Scleroderma App for Lesion Verification (SALVE) 3

• Research type

  Research Study

• Full title

  Development of a measuring app for finger lesions as an outcome measure for systemic sclerosis-related digital ulceration – Study 3

• IRAS ID

  324518

• Contact name

  Ariane Herrick

• Contact email

  ariane.herrick@manchester.ac.uk

• Sponsor organisation

  University of Manchester

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  Digital lesions (finger ulcers) are common in patients with systemic sclerosis (SSc), occurring in about 50% of cases. They are problematic because they can be painful and may lead to disability. Current treatments are not as effective as we would like, and new medicines are needed. However, clinical trials of new medicines are being hampered by inadequate ‘outcome measures’ that show us how well a medication performs. To overcome this problem, we wish to develop a smartphone app to monitor finger ulcers to see how quickly they heal. If successful, this could be used in future clinical trials, to provide accurate outcome measures, helping to identify new treatments. Additionally, the app could be used as a clinical tool to remotely monitor patient's finger ulcers, potentially reducing the number of hospital visits required.

  Previous studies (SALVE 1 and 2) have helped develop automated methods for measuring ulcer healing rates (from photographic images) based on changes in ulcer size and colour. The proposed study (SALVE 3) aims to trial the automated version of the app to determine:

  1) Feasibility of using the app in a clinical setting
  2) Patient's opinions on how the app benefits patients
  3) Clinician's opinions on how the app benefits patient

  Patients with scleroderma related finger ulcers will be recruited from Salford Royal Hospital. If they are willing to take part, they will be asked to sign a consent form and attend two study visits (either face to face or remotely).

  At the first study visit patients will be asked to complete a 'smartphone usage' questionnaire. They will then be instructed on how to use the smartphone app and asked to collect images of their ulcers (at home) using the app for the study duration.

  At the second study visit patients will be asked to complete an 'end-of-study feedback' questionnaire.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  23/SC/0214

• Date of REC Opinion

  16 Jun 2023

• REC opinion

  Favourable Opinion