Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01836263
• Other study ID #: HEALTH-F5-2012-305495-OT1
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2013
• Last updated: April 24, 2013
• Start date: April 2013
• Est. completion date: June 2017

Study information

• Verified date: April 2013
• Source: University of Florence
• Contact: Marco Matucci-Cerinic, Prof.
• Email: marco.matuccicerinic[@]unifi.it
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeGermany: Ethics CommissionHungary: Institutional Ethics CommitteeFrance: Institutional Ethical CommitteeSwitzerland: EthikkommissionUnited Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis
• Ulcer

Locations

Country	Name	City	State
France	Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016	Paris
Germany	Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology	Bad Nauheim
Germany	Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie	Berlin
Germany	Centre for Pediatric Rheumatology, Klinikum Eilbek	Hamburg
Hungary	Pecsi Tudomanyegyetem - University of Pecs	Pecs
Italy	University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine	Firenze
Italy	Policlinico, Via Pansini	Napoli-Italia
Switzerland	Felix-Platter Spital, University of Basel	Basel
Switzerland	University of Zurich, Department of Rheumatology	Zurich
United Kingdom	The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital	Leeds
United Kingdom	Royal Free Hospital, University College London	London

Sponsors (12)

Lead Sponsor	Collaborator
marco matucci cerinic	Charite University, Berlin, Germany, European Union, Schoen Klinik Hamburg Eilbek, Second University of Naples, University College, London, University of Basel, University of Giessen, University of Leeds, University of Paris 5 - Rene Descartes, University of Pecs, University of Zurich

Countries where clinical trial is conducted

France,  Germany,  Hungary,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevention arm: novel composite digital ulcer prediction score	Prevention: A novel composite digital ulcers prediction score which will be tested against the already proposed capillaroscopic prediction score CSURI	24 months	No
Other	Healing arm: novel composite outcome score for the assessment of worsening of digital ulcers despite treatment	Healing: A novel composite outcome score for the assessment of worsening of digital ulcers despite treatment	24 months	No
Primary	Prevention arm: Number of new digital ulcers		24 months	No
Primary	Healing arm: Time to healing of manifest digital ulcers		24 months	No
Secondary	Prevention arm: Time to development of new digital ulcers		24 months	No
Secondary	Healing arm: Number of healed digital ulcers		24 months	No

External Links

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