Focus On Capillaroscopic Ulcer index in Systemic sclerosis

Focus On Capillaroscopic Ulcer index in Systemic sclerosis: a national, multi-centre, prospective, observational, non-interventional pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN04371709

Enrollment

100

Registered

2011-03-18

Start date

2011-02-20

Completion date

Unknown

Last updated

2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic sclerosis Musculoskeletal Diseases Systemic sclerosis

Interventions

Capillaroscopic values (amount of capillaries, amount of megacapillaries and diameter of megacapillaries) are being documented over a one year period

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change of the capillaroscopic skin ulcer risk index (CSURI) over time with or without specific treatment Outcomes are measured at one year	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026