Digital Ulceration (CAP)

July 11, 2013 updated by: Actelion

A Multicenter, Prospective Cohort Study Using Nailfold VideoCAPillaroscopy(NVC) and Other Factors to Determine the Risk of Developing Digital Ulceration in Patients With Systemic Sclerosis (SSc)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medizinische Universität Graz
      • Vienna, Austria, 1090
        • Universitätsklinik für Innere Medizin Wien
      • Vienna, Austria, 1100
        • Sozialmedizinisches Zentrum Süd-Kaiser-Franz-Josef-Spital
      • Vienna, Austria, 1140
        • Hanusch Krankenhaus der Gebietskrankenkasse
  • Belgium
      • Brussels, Belgium, 1070
        • Université Libre de Bruxelles Hôpital Erasme
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven
  • Czech Republic
      • Prague, Czech Republic, 128 50
        • Revmatologicky ustav
  • France
      • Amiens Cedex 1, France, 80054
        • Centre Hospitalier Universitaire Amiens
      • La Tronche, France, 38700
        • Centre Hospitalier Universitaire de Grenoble
      • Lille, France, 59037
        • CHRU de Lille, hopital Claude Huriez, Service des maladies du sang
      • Limoges cedex, France, 87042
        • CHU Dupuytren
      • Nantes cedex 1, France, 44093
        • Centre Hospitalier Universitaire de Nantes
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75014
        • Groupe Hospitalier Cochin Saint Vincent de Paul
  • Germany
      • Bad Abbach, Germany, 93077
        • Asklepios Klinikum Bad Abbach
      • Bad Nauheim, Germany, 61321
        • Kerckhoff-Klinik GmbH
      • Berlin, Germany, 10117
        • Charite Universitatsmedizin Berlin
      • Bochum-Gerthe, Germany, 44805
        • Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum
      • Düsseldorf, Germany, 40225
        • Universitatsklinikum Dusseldorf
      • Halle, Germany, 06112
        • Universitätsklinikum Halle (Saale)
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona
      • Köln, Germany, 50931
        • Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
  • Greece
      • Athens, Greece, 11527
        • Laiko Hospital
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Haifa, Israel, 33394
        • Bnai Zion Medical Center
      • Kfar Saba, Israel, 49281
        • Meir Medical Center
  • Italy
      • Brescia, Italy, 25123
        • Università degli Studi di Brescia
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro
      • Genova, Italy, 16132
        • Azienda Ospedale San Martino
      • Pisa, Italy, 56126
        • Ospedale Santa Ciara
      • Roma, Italy, 00168
        • Complesso Integrato Columbus
      • Roma, Italy, 00161
        • Policlinico Umberto I
  • Netherlands
      • Amsterdam, Netherlands, 1007 MB
        • Vrije Universiteit Medisch Centrum
  • Norway
      • Lillehammer, Norway, 2609
        • Revmatismesykehuset
  • Portugal
      • Porto, Portugal, 4099-001
        • Hospital Geral de Santo Antonio
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08025
        • Hospital Sant Pau
      • Madrid, Spain, 28935
        • Hospital De Mostoles
      • Valencia, Spain, 46017
        • Hospital Doctor Peset
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Centre hospitalier universitaire vaudoise
      • Sankt Gallen, Switzerland, 9007
        • Kantonspital Sankt Gallen
      • Zurich, Switzerland, 8091
        • UniversitätsSpital Zürich
  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul Universitesi Istanbul Tip Fakultesi
  • United Kingdom
      • Bath, United Kingdom, BA1 1RL
        • Bath Institute for Rheumatic Diseases
      • Leeds, United Kingdom, LS7 4SA
        • Chapel Allerton Hospital
      • London, United Kingdom, Nw3 2QG
        • Royal Free Hospital
      • Salford, United Kingdom, M6 8HD
        • Hope Hospital
      • Wigan, United Kingdom, WN6 9EP
        • Wrightington Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Systemic Sclerosis with or without a history of digital ulcers (DU)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SSc DU-history subgroup
Systemic sclerosis patients with history of digital ulcers
SSc with No-DU-history subgroup
Systemic sclerosis patients with no history of digital ulcers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of first new digital ulcer (DU)
Time Frame: 6 months
Occurrence of the first new digital ulcer (DU) within 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 17, 2011

First Submitted That Met QC Criteria

June 17, 2011

First Posted (Estimate)

June 21, 2011

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-052-521

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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