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

Raynaud's Phenomenon Clinical Trial

— Anti-Vasospasm  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01378845
• Other study ID #: 2011-002127-17
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2011
• Last updated: December 12, 2014
• Start date: July 2011
• Est. completion date: September 2015

Study information

• Verified date: December 2014
• Source: University of Freiburg
• Contact: Christoph Hehrlein, Prof. Dr. med.
• Phone: +49 761 270 77090
• Email: christoph.hehrlein[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud's Phenomenon
• Skin Necrosis

Intervention

Drug:
• Tracleer
14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o
• Prostavasin
Prostavasin 60 µg i.v, 5 days per week for 2 weeks

Locations

Country	Name	City	State
Germany	University Freiburg	Freiburg	Baden Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Christoph Hehrlein	Actelion

Country where clinical trial is conducted

Germany, 

References & Publications (2)

-Distler O, Gay S. [Scleroderma]. Internist (Berl) 2010; 51(1):30-38. -Mouthon L, Mestre-Stanislas C, Berezne A et al. Impact of digital ulcers on disability and health-related quality of life in systemic sclerosis. Ann Rheum Dis 2010; 69(1):214-217. -Denton C, Krieg T, Guillevin L. The burden of complications in patients with digital ulcers (DU) and systemic sclerosis (SSc): Preliminary findings from the DUO-Registry. 2009: 273. -Korn JH, Mayes M, Matucci CM et al. Digital ulcers in systemic sclerosis: prevention by treatment with bosentan, an oral endothelin receptor antagonist. Arthritis Rheum 2004; 50(12):3985-3993. -Block JA, Sequeira W. Raynaud's phenomenon. Lancet 2001; 357(9273):2042-2048.

-Sunderkotter C, Herrgott I, Bruckner C et al. Comparison of patients with and without digital ulcers in systemic sclerosis: detection of possible risk factors. Br J Dermatol 2009; 160(4):835-843. -Muller-Ladner U. Akrale Ischämiesyndrome: vom Raynaud-Syndrom zur systemischen Sklerose. Bremen/London/Boston: UNI-MED Verlag AG, 2009 -Arab A, Kuemmerer K, Wang J et al. Oxygenated perfluorochemicals improve cell survival during reoxygenation by pacifying mitochondrial activity. J Pharmacol Exp Ther 2008; 325(2):417-424. -Pope J, Fenlon D, Thompson A et al. Iloprost and cisaprost for Raynaud's phenomenon in progressive systemic sclerosis. Cochrane Database Syst Rev 2000;(2):CD000953. -Kawald A, Burmester GR, Huscher D et al. Low versus high-dose iloprost therapy over 21 days in patients with secondary Raynaud's phenomenon and systemic sclerosis: a randomized, open, single-center study. J Rheumatol 2008; 35(9):1830-1837. -Kowal-Bielecka O, Landewe R, Avouac J et al. EULAR recommendations for the treatment of systemic sclerosis: a report from the EULAR Scleroderma Trials and Research group (EUSTAR). Ann Rheum Dis 2009; 68(5):620-628. -Sunderkotter C, Riemekasten G. [Raynaud phenomenon in dermatology:Part 2:therapy]. Hautarzt 2006; 57(10):927-938. -Ludwig M. Angiologie in Klinik und Praxis. 1 ed. Stuttgart: Thieme Verlag, 1998; 1-334.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No