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Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by marco matucci cerinic, University of Florence.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01836263
First Posted: April 19, 2013
Last Update Posted: April 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
European Union
University of Giessen
University of Zurich
University of Paris 5 - Rene Descartes
University of Campania "Luigi Vanvitelli"
University of Basel
University College, London
Charite University, Berlin, Germany
University of Pecs
University of Leeds
Schoen Klinik Hamburg Eilbek
Information provided by (Responsible Party):
marco matucci cerinic, University of Florence
  Purpose

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.


Condition
Systemic Sclerosis Ulcer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months

Resource links provided by NLM:


Further study details as provided by marco matucci cerinic, University of Florence:

Primary Outcome Measures:
  • Prevention arm: Number of new digital ulcers [ Time Frame: 24 months ]
  • Healing arm: Time to healing of manifest digital ulcers [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Prevention arm: Time to development of new digital ulcers [ Time Frame: 24 months ]
  • Healing arm: Number of healed digital ulcers [ Time Frame: 24 months ]

Other Outcome Measures:
  • Prevention arm: novel composite digital ulcer prediction score [ Time Frame: 24 months ]
    Prevention: A novel composite digital ulcers prediction score which will be tested against the already proposed capillaroscopic prediction score CSURI

  • Healing arm: novel composite outcome score for the assessment of worsening of digital ulcers despite treatment [ Time Frame: 24 months ]
    Healing: A novel composite outcome score for the assessment of worsening of digital ulcers despite treatment


Estimated Enrollment: 420
Study Start Date: April 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836263


Contacts
Contact: Marco Matucci-Cerinic, Prof. marco.matuccicerinic@unifi.it
Contact: Francesco Del Galdo, Prof. F.DelGaldo@leeds.ac.uk

Locations
France
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 Recruiting
Paris, France, 75014
Principal Investigator: Yannick Allanore, Prof.         
Germany
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology Recruiting
Bad Nauheim, Germany, 61231
Principal Investigator: Ulf Müller-Ladner, Prof.         
Sub-Investigator: Ingo H. T, Dr.         
Sub-Investigator: Marc Frerix, Dr.         
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie Recruiting
Berlin, Germany, 10117
Principal Investigator: Gabriela Riemekasten, Prof.         
Centre for Pediatric Rheumatology, Klinikum Eilbek Recruiting
Hamburg, Germany, 22081
Principal Investigator: Ivan Foeldvari, Dr.         
Hungary
Pecsi Tudomanyegyetem - University of Pecs Recruiting
Pecs, Hungary, H-7622
Principal Investigator: Laszlo Czirjak, Prof.         
Italy
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine Recruiting
Firenze, Italy, 50139
Principal Investigator: Marco Matucci-Cerinic, Prof.         
Policlinico, Via Pansini Recruiting
Napoli-Italia, Italy, 5-80131
Principal Investigator: Gabriele Valentini, Prof.         
Switzerland
Felix-Platter Spital, University of Basel Recruiting
Basel, Switzerland, CH 4012
Principal Investigator: Ulrich Walker, Prof.         
University of Zurich, Department of Rheumatology Recruiting
Zurich, Switzerland, 8006
Principal Investigator: Oliver Distler, Prof.         
United Kingdom
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Francesco Del Galdo, Dr.         
Royal Free Hospital, University College London Recruiting
London, United Kingdom, NW3 2QG
Principal Investigator: Christopher Denton, Prof.         
Sponsors and Collaborators
marco matucci cerinic
European Union
University of Giessen
University of Zurich
University of Paris 5 - Rene Descartes
University of Campania "Luigi Vanvitelli"
University of Basel
University College, London
Charite University, Berlin, Germany
University of Pecs
University of Leeds
Schoen Klinik Hamburg Eilbek
Investigators
Principal Investigator: 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
Study Chair: Ulf Müller-Ladner, Prof. Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
  More Information

Responsible Party: marco matucci cerinic, Prof. Marco Matucci-Cerinic, University of Florence
ClinicalTrials.gov Identifier: NCT01836263     History of Changes
Other Study ID Numbers: HEALTH-F5-2012-305495-OT1
First Submitted: April 16, 2013
First Posted: April 19, 2013
Last Update Posted: April 25, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Sildenafil Citrate
Iloprost
Phosphodiesterase 5 Inhibitors
Bosentan
Endothelin Receptor Antagonists
Calcium Channel Blockers
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antihypertensive Agents
Platelet Aggregation Inhibitors
Membrane Transport Modulators