Focus On Capillaroscopic Ulcer index in Systemic sclerosis
| ISRCTN | ISRCTN04371709 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04371709 |
| Secondary identifying numbers | N/A |
- 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
Scientific
University Hospital Zürich
Gloriastrasse 25
Zürich
8091
Switzerland
Study information
| Study design | Multicentre prospective observational non-interventional pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 20/02/2011 |
| Completion date | 20/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 - 100 participants |
| 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
8091
Switzerland
Sponsor information
Actelion Pharma Schweiz AG (Switzerland)
Industry
Industry
Stadtturmstrasse 5
Baden
5400
Switzerland
| Website | http://www.actelion.com/en/index.page |
|---|---|
"ROR" |
https://ror.org/001yedb91 |
Funders
Funder type
Industry
Actelion Pharmaceuticals
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Actelion Pharmaceuticals Ltd
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
14/08/2019: Publication reference and total final enrolment number added.
