Status:
COMPLETED
Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Active Digital Ulcers
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and a...
Detailed Description
INVESTIGATOR: Dr. Gabriela Riemekasten Anke Praast Prof. G. R. Burmester Prof. Falk Hiepe OBJECTIVES: Sildenafil is a very potent drug in the treatment of digital ulcers secondary to Raynaud´s pheno...
Eligibility Criteria
Inclusion
- Digital gangrene, ulcers in patients with severe secondary Raynaud's phenomenon
- Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil.
- Unchanged immunosuppressive therapy 3 months before treatment with sildenafil
- No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy
Exclusion
- Therapy with iloprost during the last 4 weeks
- Sympathectomy during the last 4 weeks
- TIA, stroke, myocardial infarction during the last 6 months
- Instable angina pectoris
- Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia
- Microangiopathic hemolytic anaemia
- Azotaemia
- Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists, calcium channel blockers)
- Left ventricular ejection fraction\< 20%
- Hypotonus \< 80/40 mm Hg
- Positive pregnancy test
- History of cancer
- History of gastric/duodenic ulcers without endoscopic proof of complete healing
- Participation in other studies (currently or during the last 4 weeks)
- Abuse of alcohol or other drugs, smoker
- Cardiac failure, use of nitrates
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00624273
Start Date
February 1 2004
End Date
February 1 2007
Last Update
January 7 2009
Active Locations (1)
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1
Riemekasten, PD Dr. med.
Berlin, State of Berlin, Germany, 10117