Effect of Sildenafil on Digital Ulcers in Systemic Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- healing of digital ulcer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
1, active ulcers
sildenafil treatment
干预措施: Sildenafil therapy (Drug)
结局指标
主要结局
healing of digital ulcer
时间窗: 6 months
次要结局
- Decrease of frequency/duration of Raynaud's attacks (monthly)(6 months)
- Prevention of necroses manifestations(6 months)