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

Brief Title

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

Official Title

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

Brief Summary

      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.
    



Study Type

Observational


Primary Outcome

Clinical improvement rate

Secondary Outcome

 haemodynamics, endothelial function and angiographic changes

Condition

Thromboangiitis Obliterans

Intervention

Bosentan

Study Arms / Comparison Groups

 Bosentan
Description:  Bosentan

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

January 2009

Completion Date

January 2011

Primary Completion Date

January 2011

Eligibility 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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Joaquin De Haro, MD,PhD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT01447550

Organization ID

Buerger-Bosentan


Responsible Party

Principal Investigator

Study Sponsor

Hospital Universitario Getafe


Study Sponsor

Joaquin De Haro, MD,PhD, Principal Investigator, Hospital Universitario de Getafe


Verification Date

August 2016