Prognostic influence of light rheography measurement of patients with secundary raynaud syndrome with ulcers at fingertips throughout the medicinal therapy.

Not Applicable

Recruiting

• Conditions: Skin Necrosis after secundary raynaud phenomenon; I73.0; Raynaud syndrome

• Registration Number: DRKS00003073
• Lead Sponsor: niversitätsklinik FreiburgInnere Medizin IIIKardiologie/Angiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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.