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Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis (GRegistry SCDU)

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: NCT02798055
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : July 3, 2019
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Brief Summary:

GRegistry is a significant collection of data and information on the clinical practice of systemic scleroderma finger ulcers.

The GRegistry study is a nationwide (Greece) prospective study recording, which includes consecutive patients with SC-DU diagnosis in clinical management departments of different hospitals, selected in such a way as to reflect a representation of the country.

The use of Bosentan in the treatment of patients suffering from systemic sclerosis with digital ulcer disease is supported by data from large, placebo-controlled, randomized studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic sclerosis consistent with its beneficial effect on pulmonary arterial hypertension associated with connective tissue disease and its beneficial effect on vascular remodeling.

Condition or disease Intervention/treatment
Systematic Sclerosis Digital Ulcer Scleroderma Drug: Bosentan group

Detailed Description:

The existence and use of Patient Registries, represents one of the foundations of the progressing medical science, both for studying the natural history of diseases as well as to critically evaluate the therapeutic methods, the collection and analysis of the data from a large number of hospital units, is essential. Furthermore, the assessment of the effectiveness and adequacy of health services should be based on long-term monitoring of large groups of patients, and the assessment of the efficient functioning of the individual units, is only possible only with the availability of information for the patients of these units.

Moreover, the record of health services distribution data is a prerequisite for the design of their future development. The above led to growth of many national and international patient logs, diseases and specific treatments, the operation of which has contributed to the advancement of medical science.

Scleroderma or Systemic Sclerosis (SC) is a chronic autoimmune disease of the connective tissue with an incidence of 1: 10000- 1: 30000. In Greece it is estimated that there are approximately 2,500 patients. The disease usually affects women aged 40-60 years, and the incidence is four women to one man. The pathogenesis of the disease is unknown, while the main causes are considered genetic and environmental factors.

Two of the most critical complications of the disease, are the Pulmonary Arterial Hypertension, which occurs in patients with SC approximately 8-12% of patients, being the main cause of death, and digital ulcers that occur in 30-60 % of patients and are painful sores on the fingers. Digital ulcers, i.e. painful sores on the fingers, as a consequence of the limited blood supply of vessels are seen in approximately 30-60 % of patients with scleroderma. The digital ulcers adversely affect the quality of life of patients, even the simple daily activities and can lead to serious complications, such as amputation. The symptoms of scleroderma can vary between patients and may not be typical of this disease, at least in the early stages, making it difficult to diagnose. Two of the early symptoms are disturbance of blood supply to the extremities by a color change of the skin of the fingers, alternately pallor-cyanation-redness (Raynaud phenomenon) and rigid edematous fingers.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 148 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: A National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment.
Actual Study Start Date : September 30, 2016
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Bosentan

Primary Outcome Measures :
  1. Reynaud Severity Scale [ Time Frame: 4 months ]
  2. Number of Ulcers [ Time Frame: 4 months ]
  3. Modified Rodnan Skin Score - MRSS [ Time Frame: 4 months ]
  4. Complications of systems [ Time Frame: 4 months ]
    Number of organic systems which are affected by Systematic Scleroderma within last 4 months

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Digital Ulcers caused by Systematic Scleroderma according to ACR 2013 criteria

Inclusion Criteria:

  • Both genders >18 and < 80 years
  • ACR 2013 criteria >9 & =9
  • At least one Digital Ulcer
  • Raynaud Severity Scale (0-10)

Exclusion Criteria:

  • < 18 years
  • ACR 2013 criteria <9

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): NCT02798055

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University Clinic, Laiko Hospital
Athens, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.

Additional Information:

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Responsible Party: Elpen Pharmaceutical Co. Inc. Identifier: NCT02798055     History of Changes
Other Study ID Numbers: 2016-BSN-EL-64
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Skin Ulcer
Pathologic Processes
Skin Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action