Prognostic Influence of Light Rheography Measurement of Patients With Secondary Raynaud Syndrome With Ulcers on Hands
Anti-Vasospasm
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedDecember 15, 2014
December 1, 2014
3.9 years
June 16, 2011
December 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Emerge of new ulcers
> 24 weeks
Study Arms (2)
Prostavasin
PLACEBO COMPARATORProstavasin + Bosentan
ACTIVE COMPARATORInterventions
14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o
Prostavasin 60 µg i.v, 5 days per week for 2 weeks
Eligibility Criteria
You may qualify if:
- Subjects with Limited or diffuse systemic sclerosis/scleroderma with at least one ulcera at fingertip
- Age \> 18 Years
- Weight \> 40 Kg
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christoph Hehrleinlead
- Actelioncollaborator
Study Sites (1)
University Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Related 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.
BACKGROUND-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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Kerber, Dr. med.
Universitätsklinik Freiburg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor Dr. med.
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 22, 2011
Study Start
July 1, 2011
Primary Completion
June 1, 2015
Study Completion
September 1, 2015
Last Updated
December 15, 2014
Record last verified: 2014-12