Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT02583958
Status:
UNKNOWN
Last Update Posted:
2015-10-22
First Post:
2015-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2015-10-12', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative regression of wound surface area', 'timeFrame': 'week 20'}], 'secondaryOutcomes': [{'measure': 'Percentage of debrided wounds', 'timeFrame': 'at each clinical evaluation up to 20 weeks'}, {'measure': 'Occurrence of adverse events as assessed by the investigator according to a classification MedDRA', 'timeFrame': 'between inclusion and week 20'}, {'measure': "Patient's Quality of Life", 'timeFrame': 'at inclusion visit and at week 20 or at the end of study treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Leg Ulcers']}, 'descriptionModule': {'briefSummary': 'Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years old who has provided his/her written informed consent,\n* Patient who can be monitored by the same investigation team throughout the whole duration of the study,\n* Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,\n* Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,\n* Ulcer area \\> or equal to 5cm2,\n* Ulcer duration \\> or equal to 6 months,\n* Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,\n* Moderately or heavily exudative ulcers.\n\nExclusion Criteria:\n\n* Clinical infection on the wound bed.'}, 'identificationModule': {'nctId': 'NCT02583958', 'briefTitle': 'Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires URGO'}, 'officialTitle': 'Assessment of Efficacy and Safety for a New Wound Dressing URGO 310 3166 in the Local Treatment of Venous or Mixed Leg Ulcers: A European, Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'FI-14-06-310 3166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device Urgo 3103166', 'description': 'Soft-adherent hydro-desloughing dressing', 'interventionNames': ['Device: Urgo 3103166']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Device Aquacel Extra', 'description': 'Hydrofibre dressing', 'interventionNames': ['Device: Aquacel Extra']}], 'interventions': [{'name': 'Urgo 3103166', 'type': 'DEVICE', 'description': "URGO 310 3166 dressing should be changed as often as required (let to the Investigator's convenience). The dressing change frequency is based on the exudate level and the clinical progress of the wound (up to 7 days).", 'armGroupLabels': ['Device Urgo 3103166']}, {'name': 'Aquacel Extra', 'type': 'DEVICE', 'description': 'Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.', 'armGroupLabels': ['Device Aquacel Extra']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie Meaume, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Sylvie Meaume, MD', 'role': 'CONTACT', 'email': 'sylvie.meaume@rth.aphp.fr'}], 'overallOfficials': [{'name': 'Sylvie Meaume, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Rothschild - Paris - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires URGO', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}