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

NCT ID: NCT01378845

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Raynaud's Phenomenon Skin Necrosis

Keywords

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Morbus Raynaud Ulcera Hands, Toes Vasospastic disorder Raynaud's phenomenon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prostavasin

Group Type PLACEBO_COMPARATOR

Prostavasin

Intervention Type DRUG

Prostavasin 60 µg i.v, 5 days per week for 2 weeks

Prostavasin + Bosentan

Group Type ACTIVE_COMPARATOR

Tracleer

Intervention Type DRUG

14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o

Prostavasin

Intervention Type DRUG

Prostavasin 60 µg i.v, 5 days per week for 2 weeks

Interventions

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Tracleer

14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o

Intervention Type DRUG

Prostavasin

Prostavasin 60 µg i.v, 5 days per week for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Bosentan Aprostadil

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role collaborator

Christoph Hehrlein

OTHER

Sponsor Role lead

Responsible Party

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Christoph Hehrlein

Professor Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mark Kerber, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik Freiburg

Locations

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University Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christoph Hehrlein, Prof. Dr. med.

Role: CONTACT

Phone: +49 761 270 77090

Email: [email protected]

Mark Kerber, Dr. med.

Role: CONTACT

Phone: +49 761 270 36920

Email: [email protected]

Facility Contacts

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Mark Kerber, MD

Role: primary

christoph Hehrlein, MD

Role: backup

References

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-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.

Reference Type 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.

Reference Type BACKGROUND

Other Identifiers

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2011-002127-17

Identifier Type: -

Identifier Source: org_study_id