Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Focus On Capillaroscopic Ulcer index in Systemic sclerosis: a national, multi-centre, prospective, observational, non-interventional pilot study
Acronym
FOCUS
Study hypothesis
To describe the change of the capillaroscopic skin ulcer risk index during the natural course of the disease and with bosentan treatment (in patients newly needing bosentan treatment by the decision of the physician).
Ethics approval
Cantonal Ethics Committee Zürich, approved on 15.10.2010, KEK-ZH-Nr. 2010-0301/5
Study design
Multicentre prospective observational non-interventional pilot study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Systemic sclerosis
Intervention
Capillaroscopic values (amount of capillaries, amount of megacapillaries and diameter of megacapillaries) are being documented over a one year period
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Change of the capillaroscopic skin ulcer risk index (CSURI) over time with or without specific treatment
Outcomes are measured at one year
Secondary outcome measures
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
2. Correlation of the CSURI with number of DUs, Raynaud condition score and other vascular complications
3. Comparison local versus central analysis of CSURI
Outcomes are measured at one year
Overall trial start date
20/02/2011
Overall trial end date
20/02/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 - 100 participants
Total final enrolment
61
Participant 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
Recruitment start date
20/02/2011
Recruitment end date
20/02/2013
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Zürich
Zürich
8091
Switzerland
Sponsor information
Organisation
Actelion Pharma Schweiz AG (Switzerland)
Sponsor details
Stadtturmstrasse 5
Baden
5400
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Actelion Pharmaceuticals
Alternative name(s)
Actelion Pharmaceuticals Ltd
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30359309 (added 14/08/2019)