Sildenafil for Treatment of Digital Ulcers in Patients With NCT00624273

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00624273
Other study ID #	SDN-D-002G
Secondary ID	SDN-D-002G
Status	Completed
Phase	Phase 2
First received	February 14, 2008
Last updated	January 6, 2009
Start date	February 2004
Est. completion date	February 2007

Study information
Verified date	July 2003
Source	Charite University, Berlin, Germany
Contact	n/a
Is FDA regulated	No
Health authority	Germany: Ethics Commission
Study type	Interventional

Clinical Trial 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.

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 phenomenon in patients with connective tissue diseases. Probably, sildenafil has a disease-modifying capability improving different signs of a disturbed regulation of vascular tone in connective tissue diseases. Sildenafil can be used over a long period without significant side effects in scleroderma patients and improves disease severity, life quality, and prognosis of patients with connective tissue diseases and secondary Raynaud`s phenomenon.

SUBJECTS and CENTERS:

We want to study 10-15 patients with digital ulcers secondary to connective tissue diseases and which are refractory to other drugs, such as calcium channel blockers or iloprost. In this pilot study, patients are treated only in the Charité University Hospital.

INCLUSION/EXCLUSION 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

STUDY DESIGN:

This is an open prospective pilot study of one centre determining the effect of a 6 month treatment of sildenafil in patients with acral ulcers in secondary Raynaud`s phenomenon due to connective tissue diseases.

Drop out criteria's/ final points:

1 . Any change of the immunomodulating or suppressing therapy (e.g., treatment with cyclophosphamide because of an alveolitis; bolus of steroids > 30 mg/d).

2. No response on the healing of ulcers after 4 weeks of treatment with sildenafil 3. Manifestation of new ulcers/necrosis under sildenafil 4. Escalation of medication with an vascular influence (calcium channel blockers, ACE inhibitors/AT II receptor blockers)

Recruitment information / eligibility
Status	Completed
Enrollment	17
Est. completion date	February 2007
Est. primary completion date	November 2004
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years to 80 Years
Eligibility	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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil therapy
oral use

Locations
Country	Name	City	State
Germany	Riemekasten, PD Dr. med.	Berlin

Sponsors *(1)*
Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany,

Outcome
Type	Measure	Time frame	Safety issue
Primary	healing of digital ulcer	6 months	Yes
Secondary	Decrease of frequency/duration of Raynaud's attacks (monthly)	6 months	Yes
Secondary	Prevention of necroses manifestations	6 months	Yes

Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

Outcome