SALVE2: Scleroderma App for Lesion Verification 2

• 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 2 (SALVE2: Scleroderma App for Lesion Verification 2)

• IRAS ID

  296847

• Contact name

  Ariane Herrick

• Contact email

  ariane.herrick@manchester.ac.uk

• Sponsor organisation

  University of Manchester

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 5 months, 1 days

• Research summary

  Research Summary:

  Objective To see if patients with systemic sclerosis (SSc) can use a smartphone app to take daily photos of their digital ulcers (DUs)—and complete patient questionnaires—and whether these photos can be used as an objective way to track DU healing in clinical trials.
  Methods
  A custom app was created to collect photos and record symptom scores (pain and hand disability via the HDISS-DU questionnaire). Participants took daily photos of their DU for 30 days, which were stored securely. DU size was measured both manually and automatically (using machine learning).
  Results
  Out of 25 participants consented, 19 completed the study, providing usable data from 27 DUs. At the start, pain was moderate to high (average score 5.7/10) and disability was also significant. A total of 506 photos were analysed (about 19 per lesion).
  On day 1, average lesion area was about 12–14 mm². Over 30 days, DU size decreased slightly—about 2.4 mm² (when measured manual) and 3.0 mm² (when measured using machine learning automation). Manual and automated results correlated strongly (r = 0.81), but automated measurements were about 40% larger.
  Conclusion
  Patients with SSc were able to use the app effectively. Automated analysis of DU photos may serve as a reliable, objective outcome measure for future clinical trial

  Finger ulcers are common in patients with systemic sclerosis (also known as scleroderma), occurring in about 50% of patients. 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 the medicines perform.
  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 treatment

  However, this will involve a number of steps
  1) Designing an imaging protocol so patients can take good quality photographs of their ulcers.
  2) Designing a smartphone app that guides patients through the image capture process.
  3) Developing an automated system for analysing ulcer healing rates.

  SALVE-study 1 has previously tested the imaging protocol; SALVE study 2 will test the smartphone app.

  In order to test the smartphone app, 30 patients with systemic sclerosis related finger ulcers will be recruited. Study visits will be either face to face at Salford Royal Hospital, or remotely by video-call. At the first study visit, patients will have the app downloaded onto their smartphones. They will then be asked to image their finger ulcer(s), at home, using the smartphone app, for the next 30 days. At the second study visit, they will provide feedback regarding the smartphone app.

  SALVE study 2 will demonstrate if
  (i) The app can successfully guide patients through the image capture process.
  (ii) The app can successfully transfer images to a University of Manchester server

  If successful, further development of the app would then need to be undertaken to try and develop automated methods for analysing ulcer healing rates.
  

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  21/SW/0105

• Date of REC Opinion

  25 Aug 2021

• REC opinion

  Favourable Opinion