Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

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 in patients with systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy. Consequently, there are at least three types of DU: (i) those localized at the tips of the fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management.

This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis.

Aim of this observational trial is:

1. To identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria for very early diagnosis of systemic sclerosis
2. To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria

Thus, the observational trial consist of a prevention arm and a healing arm.

Conditions

• Systemic Sclerosis
• Ulcer

Sponsors & Collaborators

• European Union

  collaborator OTHER

• University of Giessen

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• University of Paris 5 - Rene Descartes

  collaborator OTHER

• University of Campania Luigi Vanvitelli

  collaborator OTHER

• University of Basel

  collaborator OTHER

• University College, London

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University of Pecs

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• Schoen Klinik Hamburg Eilbek

  collaborator OTHER

• marco matucci cerinic

  lead OTHER

Principal Investigators

• Marco Matucci-Cerinic, Prof. · University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

• Francesco Del Galdo, Dr. · The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

• Ulf Müller-Ladner, Prof. · Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2017-06-30

Completion

2017-06-30

Countries

• France
• Germany
• Hungary
• Italy
• Switzerland
• United Kingdom

Study Locations