Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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 analyze the effect of sildenafil on angiography.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

1. Digital gangrene, ulcers in patients with severe secondary Raynaud's phenomenon

2. 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.

3. Unchanged immunosuppressive therapy 3 months before treatment with sildenafil

4. No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy

Exclusion Criteria:

1. Therapy with iloprost during the last 4 weeks

2. Sympathectomy during the last 4 weeks

3. TIA, stroke, myocardial infarction during the last 6 months

4. Instable angina pectoris

5. Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia

6. Microangiopathic hemolytic anaemia

7. Azotaemia

8. Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists, calcium channel blockers)

9. Left ventricular ejection fraction< 20%

10. Hypotonus < 80/40 mm Hg

11. Positive pregnancy test

12. History of cancer

13. History of gastric/duodenic ulcers without endoscopic proof of complete healing

14. Participation in other studies (currently or during the last 4 weeks)

15. Abuse of alcohol or other drugs, smoker

16. Cardiac failure, use of nitrates