Condition category
Musculoskeletal Diseases
Date applied
10/02/2011
Date assigned
18/03/2011
Last edited
18/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Oliver Distler

ORCID ID

Contact details

University Hospital Zürich
Gloriastrasse 25
Zürich
8091
Switzerland

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 measures

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

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

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

http://www.actelion.com/en/index.page

Funders

Funder type

Industry

Funder name

Actelion Pharma Schweiz AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes