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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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.


Detailed Summary:
Sponsor: Hospital Universitario Getafe

Current Primary Outcome:

  • 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


Original Primary Outcome: Clinical improvement rate [ Time Frame: 4-6 months ]

Clinical improvement rate (absecence of new throphic lesions, ulcer healing process, pain relief, complete absecese of pain), major of minor amputation rate


Current Secondary Outcome: 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).


Original Secondary Outcome: hemodynamics,endothelial function abd 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 ant arteriography with digital substraction or an angio-magnetic resonance image (MRI).


Information By: Hospital Universitario Getafe

Dates:
Date Received: October 5, 2011
Date Started: January 2009
Date Completion:
Last Updated: August 15, 2016
Last Verified: August 2016