Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-03 @ 2:27 PM
Study NCT ID:
NCT02509533
Status:
TERMINATED
Last Update Posted:
2015-07-28
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001458', 'term': 'Bandages'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'difficulties to recruit patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2015-07-27', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of healing between VAC system and compresses for all types of leg ulcers', 'timeFrame': '1 month after the transplant', 'description': 'Number of patients having a wound at least 50% of the grafted area between VAC system and compresses'}], 'secondaryOutcomes': [{'measure': 'Percentage of healing between VAC system and compresses for all types of leg ulcers', 'timeFrame': '3 months after the transplant', 'description': 'Number of patients having a wound at least 50% of the grafted area between VAC system and compresses'}, {'measure': 'Evolution of the pain by Analogic Visual Scale.', 'timeFrame': 'day 0 : just before the transplant', 'description': 'Pain score as measured by visual analog scale between VAC system and compresses'}, {'measure': 'Evolution of the pain by Analogic Visual Scale.', 'timeFrame': 'day 1 : the day after the transplant', 'description': 'Pain score as measured by visual analog scale between VAC system and compresses'}, {'measure': 'Evolution of the pain by Analogic Visual Scale', 'timeFrame': 'Month 1', 'description': 'Pain score as measured by visual analog scale between VAC system and compresses'}, {'measure': 'Quality of life questionnaire score.', 'timeFrame': 'day 0 : just before the transplant', 'description': 'Quality of life questionnaire score between VAC system and compresses'}, {'measure': 'Quality of life questionnaire score.', 'timeFrame': 'Day 5', 'description': 'Quality of life questionnaire score between VAC system and compresses'}, {'measure': 'Quality of life questionnaire score.', 'timeFrame': 'Month 1', 'description': 'Quality of life questionnaire score between VAC system and compresses'}, {'measure': 'Quality of life questionnaire score.', 'timeFrame': 'Month 3', 'description': 'Quality of life questionnaire score between VAC system and compresses'}, {'measure': 'Cost of the treatment.', 'timeFrame': 'Month 3', 'description': 'Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vacuum Assisted Closure'], 'conditions': ['Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:\n\n* A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site,\n* Consumables necessary for the implementation of the dressing,\n* Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation.\n\nThis system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient hospitalized into the dermatology unit\n* patient with an evolutive leg ulcer since more than 1 month\n* signed informed consent\n\nExclusion Criteria:\n\n* known allergy to one of dressings used in this study\n* patient with a non-treated osteomyelitis\n* patient with tumoral tissues into the wound\n* patient with raw organ or raw blood vessels\n* patient with an anticoagulation treatment with a potentially hemorrhagic curative dose\n* patient having hemostasis problems that can lead to hemorrhagic exudates'}, 'identificationModule': {'nctId': 'NCT02509533', 'briefTitle': 'Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Comparison of the Use of VAC (Vacuum Assisted Closure) System in Transplants of Leg Ulcers Versus Usual Dressing Method. A Monocentric, Prospective, Randomized, Parallel Groups Study', 'orgStudyIdInfo': {'id': '1008042'}, 'secondaryIdInfos': [{'id': '2010-A00371-38', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V.A.C.® Therapy', 'description': 'In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers.', 'interventionNames': ['Device: V.A.C.®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual dressing method (compresses)', 'description': 'In this arm, investigators will use the usual dressing method after a transplants of leg ulcers.', 'interventionNames': ['Device: dressing']}], 'interventions': [{'name': 'V.A.C.®', 'type': 'DEVICE', 'description': 'Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.', 'armGroupLabels': ['V.A.C.® Therapy']}, {'name': 'dressing', 'type': 'DEVICE', 'description': 'Patients received usual dressing method (compresses) after a transplants of leg ulcers', 'armGroupLabels': ['usual dressing method (compresses)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de SAINT-ETIENNE', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Bruno LABEILLE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de SAINT-ETIENNE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}