Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-27 @ 5:15 PM
Study NCT ID:
NCT01447550
Status:
COMPLETED
Last Update Posted:
2016-08-16
First Post:
2011-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013919', 'term': 'Thromboangiitis Obliterans'}], 'ancestors': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077300', 'term': 'Bosentan'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2011-10-05', 'studyFirstSubmitQcDate': '2011-10-05', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement rate', 'timeFrame': '4-6 months', 'description': 'Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate'}, {'measure': 'Clinical improvement rate', 'timeFrame': '4-6 months', 'description': 'Clinical improvement rate (abscence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate'}, {'measure': 'Clinical improvement rate', 'timeFrame': '4-6 months', 'description': 'Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absense of pain), major of minor amputation rate'}], 'secondaryOutcomes': [{'measure': 'haemodynamics, endothelial function and angiographic changes', 'timeFrame': '4-6 months', 'description': 'Hemodynamic changes as measured by means of ABI, changes in endothelial funtion as measured by means of the brachial artery flow-mediated dilation test (BAFMD) and angiographic changes as measured by means of arteriography with digital substraction or an angio-magnetic resonance image (MRI).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bosentan', 'Buerguer disease'], 'conditions': ['Thromboangiitis Obliterans']}, 'referencesModule': {'references': [{'pmid': '25217217', 'type': 'DERIVED', 'citation': "De Haro J, Bleda S, Acin F. An open-label study on long-term outcomes of bosentan for treating ulcers in thromboangiitis obliterans (Buerger's disease). Int J Cardiol. 2014 Dec 15;177(2):529-31. doi: 10.1016/j.ijcard.2014.08.107. Epub 2014 Aug 23. No abstract available."}, {'pmid': '22333218', 'type': 'DERIVED', 'citation': "De Haro J, Acin F, Bleda S, Varela C, Esparza L. Treatment of thromboangiitis obliterans (Buerger's disease) with bosentan. BMC Cardiovasc Disord. 2012 Feb 14;12:5. doi: 10.1186/1471-2261-12-5."}]}, 'descriptionModule': {'briefSummary': "This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was designed,included in which patients with ulcer and/or pain at rest were treated with bosentan p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor amputation rate, hemodynamic changes, changes in endothelial function and angiographic changes.\n\n12 patients were included were current smokers. With bosentan treatment, no new ischemic lesions were observed in all but one patient. Overall, clinical improvement was observed in 12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic resonance image an increase of distal flow was observed in 10 out of the 12 patients. All patients experienced a statistically significant improvement in their BAFMD values (means:1.8 at baseline;6.6 at the end of the treatment;12.7 three months after the end of the treatment;p\\<0.01). In conclusion: Bosentan treatment may result in an improvement of clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves further investigation in the management TAO patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients suffering from Buerger's disease", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critical ischemia in any extremity, causing pain at rest or non-healing ischemic ulcers, present for at least four weeks with no evidence of improvement in response to conventional treatment.\n\nExclusion Criteria:\n\n* Being candidates for surgical or endovascular revascularisation of the extremity studied.'}, 'identificationModule': {'nctId': 'NCT01447550', 'briefTitle': "Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan", 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Getafe'}, 'officialTitle': "Treatment of Thromboangiitis Obliterans (Buerger's Disease) With Bosentan", 'orgStudyIdInfo': {'id': 'Buerger-Bosentan'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bosentan', 'description': 'Bosentan', 'interventionNames': ['Drug: Bosentan']}], 'interventions': [{'name': 'Bosentan', 'type': 'DRUG', 'description': "Bosentan therapy consisted of a month's treatment with 62.5 mg bid orally administered. Dose doubled to 125 mg bid after the first month. The full-dose regimen (125 mg/12h) was maintained for the following months or until total healing fo the ulcers.", 'armGroupLabels': ['Bosentan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28901', 'city': 'Getafe', 'state': 'Getafe', 'country': 'Spain', 'facility': 'Hospital Universitario de Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '28905', 'city': 'Getafe', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}], 'overallOfficials': [{'name': 'Joaquin De Haro, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Getafe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Getafe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Treatment of thromboangiitis obliterans (Buergueer´s disease) with Bosentan', 'investigatorFullName': 'Joaquin de Haro, M.D.', 'investigatorAffiliation': 'Hospital Universitario Getafe'}}}}