Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan
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|ClinicalTrials.gov Identifier: NCT01447550|
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : August 16, 2016
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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.
12 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.
|Condition or disease||Intervention/treatment|
|Thromboangiitis Obliterans||Drug: Bosentan|
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||Treatment of Thromboangiitis Obliterans (Buerger's Disease) With Bosentan|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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.
- Clinical improvement rate [ Time Frame: 4-6 months ]Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate
- Clinical improvement rate [ Time Frame: 4-6 months ]Clinical improvement rate (abscence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate
- Clinical improvement rate [ Time Frame: 4-6 months ]Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absense of pain), major of minor amputation rate
- haemodynamics, endothelial function and angiographic changes [ Time Frame: 4-6 months ]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).
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- Being candidates for surgical or endovascular revascularisation of the extremity studied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447550
|Hospital Universitario Getafe|
|Getafe, Madrid, Spain, 28905|
|Hospital Universitario de Getafe|
|Getafe, Spain, 28901|
|Principal Investigator:||Joaquin De Haro, MD,PhD||Hospital Universitario de Getafe|
|Responsible Party:||Joaquin de Haro, M.D., Treatment of thromboangiitis obliterans (Buergueer´s disease) with Bosentan, Hospital Universitario Getafe|
|Other Study ID Numbers:||
|First Posted:||October 6, 2011 Key Record Dates|
|Last Update Posted:||August 16, 2016|
|Last Verified:||August 2016|
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