Prognostic Influence of Light Rheography Measurement of Patients With Secondary Raynaud Syndrome With Ulcers on Hands
- Conditions
- Raynaud's PhenomenonSkin Necrosis
- Interventions
- Drug: Prostavasin
- Registration Number
- NCT01378845
- Lead Sponsor
- Christoph Hehrlein
- Brief Summary
The purpose of this study is to evaluate the prognostic influence of light rheography measurement at the fingertips from subjects with secundary Raynaud syndrome.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Subjects with Limited or diffuse systemic sclerosis/scleroderma with at least one ulcera at fingertip
- Age > 18 Years
- Weight > 40 Kg
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prostavasin Prostavasin - Prostavasin + Bosentan Prostavasin - Prostavasin + Bosentan Tracleer -
- Primary Outcome Measures
Name Time Method Quantification of the blood flow before, during and after the medical therapy 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.
- Secondary Outcome Measures
Name Time Method Emerge of new ulcers > 24 weeks Additionally, it is to be examined if new DUs emerge after 24 weeks or not. The prospects for recovery of the DU will be investigated by means of visual analogue scale (VAS), photo-documentation, and D-LRR after 2, 6, 12, and 24 weeks of medicinal therapy. Furthermore, as mentioned above, the change in the HIF-1alpha gene expression before (baseline value) and 6 weeks after treatment is to be analyzed.
Trial Locations
- Locations (1)
University Freiburg
🇩🇪Freiburg, Baden Württemberg, Germany