Prognostic Influence of Light Rheography Measurement of Patients With Secondary Raynaud Syndrome With Ulcers on Hands

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Raynaud's Phenomenon, Skin Necrosis

Intervention / Treatment
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* Drug: Tracleer
* Drug: Prostavasin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Limited or diffuse systemic sclerosis/scleroderma with at least one ulcera at fingertip Age > 18 Years Weight > 40 Kg Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Prostavasin<br> | Drug: Prostavasin<br>* Prostavasin 60 µg i.v, 5 days per week for 2 weeks<br>* Other names: Aprostadil;|
| Active Comparator: Prostavasin + Bosentan<br> | Drug: Tracleer<br>* 14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o<br>* Other names: Bosentan;Drug: Prostavasin<br>* Prostavasin 60 µg i.v, 5 days per week for 2 weeks<br>* Other names: Aprostadil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the blood flow before, during and after the medical therapy | 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emerge of new ulcers | 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. | > 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbus Raynaud, Ulcera Hands, Toes, Vasospastic disorder, Raynaud's phenomenon