Raynaud's Phenomenon, Skin Necrosis
Conditions
Keywords
Morbus Raynaud, Ulcera Hands, Toes, Vasospastic disorder, Raynaud's phenomenon
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.
Interventions
DRUGTracleer
14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o
DRUGProstavasin
Prostavasin 60 µg i.v, 5 days per week for 2 weeks
Sponsors
Actelion
Christoph Hehrlein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Contacts
Primary ContactChristoph Hehrlein, Prof. Dr. med.
Backup ContactMark Kerber, Dr. med.
Outcome results
None listed