Digital Ulceration

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Digital Ulcers Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Graz, Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Occurence of first new digital ulcer (DU)

Time frame: 6 months

Occurrence of the first new digital ulcer (DU) within 6 months

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study 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)

Acronym: CAP

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 21, 2011
Registry last updated: Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed