Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-26 @ 1:35 PM
Study NCT ID:
NCT01139567
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2010-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Perfusion and Blood Flow Monitoring Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-28', 'studyFirstSubmitDate': '2010-05-27', 'studyFirstSubmitQcDate': '2010-06-05', 'lastUpdatePostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of blood flow velocity measurements of wound sites to assess tissue viability with a novel optical device. Comparison between the responses of patients treated with hyperbaric oxygen therapy and those treated by other means will be made.', 'timeFrame': '2 years'}]}, 'conditionsModule': {'keywords': ['Diabetic Wounds', 'Hyperbaric Oxygen', 'Laser Speckle Imaging', 'Hyperbaric Oxygenation'], 'conditions': ['Wounds and Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. The hypothesis is that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who have chronic lower extremity wounds will be recruited from the patient population at the Chippenham and Johnston-Willis Medical Center (CJW) for enrollment in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements:\n\n * neuropathic diabetic foot ulcer\n * soft tissue radiation necrosis\n * crush injury\n * compromised/failed skin grafts and flaps\n* Subjects must have signed the Informed Consent Forms.\n\nExclusion Criteria\n\n* Subjects who are not candidates for HBO therapy for any reason, including but not limited to: untreated pneumothorax, uncontrolled congestive heart failure, seizure disorder, neoplastic tumors, claustrophobia (for those in the HBO Group).\n* Female subjects who are pregnant or nursing.\n* Anyone who is unable to give written informed consent.\n* Subjects with end-stage renal disease or who require peritoneal or hemodialysis.\n* Subjects with current malignancies.'}, 'identificationModule': {'nctId': 'NCT01139567', 'acronym': 'WoundImager', 'briefTitle': 'Tissue Perfusion and Blood Flow Monitoring Technology', 'organization': {'class': 'INDUSTRY', 'fullName': 'CW Optics, Inc.'}, 'officialTitle': 'Tissue Perfusion and Blood Flow Monitoring Technology', 'orgStudyIdInfo': {'id': 'WoundImager-2010-01'}, 'secondaryIdInfos': [{'id': '5R44HL059807-06', 'link': 'https://reporter.nih.gov/quickSearch/5R44HL059807-06', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard Care Group', 'description': 'Subjects who will undergo only standard wound care management.'}, {'label': 'Hyperbaric Oxygen Therapy Group', 'description': 'Subjects who are selected for adjunctive hyperbaric oxygen therapy in addition to standard wound care intervention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Chippenham and Johnston-Willis Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CW Optics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}