Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-27 @ 9:40 AM
Study NCT ID:
NCT03144050
Status:
UNKNOWN
Last Update Posted:
2017-05-08
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Imaging For Assessment of Foot Perfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-05', 'studyFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2017-05-05', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical risk category', 'timeFrame': 'immediate', 'description': 'risk assessment based on clinical signs'}], 'secondaryOutcomes': [{'measure': 'Ulcer incidence', 'timeFrame': '1 year', 'description': 'Ulcer formation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcer Foot', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.', 'detailedDescription': 'This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. SFDI is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. Our hypothesis is that SFDI parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. This phase of the study is designed to correlate SFDI outputs to current clinical risk categories'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any person at risk for foot ulcer formation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Pregnant/lactating women\n* Rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT03144050', 'briefTitle': 'Optical Imaging For Assessment of Foot Perfusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Modulated Imaging Inc.'}, 'officialTitle': 'Optical Imaging For Assessment of Foot Perfusion', 'orgStudyIdInfo': {'id': '11150'}}, 'armsInterventionsModule': {'armGroups': [{'label': '0', 'description': 'Control - no diabetes', 'interventionNames': ['Device: SFDI Imaging']}, {'label': '1', 'description': 'Diabetes', 'interventionNames': ['Device: SFDI Imaging']}, {'label': '2', 'description': 'Diabetes w/neuropathy', 'interventionNames': ['Device: SFDI Imaging']}, {'label': '3', 'description': 'Diabetes with vascular disease', 'interventionNames': ['Device: SFDI Imaging']}, {'label': '4', 'description': 'Diabetes w/healed ulcer', 'interventionNames': ['Device: SFDI Imaging']}, {'label': '5', 'description': 'Diabetes with current ulcer', 'interventionNames': ['Device: SFDI Imaging']}], 'interventions': [{'name': 'SFDI Imaging', 'type': 'DEVICE', 'otherNames': ['OxImager'], 'description': 'Imaging with SFDI device', 'armGroupLabels': ['0', '1', '2', '3', '4', '5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90034', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kalvin Yu, MD', 'role': 'CONTACT'}], 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Kalvin Yu, MD', 'role': 'CONTACT', 'email': 'kalvin.c.yu@kp.org', 'phone': '6264053906'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Modulated Imaging Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}