Systemic sclerosis (SSc) with active digital ulceration (DU) Musculoskeletal Diseases
Conditions
Interventions
This study is an international multicentre longitudinal study of 100 systemic sclerosis (SSc) patients with active digital ulceration (DU) from a diverse geographic, cultural and ethnic sample of pati
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Participants will fulfil the 2013 European Union League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) classification criteria for systemic sclerosis 2. The presence of an active DU at study entry. DU shall be defined according to the World Scleroderma Foundation (WSF) as “Loss of epidermal covering with a break in the basement membrane (which separates dermis from epidermis). It appears clinically as visible blood vessels, fibrin, granulation tissue and/or underlying deeper structures (e.g., muscle, ligament, fat) or as it would appear on debridement” 3. Male or female age =18 years 4. Patient is able and willing to follow the requirements of the study, including providing informed written consent 5. Good comprehension of written and spoken English
Exclusion criteria
Exclusion criteria: 1. Pregnant women 2. Patients with a change in their vasodilator medication within the previous 2 weeks before study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity and impact of systemic sclerosis-related digital ulcers (SSc-DU) will be measured using the SSiDU questionnaire and self-administered validated questionnaires administered at baseline, week 1, week 6, week 12 and week 20. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The severity and impact of systemic sclerosis-related digital ulcers (SSc-DU) will be measured using physical examination (assessment of site and status of DU (hands), telangiectases count (hands and face), calcinosis assessment (hands, elbow and knees), mRSS) at baseline, week 6 and week 20 2. The severity and impact of systemic sclerosis-related digital ulcers (SSc-DU) will be measured using imaging (clinical photographs of DUs, nailfold capillaroscopy (two digits of each hand), thermography (fingers)) at baseline, week 6 and week 20 3. The severity and impact of systemic sclerosis-related digital ulcers (SSc-DU) will be measured using clinician assessment (DUCAS, clinician PRO VAS of DU severity and healing) at baseline, week 6 and week 20 | — |
Countries
Australia, Canada, England, United Kingdom, United States of America
Contacts
Public ContactMichael Hughes
Outcome results
None listed