Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT01166893
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2010-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ability of Modulated Imaging and Laser Speckle Imaging to Determine Burn Wound Severity and Healing Potential
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081982', 'term': 'Laser Speckle Contrast Imaging'}], 'ancestors': [{'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2010-07-20', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Noninvasive burn wound severity assessment', 'timeFrame': '1 day', 'description': 'Noninvasive burn wound severity assessment using noncontact optical device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['burn wound'], 'conditions': ['Skin Burn Multiple']}, 'descriptionModule': {'briefSummary': 'According to the National Burn Repository 2007, the most common type of burn injury is a partial thickness burns. The current standard of care for partial thickness burns is two weeks of topical therapy and wound care. Burns that do not heal within two weeks undergo surgical excision and skin grafting.', 'detailedDescription': 'Researcher can use the combination of Modulated Imaging and Laser Speckle Imaging can be used as an adjuvant to standard clinical evaluation to gauge burn wound and severity of infection. Researcher can image the burn wounds of and compare with current standard of care, clinical exam, and can use the outcomes information in terms of time to healing and treatment\n\nModulating Imaging is a noninvasive optical modality measure the metabolic functions of the burn wound.\n\nLaser Speckle Imaging is a noninvasive optical modality can measure blood flow of burn wound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from University of California Irvine Medical Center Burn Unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male / female all age\n2. Subjects is an inpatient or out patient with burn wound\n\nExclusion Criteria:\n\n1. Subjects cannot lied flat and still for the duration of the imaging\n2. Subjects pregnant.'}, 'identificationModule': {'nctId': 'NCT01166893', 'briefTitle': 'Ability of Modulated Imaging and Laser Speckle Imaging to Determine Burn Wound Severity and Healing Potential', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Ability of Modulated Imaging and Laser Speckle Imaging to Determine Burn Wound Severity and Healing Potential', 'orgStudyIdInfo': {'id': '20097322'}, 'secondaryIdInfos': [{'id': 'R01GM108634', 'link': 'https://reporter.nih.gov/quickSearch/R01GM108634', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Burn wound', 'description': 'Modulated Imaging and Laser Speckle Imaging', 'interventionNames': ['Device: Modulated Imaging and Laser Speckle Imaging']}], 'interventions': [{'name': 'Modulated Imaging and Laser Speckle Imaging', 'type': 'DEVICE', 'otherNames': ['MI-LSI developed at UCI Beckman Laser Institute'], 'description': 'wound healing', 'armGroupLabels': ['Burn wound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victor Joe, MD', 'role': 'CONTACT', 'phone': '714-456-5840'}], 'facility': 'UCIMC', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Gordon Kennedy, PhD', 'role': 'CONTACT', 'email': 'gordon.kennedy@uci.edu', 'phone': '949-824-4713'}], 'overallOfficials': [{'name': 'Anthony Durkin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Director, Laboratory for Functional Imaging and Spectroscopy of Superficial Tissues', 'investigatorFullName': 'Anthony Joseph Durkin', 'investigatorAffiliation': 'University of California, Irvine'}}}}