Prevention and Treatment of Digital Ulcers in Systemic Sclerosis
NCT ID: NCT01836263
Last Updated: 2013-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
420 participants
OBSERVATIONAL
2013-04-30
2017-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prevention arm: CCB & i.v. iloprost
prevention arm: patients receiving a combination of calcium channel blockers (CCB) and concomitant i.v. iloprost (i.v. iloprost at least in the last three months)
No interventions assigned to this group
Prevention arm: bosentan & sildenafil
prevention arm: patients receiving a combination of the endothelin receptor antagonist bosentan and the Phosphodiesterase-5 inhibitor sildenafil
No interventions assigned to this group
Healing arm: CCB & i.v. iloprost
healing arm: patients receiving a combination of calcium channel blockers (CCB) and concomitant i.v. iloprost (i.v. iloprost at least in the last three months)
No interventions assigned to this group
Healing arm: bosentan & sildenafil
healing arm: patients receiving a combination of the endothelin receptor antagonist bosentan and the Phosphodiesterase-5 inhibitor sildenafil
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
ALL
No
Sponsors
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European Union
OTHER
University of Giessen
OTHER
University of Zurich
OTHER
University of Paris 5 - Rene Descartes
OTHER
University of Campania Luigi Vanvitelli
OTHER
University of Basel
OTHER
University College, London
OTHER
Charite University, Berlin, Germany
OTHER
University of Pecs
OTHER
University of Leeds
OTHER
Schoen Klinik Hamburg Eilbek
OTHER
marco matucci cerinic
OTHER
Responsible Party
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marco matucci cerinic
Prof. Marco Matucci-Cerinic
Principal Investigators
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Marco Matucci-Cerinic, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Francesco Del Galdo, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
Ulf Müller-Ladner, Prof.
Role: STUDY_CHAIR
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Locations
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Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, , France
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, , Germany
Pecsi Tudomanyegyetem - University of Pecs
Pécs, , Hungary
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, , Italy
Policlinico, Via Pansini
Napoli-Italia, , Italy
Felix-Platter Spital, University of Basel
Basel, , Switzerland
University of Zurich, Department of Rheumatology
Zurich, , Switzerland
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, , United Kingdom
Countries
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Central Contacts
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References
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Blagojevic J, Bellando-Randone S, Abignano G, Avouac J, Cometi L, Czirjak L, Denton CP, Distler O, Frerix M, Guiducci S, Huscher D, Jaeger VK, Lorand V, Maurer B, Nihtyanova S, Riemekasten G, Siegert E, Tarner IH, Vettori S, Walker UA, Allanore Y, Muller-Ladner U, Del Galdo F, Matucci-Cerinic M; EUSTAR co-workers. Classification, categorization and essential items for digital ulcer evaluation in systemic sclerosis: a DeSScipher/European Scleroderma Trials and Research group (EUSTAR) survey. Arthritis Res Ther. 2019 Jan 24;21(1):35. doi: 10.1186/s13075-019-1822-1.
Other Identifiers
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HEALTH-F5-2012-305495-OT1
Identifier Type: -
Identifier Source: org_study_id
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