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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Christoph Hehrlein, University of Freiburg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01378845
First Posted: June 22, 2011
Last Update Posted: December 15, 2014
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.
Collaborator:
Actelion
Information provided by (Responsible Party):
Christoph Hehrlein, University of Freiburg
  Purpose
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 Intervention
Raynaud's Phenomenon Skin Necrosis Drug: Tracleer Drug: Prostavasin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Christoph Hehrlein, University of Freiburg:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01378845


Contacts
Contact: Christoph Hehrlein, Prof. Dr. med. +49 761 270 77090 christoph.hehrlein@uniklinik-freiburg.de
Contact: Mark Kerber, Dr. med. +49 761 270 36920 mark.kerber@uniklinik-freiburg.de

Locations
Germany
University Freiburg Recruiting
Freiburg, Baden Württemberg, Germany, 79106
Contact: Mark Kerber, MD       mark.kerber@uniklinik-freiburg.de   
Contact: christoph Hehrlein, MD       christoph.hehrlein@uniklinik-freiburg.de   
Sponsors and Collaborators
Christoph Hehrlein
Actelion
Investigators
Principal Investigator: Mark Kerber, Dr. med. Universitätsklinik Freiburg
  More Information

Publications:
-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.

Responsible Party: Christoph Hehrlein, Professor Dr. med., University of Freiburg
ClinicalTrials.gov Identifier: NCT01378845     History of Changes
Other Study ID Numbers: 2011-002127-17
First Submitted: June 16, 2011
First Posted: June 22, 2011
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:
Raynaud Disease
Necrosis
Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Bosentan
Alprostadil
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents


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