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)

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Universitätsklinik für Innere Medizin Wien; 🇦🇹 Vienna, Austria

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

Hanusch Krankenhaus der Gebietskrankenkasse; 🇦🇹 Vienna, Austria

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

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium

Revmatologický ústav; 🇨🇿 Prague, Czech Republic

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

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

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