Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT01249495
Status:
UNKNOWN
Last Update Posted:
2010-12-10
First Post:
2010-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007871', 'term': 'Leg Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-09', 'studyFirstSubmitDate': '2010-11-25', 'studyFirstSubmitQcDate': '2010-11-26', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.", 'timeFrame': '01.08.10-01.08.13', 'description': 'Wound size'}], 'secondaryOutcomes': [{'measure': "Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation.", 'timeFrame': '01.08.10-01.08.13', 'description': 'Pro-inflammatory cytokines'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['leg ulcer', 'wound therapy', 'Pro-inflammatory interleukins'], 'conditions': ['Treatment of Leg Ulcer', 'Sharp Debridement', 'Proinflammatory Cytokines']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the rate of wound healing using sharp debridement using curette and to compare between such intensive treatment at hospital and treatment in primary care. A correlation between change in wound size and pro-inflammatory cytokines will also be made.', 'detailedDescription': 'Subjects with chronic venous leg ulcers are treated 3 times a week in the hospital for 6 weeks with weekly sharp debridement. Wound size, pro-inflammatory cytokines, smears and photo are made weekly. The treatment countinue thereafter in primary care 3 times a week in 12 weeks. Wound size, pro-inflammatory cytokines, smears and photo are made every 14 day at the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ulcus cruris venosoum\n* AAI \\> 0.9\n* age 18-80\n* adress Oslo area\n* wound size 2.5-100 cm2\n* wound duration \\> 6 weeks.\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Immunosuppresion\n* antibiotics \\< 14 days\n* local antiseptic treatment \\< 1 week\n* clinical infection.'}, 'identificationModule': {'nctId': 'NCT01249495', 'briefTitle': "Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation", 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': "Treatment of Chronic Legg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation", 'orgStudyIdInfo': {'id': '2010/736-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sharp debridement', 'type': 'PROCEDURE', 'description': 'After use of local anestetics a sharp currette is used to debride slough and nonviable tissue from the ulcer surface until a healthy tissue is seen.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Tone Kristin Bergersen, MD, PhD', 'role': 'CONTACT', 'email': 'kristin.bergersen@rikshospitalet.no', 'phone': '+ 47 95 277 814'}, {'name': 'Tone K Bergersen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oslo University Hospital, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Tone K Bergersen, MD;PhD', 'role': 'CONTACT', 'email': 'kristin.bergersen@rikshospitalet.no', 'phone': '+47 22725829'}, {'name': 'Brita Pukstad, MD', 'role': 'CONTACT', 'email': 'brita.pukstad@ntnu.no', 'phone': '+47 95878012'}], 'overallOfficials': [{'name': 'Tone K Bergersen, MD;PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital;Dermatologic Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Aker', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Tone Kristin Bergersen', 'oldOrganization': 'Oslo University hospital, Rikshospitalet, Dermatologic Department'}}}}