Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

• Conditions: Systemic Sclerosis; Ulcer

• Registration Number: NCT01836263
• Lead Sponsor: marco matucci cerinic

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-19
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-25
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 420

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 Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention arm: Number of new digital ulcers	24 months
Healing arm: Time to healing of manifest digital ulcers	24 months

Secondary Outcome Measures

Name	Time	Method
Prevention arm: Time to development of new digital ulcers	24 months
Healing arm: Number of healed digital ulcers	24 months

Trial Locations

Locations (11)

Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016; 🇫🇷 Paris, France

Felix-Platter Spital, University of Basel; 🇨🇭 Basel, Switzerland

The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital; 🇬🇧 Leeds, United Kingdom

Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology; 🇩🇪 Bad Nauheim, Germany

Policlinico, Via Pansini; 🇮🇹 Napoli-Italia, Italy

Royal Free Hospital, University College London; 🇬🇧 London, United Kingdom

Pecsi Tudomanyegyetem - University of Pecs; 🇭🇺 Pecs, Hungary

University of Zurich, Department of Rheumatology; 🇨🇭 Zurich, Switzerland

University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine; 🇮🇹 Firenze, Italy

Centre for Pediatric Rheumatology, Klinikum Eilbek; 🇩🇪 Hamburg, Germany

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