Digital Ulceration

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01377090

Acronym

CAP

Enrollment

630

Registered

2011-06-21

Start date

2011-01-31

Completion date

2012-08-31

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digital Ulcers, Systemic Sclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Austria, Belgium, Czechia, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Portugal, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Outcome results