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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01836263
Other study ID # HEALTH-F5-2012-305495-OT1
Secondary ID
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


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
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