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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Freiburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Christoph Hehrlein, University of Freiburg
ClinicalTrials.gov Identifier:
NCT01378845
First received: June 16, 2011
Last updated: December 13, 2011
Last verified: December 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Freiburg:

Primary Outcome Measures:
  • Quantification of the blood flow before, during and after the medical therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tracleer
    14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o
    Other Names:
    • Tracleer
    • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Christoph Hehrlein, Professor Dr. med., University of Freiburg
ClinicalTrials.gov Identifier: NCT01378845     History of Changes
Other Study ID Numbers: 2011-002127-17
Study First Received: June 16, 2011
Last Updated: December 13, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by 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
Alprostadil
Bosentan
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on April 15, 2014