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

Christoph Hehrlein30 enrolled

Overview

The purpose of this study is to evaluate the prognostic influence of light rheography measurement at the fingertips from subjects with secundary Raynaud syndrome.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Raynaud's Phenomenon Skin Necrosis

Interventions

TracleerDRUG

14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o

ProstavasinDRUG

Prostavasin 60 µg i.v, 5 days per week for 2 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 24 weeks

Secondary Outcomes

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.

Time frame: > 24 weeks

Central Contacts

Christoph Hehrlein, Prof. Dr. med.

CONTACT

+49 761 270 77090 christoph.hehrlein@uniklinik-freiburg.de

Mark Kerber, Dr. med.

CONTACT

+49 761 270 36920 mark.kerber@uniklinik-freiburg.de

Data from ClinicalTrials.gov

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