Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-04-22 @ 5:23 PM
Study NCT ID:
NCT02385903
Status:
TERMINATED
Last Update Posted:
2016-12-01
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial on the Use of Flammacerium in Necrotic Arterial Wounds of the Lower Limb Versus Standard Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C046337', 'term': 'cerous nitrate, sulfadiazine silver drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'whyStopped': 'Decision of the Independent Review Committee', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2015-02-24', 'studyFirstSubmitQcDate': '2015-03-10', 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amputation rate', 'timeFrame': '6 months', 'description': 'Level of amputation'}], 'secondaryOutcomes': [{'measure': 'Infection rate', 'timeFrame': '6 months'}, {'measure': 'Wound size', 'timeFrame': '6 months'}, {'measure': 'Pain during dressing (VAS)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Flammacerium', 'Ischemic wound', 'Lower limb', 'Arteriopathy', 'Amputation', 'Dressing'], 'conditions': ['Ischemic Wound of the Lower Limb', 'Necrotic Arterial Wounds']}, 'descriptionModule': {'briefSummary': 'Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic wound of the lower limb\n* Minimum 50% necrosis\n* Arteriopathy with ABI\\<0.7 or \\>1.3 with radiographic examinations\n* No revascularisation procedure possible for any reasons\n* No urgent amputation need\n* Amputation considered in a short term\n* Non life-threatened patients\n\nExclusion Criteria:\n\n* Sulphonamide hypersensibility\n* Propyleneglycols hypersensibility\n* Enzyme glucose deshydrogenase deficiencies\n* Others studies participation\n* Tutorship or curatoship'}, 'identificationModule': {'nctId': 'NCT02385903', 'acronym': 'Flammacérium', 'briefTitle': 'Randomized Controlled Trial on the Use of Flammacerium in Necrotic Arterial Wounds of the Lower Limb Versus Standard Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'orgStudyIdInfo': {'id': '8546'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard dressing procedure', 'description': 'One arm receive standard dressing procedure according to the wound', 'interventionNames': ['Other: Standard dressing procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flammacerium', 'description': 'Necrosis covering with Flammacerium 3 mm thick each day during one week then one day on two.\n\nOn each dressing, remove excess and add flammacerium. Not to remove crust forming until eliminating furrow appears.\n\nCover Flammacerium by compress.', 'interventionNames': ['Other: Flammacerium']}], 'interventions': [{'name': 'Flammacerium', 'type': 'OTHER', 'armGroupLabels': ['Flammacerium']}, {'name': 'Standard dressing procedure', 'type': 'OTHER', 'armGroupLabels': ['Standard dressing procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Wound healing Department', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rangueil Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Caen', 'class': 'OTHER'}, {'name': 'Beziers Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}