Focus On Capillaroscopic Ulcer index in Systemic sclerosis

Not Applicable

Completed

• Conditions: Systemic sclerosis; Musculoskeletal Diseases

• Registration Number: ISRCTN04371709
• Lead Sponsor: Actelion Pharma Schweiz AG (Switzerland)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30359309 (added 14/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-18
• Study Completion: 2013-02-20
• Last Update Posted: 9 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. Definitive diagnosis of systemic sclerosis (SSc) by the American College of Rheumatology (ACR) criteria
2. History of documented digital ischaemic ulcers secondary to SSc within the past year prior to enrolment or with at least one active digital ischaemic ulcer (DU) at enrolment
3. Signed patient informed consent form

Exclusion Criteria

1. Patient refused to sign the patient informed consent
2. DUs due to a condition other than SSc
3. DU associated with calcinosis
4. Treatment with parenteral prostanoids or Tracleer®) within the past 3 months before enrolment
5. Treatment with phosphodiesterase-5-inhibitors (PDE-5-I), except for intermittent treatment of male erectile dysfunction
6. Treatment with other Endothelin-receptor-antagonists (ERA)
7. Patients receiving any other experimental treatment
8. Patients receiving systemic antibiotics for infected ulcers
9. Patients with active renal crisis or advanced cardiopulmonary disease or who are otherwise clinically unstable

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Change of the capillaroscopic skin ulcer risk index (CSURI) over time with or without specific treatment<br><br> Outcomes are measured at one year<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Change of other capillaroscopic images, number of DU, appearance of new DU, change of Raynaud Condition Score, modified Rodnan skin score, amount of DU complications over time with or without specific treatment<br> 2. Correlation of the CSURI with number of DUs, Raynaud condition score and other vascular complications<br> 3. Comparison local versus central analysis of CSURI<br><br> Outcomes are measured at one year<br>