Digital Ulceration

Completed

• Conditions: Digital Ulcers; Systemic Sclerosis

• Registration Number: NCT01377090
• Lead Sponsor: Actelion

Brief Summary

The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-21
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-11
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

For all patients:

• Signed informed consent prior to enrollment
• Male or female, ≥ 18 years of age
• Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria

For patients with no history of digital ulcers (DU) and no DU at enrollment only:

• Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature

Exclusion Criteria

• SSc sine scleroderma (without any skin involvement)
• Patients who underwent stem cell transplantation
• Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study
• Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of first new digital ulcer (DU)	6 months	Occurrence of the first new digital ulcer (DU) within 6 months

Trial Locations

Locations (50)

Université Libre de Bruxelles Hopital Erasme; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium

Hospital Geral de Santo Antonio; 🇵🇹 Porto, Portugal

Centre Hospitalier Universitaire Vaudoise; 🇨🇭 Lausanne, Switzerland

Sozialmedizinisches Zentrum Süd-Kaiser-Franz-Josef-Spital; 🇦🇹 Vienna, Austria

Revmatologický ústav; 🇨🇿 Prague, Czech Republic

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel

Hanusch Krankenhaus der Gebietskrankenkasse; 🇦🇹 Vienna, Austria

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

UniversitätsSpital Zürich; 🇨🇭 Zurich, Switzerland

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Universitätsklinik für Innere Medizin Wien; 🇦🇹 Vienna, Austria

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Centre Hospitalier Universitaire Amiens; 🇫🇷 Amiens Cedex 1, France

Centre Hospitalier Universitaire de Grenoble; 🇫🇷 La Tronche, France

CHRU de Lille, hopital Claude Huriez, Service des maladies du sang; 🇫🇷 Lille, France

CHU Dupuytren; 🇫🇷 Limoges cedex, France

Groupe Hospitalier Cochin Saint Vincent de Paul; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes cedex 1, France

Hôpital Tenon; 🇫🇷 Paris, France

Asklepios Klinikum Bad Abbach; 🇩🇪 Bad Abbach, Germany

Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum; 🇩🇪 Bochum-Gerthe, Germany

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Germany

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Halle (Saale); 🇩🇪 Halle, Germany

Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln; 🇩🇪 Köln, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Laiko Hospital; 🇬🇷 Athens, Greece

Rambam Medical Center; 🇮🇱 Haifa, Israel

Universita degli Studi di Brescia; 🇮🇹 Brescia, Italy

Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro; 🇮🇹 Catanzaro, Italy

Azienda Ospedale San Martino; 🇮🇹 Genova, Italy

Policlinico Umberto I; 🇮🇹 Roma, Italy

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Ospedale Santa Ciara; 🇮🇹 Pisa, Italy

Revmatismesykehuset; 🇳🇴 Lillehammer, Norway

Hospital Vall D'Hebron; 🇪🇸 Barcelona, Spain

Complesso Integrato Columbus; 🇮🇹 Roma, Italy

Hospital Doctor Peset; 🇪🇸 Valencia, Spain

Hospital de Mostoles; 🇪🇸 Madrid, Spain

Kantonspital Sankt Gallen; 🇨🇭 Sankt Gallen, Switzerland

Istanbul Universitesi Istanbul Tip Fakultesi; 🇹🇷 Istanbul, Turkey

Bath Institute for Rheumatic Diseases; 🇬🇧 Bath, United Kingdom

Chapel Allerton Hospital; 🇬🇧 Leeds, United Kingdom

Hope Hospital; 🇬🇧 Salford, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

Wrightington Hospital; 🇬🇧 Wigan, United Kingdom