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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Charité Universitätsmedizin Berlin
      • Bochum-Gerthe, Germany, 44805
        • Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • 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'hebrón
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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