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)

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.

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)