Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-18 @ 7:10 PM
Study NCT ID:
NCT02519166
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2015-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterisation of Biofilm of the Chronic Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2015-07-28', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical examination', 'timeFrame': '1 month'}, {'measure': 'characterisation of biofilm by fluorescence microscopy and confocal', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Wounds']}, 'descriptionModule': {'briefSummary': 'In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic wounds (period \\> 6 weeks) \\> 10 cm2\n* Patient age \\>18 for the 3 French centres\n* Patient participation in a follow-up program for treatment of their wound \\> 1 month\n* Availability of patient information and written informed consent from them or their legal representative\n\nExclusion Criteria:\n\n* Patients unable to submit to medical follow-up in the trial due to geographical constraints etc\n* Patients deprived of freedom or under guardianship'}, 'identificationModule': {'nctId': 'NCT02519166', 'acronym': 'Biofilm Plaie', 'briefTitle': 'Characterisation of Biofilm of the Chronic Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'orgStudyIdInfo': {'id': 'IC 2012-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with chronic wounds', 'interventionNames': ['Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing']}], 'interventions': [{'name': '1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Patients with chronic wounds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'Chu Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}