Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2026-01-01 @ 11:43 AM
Study NCT ID:
NCT01111695
Status:
COMPLETED
Last Update Posted:
2011-09-30
First Post:
2010-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-29', 'studyFirstSubmitDate': '2010-04-26', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Granulation and /or epithelial tissue progression', 'timeFrame': '8 weeks', 'description': 'Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).'}], 'secondaryOutcomes': [{'measure': 'Tolerance', 'timeFrame': '8 weeks', 'description': 'Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['wound healing', 'granulation tissue', 'Varicose Ulcer'], 'conditions': ['Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be based on standardised photographs and clinical data.\n\nThe secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Chronic wounds due to arterial or venous insufficiency stages 1 to 3 and difficult to heal with the usual treatments and\n* Written informed consent\n\nExclusion Criteria:\n\n* Refuse to give written informed consent.\n* Patient suffering from mental disorder that may interfere with the treatment.\n* Known allergy or intolerance to any of the products used in the formulation.\n* Having received systemic antibiotics within 7 days of starting treatment with honey based formulation.\n* Arterial insufficiency stage IV of the lower limbs.'}, 'identificationModule': {'nctId': 'NCT01111695', 'briefTitle': 'Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Open Label Study (Phase 2) to Evaluate the Safety, Tolerance and Efficacy of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs', 'orgStudyIdInfo': {'id': 'CER 09-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Honey and ionic silver dressing', 'interventionNames': ['Device: ApisSept']}], 'interventions': [{'name': 'ApisSept', 'type': 'DEVICE', 'description': 'honey and ionic silver based dressing', 'armGroupLabels': ['Honey and ionic silver dressing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Home Care Service of the canton of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Denis Salomon, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haute école de santé - Genève', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dr Denis SALOMON/ Médecin adjoint agrégé', 'oldOrganization': 'Service de dermatologie - HUG'}}}}