Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joaquin de Haro, M.D., Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01447550
First received: October 5, 2011
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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 Intervention
Thromboangiitis Obliterans
Drug: Bosentan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Thromboangiitis Obliterans (Buerger's Disease) With Bosentan

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Getafe:

Primary Outcome Measures:
  • Clinical improvement rate [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absense of pain), major of minor amputation rate


Secondary Outcome Measures:
  • haemodynamics, endothelial function and angiographic changes [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 12
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bosentan
Bosentan
Drug: Bosentan
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.
Other Name: Bosentan

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Being candidates for surgical or endovascular revascularisation of the extremity studied.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01447550

Locations
Spain
Hospital Universitario Getafe
Getafe, Madrid, Spain, 28905
Hospital Universitario de Getafe
Getafe, Spain, 28901
Sponsors and Collaborators
Hospital Universitario Getafe
Investigators
Principal Investigator: Joaquin De Haro, MD,PhD Hospital Universitario de Getafe
  More Information

No publications provided by Hospital Universitario Getafe

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joaquin de Haro, M.D., Treatment of thromboangiitis obliterans (Buergueer´s disease) with Bosentan, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01447550     History of Changes
Other Study ID Numbers: NCT03112011
Study First Received: October 5, 2011
Last Updated: October 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Hospital Universitario Getafe:
Bosentan
Buerguer disease

Additional relevant MeSH terms:
Thromboangiitis Obliterans
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases
Vasculitis
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014