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Status:

UNKNOWN

Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

Lead Sponsor:

marco matucci cerinic

Collaborating Sponsors:

European Union

University of Giessen

Conditions:

Systemic Sclerosis

Ulcer

Eligibility:

All Genders

Brief Summary

Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Digital ulcers are frequent and have a major impact on the quality of life...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Juvenile and adult patients with diagnosis of systemic sclerosis according to the ACR/EULAR SSc criteria or the PRES/ACR/EULAR juvenile SSc criteria for enrollment into the prevention and healing arm
  • Patients with fulfilment of the preliminary criteria for very eary diagnosis of systemic sclerosis (VEDOSS criteria) for enrollment into the prevention arm
  • Patients with active digital ulcers will be allocated into the healing arm. Patients without previous or history of digital ulcers (but currently without active digital ulcers) will be allocated into the prevention arm.
  • Definition of digital ulcers (DU): DU are 1) loss of tissue, 2) DU derived from digital pitting scars and 3) DU derived from calcinosis.
  • IN THIS STUDY WE CONSIDER ONLY DU (1) LOSS OF TISSUE. THE OTHER DU (2) and DU (3) ARE REGISTERED IN THE DATA BASE IF THEY ARE PRESENT, BUT ARE EXCLUDED FROM EVALUATION.

Exclusion

    Key Trial Info

    Start Date :

    April 1 2013

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2017

    Estimated Enrollment :

    420 Patients enrolled

    Trial Details

    Trial ID

    NCT01836263

    Start Date

    April 1 2013

    End Date

    June 1 2017

    Last Update

    April 25 2013

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

    Paris, France, 75014

    2

    Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

    Bad Nauheim, Germany, 61231

    3

    Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

    Berlin, Germany, 10117

    4

    Centre for Pediatric Rheumatology, Klinikum Eilbek

    Hamburg, Germany, 22081