Prognostic Influence of Light Rheography Measurement of Patients With Secondary Raynaud Syndrome With Ulcers on Hands (Anti-Vasospasm)

Christoph Hehrlein

Status: Unknown

Conditions: Raynaud's Phenomenon; Skin Necrosis

Treatments: Drug: Tracleer; Drug: Prostavasin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01378845

2011-002127-17

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Prostavasin

Placebo Comparator group

Treatment:

Drug: Prostavasin

Prostavasin + Bosentan

Active Comparator group

Treatment:

Drug: Prostavasin

Drug: Tracleer