Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT01230567
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2010-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-01-15', 'releaseDate': '2013-12-02'}], 'estimatedResultsFirstSubmitDate': '2013-12-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014657', 'term': 'Vasculitis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-09', 'studyFirstSubmitDate': '2010-10-28', 'studyFirstSubmitQcDate': '2010-10-28', 'lastUpdatePostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HISTOLOGY RESULTS', 'timeFrame': '04/2013', 'description': 'HISTOLOGY RESULTS OF ALL WOUND BIOPSIES WILL BE COLLECTED TO ASSESS THE ACCULT ETIOLOGY RATE IN NON HEALING WOUNDS.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Problem wounds', 'Non healing wounds', 'BCC', 'SCC', 'Vasculitis'], 'conditions': ['Wounds and Injuries']}, 'descriptionModule': {'briefSummary': '50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult etiology for the wound.', 'detailedDescription': '25 patients suffering from non healing wounds which have non typical features for the clinical diagnosis (such as pale granulation, raised lesions and more) will undergo biopsy of the wound.\n\nAnother 25 patients suffering from non healing wounds with typical features for the clinical diagnosis will undergo biopsy of the wound.\n\nThe hypothesis is that non healing wounds harbor undiagnosed etiologic factors such as BCC, SCC, vasculitis etc. and that some clinical features should raise our suspicion for these occult etiologies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from non healing wounds, which do not respond well to six weeks of adequate treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with non-healing wounds (for \\> 6 weeks)\n* consent to be included in the study\n* age 18-85\n\nExclusion Criteria:\n\n* patients taking anti coagulant therapy\n* patients taking steroids or immunosuppressive therapy\n* pregnancy\n* pace maker'}, 'identificationModule': {'nctId': 'NCT01230567', 'briefTitle': 'Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds', 'orgStudyIdInfo': {'id': 'CMC-10-0032 CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Yaron Har-Shai, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of plastic surgery department', 'investigatorFullName': 'Yaron Har-Shai', 'investigatorAffiliation': 'Carmel Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-12-02', 'type': 'RELEASE'}, {'date': '2014-01-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yaron Har-Shai, head of plastic surgery department, Carmel Medical Center'}}}}