Optimising the assessment and novel mechanistic insights into digital ulcers in systemic sclerosis: the international ‘100 DU’ study
Systemic sclerosis (SSc) with active digital ulceration (DU)
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 patients enrolled from 15 English-speaking Scleroderma Clinical Trials Consortium (SCTC) sites in the UK, US, Australasia, and Canada. Observations to be made include questionnaires, clinician assessment, clinical photography and thermal imaging. To achieve our study aims, we have designed an international multicentre longitudinal study of 100 SSc patients with active DU from a diverse geographic, cultural and ethnic sample of patients enrolled from 15 English-speaking SCTC sites in the UK and US. The ‘100DU’ study will facilitate the comprehensive capture of patient-reported, clinician-assessed and imaging (photography and nailfold capillaroscopy) data from 100 SSc patients with active DU (including ischaemic, extensor and calcinosis-related ulceration) over 20 weeks. Applicable regulatory frameworks shall be adhered to at each participating unit, with local PIs retaining responsibility for local IRB approval and adherence to good practice. Data sharing MTAs shall be established between sites. The pragmatic study design shall include clinician assessments at 4-8 weeks and 18-22 weeks (attempting to mirror clinical practice) and benefit from self-administered PRO questionnaire completion at home. Patients will complete the study when/if their DU have been considered to have healed by their practising clinician. Participants will be consented and complete all self-administered questionnaires using the REDCap electronic data capture software. Clinicians will complete the case report form(s). The SSiDU questionnaire is a preliminary item bank comprising 29 items developed with the support of patient insight partners. Each item is grounded in the 5 major themes that encapsulate the patient experience of SSc-DU identified in our earlier literature review and qualitative
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
1. Pregnant women 2. Patients with a change in their vasodilator medication within the previous 2 weeks before study entry