Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT00207818
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Cutaneous Ulcers With a Novel Biological Dressing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-10', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound closure'}], 'secondaryOutcomes': [{'measure': '% of healing at 6 months of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care'], 'conditions': ['Venous Ulcers']}, 'referencesModule': {'references': [{'pmid': '12084997', 'type': 'BACKGROUND', 'citation': 'Pouliot R, Larouche D, Auger FA, Juhasz J, Xu W, Li H, Germain L. Reconstructed human skin produced in vitro and grafted on athymic mice. Transplantation. 2002 Jun 15;73(11):1751-7. doi: 10.1097/00007890-200206150-00010.'}, {'pmid': '10476918', 'type': 'BACKGROUND', 'citation': "Michel M, L'Heureux N, Pouliot R, Xu W, Auger FA, Germain L. Characterization of a new tissue-engineered human skin equivalent with hair. In Vitro Cell Dev Biol Anim. 1999 Jun;35(6):318-26. doi: 10.1007/s11626-999-0081-x."}], 'seeAlsoLinks': [{'url': 'http://www.loex.qc.ca', 'label': 'LOEX research laboratory website'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.', 'detailedDescription': "The hypothesis of this trial is that the cutaneous model SASS, a dermal epidermal skin substitute, created by the LOEX could be as high-performant, or even better, than the one's already existent in North America for the wound care. We anticipate showing on 6 patients that ulcer that did not close with conventional treatment, will heal or at least improve with this treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men or women from 18 to 85 years old\n2. Have a venous ulcer or a mixed ulcer\n\nExclusion Criteria:\n\nDiabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy'}, 'identificationModule': {'nctId': 'NCT00207818', 'briefTitle': 'Treatment of Cutaneous Ulcers With a Novel Biological Dressing', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Treatment of Cutaneous Ulcers With a Novel Biological Dressing', 'orgStudyIdInfo': {'id': 'LOEX 005'}, 'secondaryIdInfos': [{'id': '29478 Health Canada'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'self assembled skin substitute (SASS)', 'type': 'DEVICE', 'description': 'Wound care with self assembled skin substitute (SASS)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre hospitalier affilie universitaire de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Francois A Auger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre hospitalier affilié universitaire de Québec'}, {'name': 'Lucie Germain, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre hospitalier affilié universitaire de Québec'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}