Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

NCT01836263 | Unknown

• 1 other identifier: HEALTH-F5-2012-305495-OT1
• Study Type: observational
• Target: 420
• Locations: 6 countries
• Sites: 11

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. 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. 2.To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria

Conditions

Systemic Sclerosis; Ulcer

Outcome Measures

Primary Outcomes (2)

• Prevention arm: Number of new digital ulcers

  24 months

• Healing arm: Time to healing of manifest digital ulcers

  24 months

Secondary Outcomes (2)

• Prevention arm: Time to development of new digital ulcers

  24 months

• Healing arm: Number of healed digital ulcers

  24 months

Other Outcomes (2)

• Prevention arm: novel composite digital ulcer prediction score

  24 months

• Healing arm: novel composite outcome score for the assessment of worsening of digital ulcers despite treatment

  24 months

Study Arms (4)

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)

Prevention arm: bosentan & sildenafil

prevention arm: patients receiving a combination of the endothelin receptor antagonist bosentan and the Phosphodiesterase-5 inhibitor sildenafil

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)

Healing arm: bosentan & sildenafil

healing arm: patients receiving a combination of the endothelin receptor antagonist bosentan and the Phosphodiesterase-5 inhibitor sildenafil

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population are adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database), the VEDOSS cohort and the jSScWG cohort

You may qualify if:

• 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.

Sponsors & Collaborators

• marco matucci cerinic: lead
• European Union: collaborator
• University of Giessen: collaborator
• University of Zurich: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• University of Basel: collaborator
• University College, London: collaborator
• Charite University, Berlin, Germany: collaborator
• University of Pecs: collaborator
• University of Leeds: collaborator
• Schoen Klinik Hamburg Eilbek: collaborator

Study Sites (11)

Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

Paris, 75014, France

RECRUITING

Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

Bad Nauheim, 61231, Germany

RECRUITING

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

Berlin, 10117, Germany

RECRUITING

Centre for Pediatric Rheumatology, Klinikum Eilbek

Hamburg, 22081, Germany

RECRUITING

Pecsi Tudomanyegyetem - University of Pecs

Pécs, H-7622, Hungary

RECRUITING

University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

Florence, 50139, Italy

RECRUITING

Policlinico, Via Pansini

Napoli-Italia, 5-80131, Italy

RECRUITING

Felix-Platter Spital, University of Basel

Basel, CH 4012, Switzerland

RECRUITING

University of Zurich, Department of Rheumatology

Zurich, 8006, Switzerland

RECRUITING

The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

Leeds, LS9 7TF, United Kingdom

RECRUITING

Royal Free Hospital, University College London

London, NW3 2QG, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 30678703 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic; Ulcer

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Matucci-Cerinic, Prof.

  University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

  PRINCIPAL INVESTIGATOR

• Francesco Del Galdo, Dr.

  The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

  PRINCIPAL INVESTIGATOR

• Ulf Müller-Ladner, Prof.

  Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

  STUDY CHAIR

Central Study Contacts

Marco Matucci-Cerinic, Prof.

CONTACT

marco.matuccicerinic@unifi.it

Francesco Del Galdo, Prof.

CONTACT

F.DelGaldo@leeds.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Marco Matucci-Cerinic

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 19, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

DE (3); HU (1); CH (2); GB (2); IT (2); FR (1)