRAPHY', 'type': 'DIAGNOSTIC_TEST', 'description': 'Obtaining an image of the foot using a thermographic camera', 'armGroupLabels': ['Case group: subjects with rheumatoid arthritis', 'Control group: healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41008', 'city': 'Seville', 'country': 'Spain', 'contacts': [{'name': 'RAQUEL GARCIA DE LA PEÑA DOCTOR, DOCTOR IN HEALTH SCIENCE', 'role': 'CONTACT', 'email': 'raquelgp@us.es', 'phone': '954-486-5300', 'phoneExt': '+34'}], 'facility': 'University of Seville', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'DOCTOR RAQUEL GARCIA DE LA PEÑA RAQUEL, DOCTOR IN HEALTH SCIENCE', 'role': 'CONTACT', 'email': 'raquelgp@us.es', 'phone': '9544865300', 'phoneExt': '+34'}, {'name': 'RAQUEL GARCIA DE LA PEÑA, DOCTOR IN HEALTH SCIENCE', 'role': 'CONTACT', 'email': 'raquelgp@us.es', 'phone': '9544865300', 'phoneExt': '+34'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ANA MARIA RAYO PEREZ', 'investigatorAffiliation': 'University of Seville'}}}}