Monocenter, IIT, Open Controlled and Prospectiv Study to Define the Prognostic Influence of Light Rheography Measurement of Patients With Secundary Raynaud Syndrome With Ulcers at Fingertips Throughout the Medicinal Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quantification of the blood flow before, during and after the medical therapy
研究概览
简要总结
The purpose of this study is to evaluate the prognostic influence of light rheography measurement at the fingertips from subjects with secundary Raynaud syndrome.
详细描述
Digital Ulcers (DU) belong to one of the most prevalent complications of systemic scleroses, leading in course to considerable impairment in everyday and professional life. The aetiology of the emergence of DU in patients with systemic scleroses (SSc) is complex, whereas the disease itself is primarily characterized by a vasculopathy of the small arterial vessels. In the course of the disease this chronic infection leads to fibrotic intimal hyperplasia, adventitial fibrosis, and thus to a significant lumen narrowing. So far, a number of independent risk factors have been identified, such as male gender, chronic infections of the esophagus, pulmonary-arterial hypertension, evidence of specific antibodies (e.g. anti-Scl70) in the blood, or the a previous manifestation of a Raynoud Syndrom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Limited or diffuse systemic sclerosis/scleroderma with at least one ulcera at fingertip
- •Age > 18 Years
- •Weight > 40 Kg
排除标准
- •Sympathectomy
- •Ulcers due to other condition (PVD, DM, Thromboangiitis obliterans etc.)
- •Antibiotic concomitant medication
- •Therapy with Prostanoids within the last 4 weeks
- •Previous Bosentan therapy
- •Severe liver and renal insufficiency(creatinin >2.0 mg/dl;AST/ALT > 3X UNL)
- •severe cardiac- pulmonal diseases
- •Untreated or therapy refractory Hypertension
- •Noncompliance
- •Pregnancy or nursing (Pregnancy test required)
研究组 & 干预措施
Prostavasin
干预措施: Prostavasin (Drug)
Prostavasin + Bosentan
干预措施: Tracleer (Drug)
Prostavasin + Bosentan
干预措施: Prostavasin (Drug)
结局指标
主要结局
Quantification of the blood flow before, during and after the medical therapy
时间窗: 24 weeks
The primary objective of this study is defined by the dynamics of the (post)capillary blood flow before (baseline value) and 12 weeks after treatment, measured by means of the LRR. In doing so, the therapeutic effect, in terms of the change in (post)capillary blood flow after treatment compared to baseline value, is to be quantitatively determined.
次要结局
- Emerge of new ulcers(> 24 weeks)
研究者
Christoph Hehrlein
Professor Dr. med.
University of Freiburg