SATISS
Research type
Research Study
Full title
Sensitivity Analysis of Thermal Imaging in Systemic Sclerosis-related digital vasculopathy (SATISS)
IRAS ID
297744
Contact name
Andrea Murray
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Much of the pain and disability of systemic sclerosis (SSc) relates to Raynaud's phenomenon (RP), which can have a major impact on quality of life. RP often progresses to painful digital ulcers, and can sometimes lead to gangrene which requires amputation. There is a lack of objective measures to look at treatment response in clinical trials, and current treatments are only poorly effective. Non-invasive, objective imaging techniques, such as thermography (imaging skin temperature) offers a way forward here.
The aim of this five-centre, international collaborative project is to test the hypotheses that thermography measurements in response to a laboratory-based cold challenge test (where the hands are exposed to 15 degree water for one minute) and home-based thermography imaging, are sufficiently sensitive to detect clinically-relevant blood flow changes induced by vasodilators. The study will recruit 60 patients with SSc-related RP who will attend three laboratory-based visits over a period of approximately one month. In addition, they will carry out thermal self-imaging of their hands at home, to enable investigation of a low-cost, portable version of thermography which could revolutionise finger blood flow monitoring in patient studies. Once completed, the study will provide full validation of a new, objective, gold-standard cold challenge technique for application in both early (laboratory based) and later phase studies of SSc-related RP, and also an ambulatory monitoring tool.REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0436
Date of REC Opinion
13 Jul 2021
REC opinion
Further Information Favourable Opinion