SALVE: Scleroderma App for Lesion VErification (Study 1)
Research type
Research Study
Full title
Development of a measuring app for finger lesions as an outcome measure for systemic sclerosis-related digital ulceration (SALVE: Scleroderma App for Lesion VErification) (Study 1)
IRAS ID
275971
Contact name
Ariane Herrick
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Digital lesions (finger or toe ulcers) are common in the multisystem connective tissue disease, systemic sclerosis, occurring in about 50% of patients, and are problematic because they are painful and disabling. Current treatments are not as effective as we would like and new therapies are urgently needed. However, clinical trials of new drugs are currently being hampered by inadequate ‘outcome measures’ – indicators of how well a drug performs in clinical trials.
To overcome this problem we wish to develop a smartphone app to monitor digital lesions over time and provide a tool for assessing digital lesion healing rates. If successful, this could be used in future clinical trials to provide accurate outcome measures and ultimately aid in the discovery of effective new treatments for digital lesions. This will involve three key stages:
1 Develop an imaging protocol for patients to photograph or video their digital lesions.
2. Develop a smartphone app that guides patients through the image capture process.
3. Develop automated methods of analysis to monitor digital lesion healing rates.
This study will be limited to the development and testing of the imaging protocol. A second study will cover the development and testing of the smartphone app (and will have it's own separate ethics application)
To develop and test the imaging protocol, 30 patients with systemic sclerosis related digital lesions will be recruited. At their first study visit they will be consented and have the imaging protocol explained. They will then image their digital lesion(s) daily for about 30 days before returning for a second study visit. They will be asked to provide imaging protocol feedback. The images recorded and feedback received will help refine the imaging protocol and inform future smartphone app development.
Recruitment and study visits will take place at Salford Royal Hospital and funding is being provided by Versus Arthritis
REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0674
Date of REC Opinion
12 May 2020
REC opinion
Further Information Favourable Opinion