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Digital Ulceration (CAP)

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ClinicalTrials.gov Identifier: NCT01377090
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : July 15, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Systemic Sclerosis Digital Ulcers

Study Type : Observational
Actual Enrollment : 630 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Study Start Date : January 2011
Primary Completion Date : July 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Occurence of first new digital ulcer (DU) [ Time Frame: 6 months ]
    Occurrence of the first new digital ulcer (DU) within 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Systemic Sclerosis with or without a history of digital ulcers (DU)
Criteria

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)

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): NCT01377090


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Sponsors and Collaborators
Actelion

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01377090     History of Changes
Other Study ID Numbers: AC-052-521
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases