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Prognostic Influence of Light Rheography Measurement of Patients With Secondary Raynaud Syndrome With Ulcers on Hands (Anti-Vasospasm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01378845
Recruitment Status : Unknown
Verified December 2014 by Christoph Hehrlein, University of Freiburg.
Recruitment status was:  Recruiting
First Posted : June 22, 2011
Last Update Posted : December 15, 2014
Information provided by (Responsible Party):
Christoph Hehrlein, University of Freiburg

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.

Condition or disease Intervention/treatment Phase
Raynaud's Phenomenon Skin Necrosis Drug: Tracleer Drug: Prostavasin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : July 2011
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Prostavasin Drug: Prostavasin
Prostavasin 60 µg i.v, 5 days per week for 2 weeks
Other Name: Aprostadil

Active Comparator: Prostavasin + Bosentan Drug: Tracleer
14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o
Other Name: Bosentan

Drug: Prostavasin
Prostavasin 60 µg i.v, 5 days per week for 2 weeks
Other Name: Aprostadil

Primary Outcome Measures :
  1. Quantification of the blood flow before, during and after the medical therapy [ Time Frame: 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 Outcome Measures :
  1. Emerge of new ulcers [ Time Frame: > 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01378845

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Contact: Christoph Hehrlein, Prof. Dr. med. +49 761 270 77090
Contact: Mark Kerber, Dr. med. +49 761 270 36920

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University Freiburg Recruiting
Freiburg, Baden Württemberg, Germany, 79106
Contact: Mark Kerber, MD   
Contact: christoph Hehrlein, MD   
Sponsors and Collaborators
Christoph Hehrlein
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Principal Investigator: Mark Kerber, Dr. med. Universitätsklinik Freiburg

-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.

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Responsible Party: Christoph Hehrlein, Professor Dr. med., University of Freiburg Identifier: NCT01378845     History of Changes
Other Study ID Numbers: 2011-002127-17
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014

Keywords provided by Christoph Hehrlein, University of Freiburg:
Morbus Raynaud
Ulcera Hands, Toes
Vasospastic disorder
Raynaud's phenomenon

Additional relevant MeSH terms:
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Raynaud Disease
Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents