Debridement of digital ulcers in systemic sclerosis Skin and Connective Tissue Diseases
Conditions
Interventions
The participant will have a baseline clinical examination to assess the number, location and size of all digital ulcers. Ulcer measurements will be taken, either manually using a disposable ruler, by
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Primary diagnosis of Scleroderma (2013 ACR/EULAR classification criteria) 3. Has at least one current digital ulcer on the fingers or toes (digital ulcer defined as a denuded area with a defined border and loss of epithelialisation or loss of epidermis present on the digits, excluding those over the metacarpophalangeal joints but including ulcers derived from pitting scars (small size hyperkeratosis)) 4. Is able to self-complete the English language outcome measure tools (or complete with assistance such as family member or translator); 5. Is willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Primary diagnosis other than Scleroderma (e.g. other connective tissue disease, rheumatoid arthritis) 2. Digital ulcer derived from calcium deposits or gangrene 3. Patient is due to undergo planned surgery in the hand or foot with the digital ulcer within next 6 months; 4. Is currently participating in any Clinical Trial of an Investigational Medicine or a study in which the intervention will influence ulcer healing (as determined by the site PI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Study recruitment and the plausibility of achieving the proposed sample size for the full-scale RCT measured by summarising number of patients screened, eligible, consenting and randomised during the 18 month recruitment period 2. Study retention rates measured by proportion of questionnaires completed at week 12 and week 24 post randomisation 3. The willingness of clinicians to randomise participants, and of patients to be randomised measured via compliance recorded on clinician completed treatment logs up to and including week 24 post randomisation 4. Whether intervention delivery is achievable and acceptable to patients and practitioners; measured via clinciain completed treatment logs up to and including week 24 post randomisation 5. To explore any barriers to recruitment and how these might be overcome from the perspective of patients measured via anonymised screening forms 6. To assess the completeness of follow-up to establish how feasible it is to collect patient-reported outcome measures including data related to patient function, health status and adverse events measured at baseline, week 12 and week 24 post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient National Health Service (NHS) resource use measured at baseline, week 12 and week 24 post randomisation 2. Health Related Quality of Life (HRQoL) measured via EuroQol five dimensions (EQ-5D-5L) at baseline, week 12 and week 24 post randomisation | — |
Countries
England, United Kingdom
Outcome results
None listed