Focus On Capillaroscopic Ulcer index in Systemic sclerosis

ISRCTN	ISRCTN04371709
DOI	https://doi.org/10.1186/ISRCTN04371709
Protocol serial number	N/A
Sponsor	Actelion Pharma Schweiz AG (Switzerland)
Funder	Actelion Pharmaceuticals

Submission date: 10/02/2011
Registration date: 18/03/2011
Last edited: 14/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Oliver Distler
Scientific

University Hospital Zürich
Gloriastrasse 25
Zürich
8091
Switzerland

Study information

Primary study design	Observational
Study design	Multicentre prospective observational non-interventional pilot study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Focus On Capillaroscopic Ulcer index in Systemic sclerosis: a national, multi-centre, prospective, observational, non-interventional pilot study
Study acronym	FOCUS
Study objectives	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(s)	Cantonal Ethics Committee Zürich, approved on 15.10.2010, KEK-ZH-Nr. 2010-0301/5
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Change of the capillaroscopic skin ulcer risk index (CSURI) over time with or without specific treatment Outcomes are measured at one year
Key secondary outcome measure(s)	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
Completion date	20/02/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Total final enrolment	61
Key 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
Key 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
Date of first enrolment	20/02/2011
Date of final enrolment	20/02/2013

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Zürich

Zürich
8091
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/10/2018	14/08/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/08/2019: Publication reference and total final enrolment number added.