Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-01-05 @ 6:19 PM
Study NCT ID:
NCT00634868
Status:
TERMINATED
Last Update Posted:
2011-06-10
First Post:
2008-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Wounds Utilizing Light
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'Slow patients recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-09', 'studyFirstSubmitDate': '2008-02-07', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The wound healing process', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ulcer wound diabetes'], 'conditions': ['Diabetic Ulcer']}, 'descriptionModule': {'briefSummary': 'The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has 8 weeks venus leg ulcer.\n* The ulcer was not better on prior treatment of various medical clinics.\n* The patient has diabetic ulcer grade 1 or 2\n\nExclusion Criteria:\n\n* Patient has severe infection.\n* Patient is taking antibiotic\n* Patient has ankle brachial index less than 0.7\n* Patient is schedule to undergone revascularization surgery 10 weeks before the study\n* Patient has photosensitive disease\n* Patient has cancer\n* Creatinine level is more than 2 mg%\n* Patient is taking immunosuppressive medication.\n* Pregnant women\n* Dialysis patient\n* Anaemic patients(less than 9 gr)\n* Patient has Albumin level less than 3 mg%'}, 'identificationModule': {'nctId': 'NCT00634868', 'briefTitle': 'Treatment of Wounds Utilizing Light', 'organization': {'class': 'INDUSTRY', 'fullName': 'QRay Ltd.'}, 'orgStudyIdInfo': {'id': 'or003121107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': '1', 'description': 'The device is emitting a sham light', 'interventionNames': ['Device: Qray light therapy device-Sham']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'The device is emitting curative light', 'interventionNames': ['Other: Qray light therapy device']}], 'interventions': [{'name': 'Qray light therapy device', 'type': 'OTHER', 'description': 'The light is filtered from harmful UV and InfraRed light and only light at wavelight of 405nm until 1000nm is delivered.', 'armGroupLabels': ['2']}, {'name': 'Qray light therapy device-Sham', 'type': 'DEVICE', 'description': 'non curative light- the device emits the same broad light, but with very low intensity', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QRay Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Qray Ltd', 'oldOrganization': 'Qray'}}}}