Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-20 @ 6:00 PM
Study NCT ID:
NCT03660618
Status:
TERMINATED
Last Update Posted:
2023-05-10
First Post:
2018-07-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LSFG-SKIN, Laser Speckle Flowgraphy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002056', 'term': 'Burns'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D015423', 'term': 'Scleritis'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015422', 'term': 'Scleral Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'randy-karon@uiowa.edu', 'phone': '319-356-8299', 'title': 'Dr. Randy Kardon', 'organization': 'University of Iowa Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination due to company going out of business, requested device be returned. No other companies supported this type of device. Early termination lead to only 1 subject enrolled, no analyzable data.'}}, 'adverseEventsModule': {'timeFrame': '1 year, 5 months.', 'description': 'No adverse events occurred.', 'eventGroups': [{'id': 'EG000', 'title': 'Clinic Subjects', 'description': 'cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects.\n\nlaser speckle flowgraphy: blood flow state of the skin as real time two dimensional image', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Imaging Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinic Subjects', 'description': 'cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects.\n\nlaser speckle flowgraphy: blood flow state of the skin as real time two dimensional image'}], 'timeFrame': 'One visit', 'description': 'Imaging blood flow in the tissue is of major importance in the clinical environment', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject tested before device had to be returned due to company going out of business. Data was not measurable and no repeat testing was possible as device was returned.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinic Subjects', 'description': 'cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects.\n\nlaser speckle flowgraphy: blood flow state of the skin as real time two dimensional image'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinic Subjects', 'description': 'cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects.\n\nlaser speckle flowgraphy: blood flow state of the skin as real time two dimensional image'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'female'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-05-17', 'size': 43177, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-22T16:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'This study was stopped 3/2/18 as the company who supported the device went out of business and requested the device be returned. Only 1 control subject was tested, no analyzable data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2018-07-12', 'resultsFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-09', 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Imaging Blood Flow', 'timeFrame': 'One visit', 'description': 'Imaging blood flow in the tissue is of major importance in the clinical environment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['perfusion', 'inflammatory', 'ischemia', 'lesions', 'neuropathy', 'burns', 'cancer', 'stroke'], 'conditions': ['Hypertension', 'Heart Failure', 'Vascular Ischemia', 'Burns', 'Chemotherapy Effect', 'Radiation Injuries', 'Uveitis', 'Scleritis', 'Multiple Sclerosis', 'Autonomic Neuropathy', 'Stroke', 'Intracranial Hemorrhages', 'TIA', 'Migraine', 'Headache', 'Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to quantify normal and abnormal skin blood flow regionally in different areas of the body(face, extremities, over burns and wounds) at baseline and over time in response to treatment or environmental changes, such as temperature, light and pressure.', 'detailedDescription': 'Laser speckle skin blood flow (LSFG-SKIN) will be recorded in normal subjects and in patients with disorders affecting skin capillary perfusion, which may include cardiovascular disorders, dermatologic disorders, skin wounds, ocular disorders, psychiatric disorders, and neurologic disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nControls\n\nâ—ŹHealthy normal control subjects ages 18-90\n\nCardiology Subjects\n\n* Ages 18-90\n* History of dysrhythmia, heart failure, cardiac ischemia, hypertension, peripheral vascular disease\n\nDermatology Subjects\n\n* Ages 18-90\n* History of inflammatory and cancerous lesions\n\nEndocrine Subjects\n\n* Ages 18-90\n* History of diabetes, thyroid disease\n\nNeurology Subjects\n\n* Ages 18-90\n* History of dementia, headaches, Parkinson's, light sensitivity, stroke, TIA, multiple sclerosis\n\nPsychiatry Subjects\n\n* Ages 18-90\n* History of bipolar, schizophrenia, anxiety, depression\n\nSurgery Subjects\n\n* Ages 18-90\n* History of skin wounds(trauma, chemotherapy, radiation), thermal burns, or plastic and reconstructive surgical procedures.\n\nOphthalmology Subjects\n\n* Ages 18-90\n* History of ocular disorders caused by hypo perfusion or inflammatory disorders\n\nExclusion Criteria:\n\nControls\n\n* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n* Angle closure glaucoma\n\nCardiology Subjects\n\n* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n* Angle closure glaucoma\n\n 3\\. Dermatology Subjects\n* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n* Angle closure glaucoma\n\nEndocrine Subjects\n\n* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n* Angle closure glaucoma\n\nNeurology Subjects\n\n* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n* Angle closure glaucoma\n\nPsychiatry Subjects\n\n* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n* Angle closure glaucoma\n\nSurgery Subjects\n\n* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n* Angle closure glaucoma\n\nOphthalmology Subjects\n\n* Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.\n* Angle closure glaucoma"}, 'identificationModule': {'nctId': 'NCT03660618', 'briefTitle': 'LSFG-SKIN, Laser Speckle Flowgraphy', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'LSFG-SKIN, Laser Speckle Flowgraphy', 'orgStudyIdInfo': {'id': '201702725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clinic Subjects', 'description': 'cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects.', 'interventionNames': ['Device: laser speckle flowgraphy']}], 'interventions': [{'name': 'laser speckle flowgraphy', 'type': 'DEVICE', 'description': 'blood flow state of the skin as real time two dimensional image', 'armGroupLabels': ['Clinic Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Department of Ophthalmology', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Randy Kardon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology', 'investigatorFullName': 'Randy Kardon', 'investigatorAffiliation': 'University of Iowa'}}}}