Investigating the cold challenge rewarming period in patients with SSc
Research type
Research Study
Full title
Investigating the rewarming period during the cold challenge protocol in patients with systemic sclerosis.
IRAS ID
282496
Contact name
Ariane Herrick
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Systemic sclerosis (SSc, or ‘scleroderma’) is a multisystem connective tissue disease, with a prevalence of around 250 per million. SSc is associated with major disability and pain and almost all patients with SSc have Raynaud’s phenomenon (RP; episodic colour changes in response to cold or emotional stress) which is the most common presenting feature. In patients with SSc, RP can progress to irreversible tissue damage with ulceration, scarring; and rarely, gangrene and amputation. However, RP is very common, affecting approximately 5% of the population, and is usually 'primary' (no underlying cause). Non-invasive techniques such as thermography can help to differentiate RP secondary to SSc from primary RP, and also to determine severity of RP. Thermography is used clinically to capture the rate of rewarming after hands have been exposed to cold water for one minute, known as the cold challenge test. As standard, the period of image acquisition during the rewarming phase is 15 minutes. However, what we do not know (as patients are not imaged for long enough), is how long it takes for the temperature of the hands to return to their baseline temperature. 20 participants with RP attending Salford Royal Hospital will take part in this study. Participants will undergo a cold challenge test, after which thermal images will continue to be taken until the temperature of the hands returns to what it was at baseline (i.e. before the cold challenge test). Each participant will be in the study for approximately 1.5 hours. Investigating the time taken for hands to rewarm would improve our knowledge of rewarming periods after cold exposure, and could be used to inform studies of treatment response where the cold challenge with thermography is used as an outcome in clinical trials.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/PR/0849
Date of REC Opinion
16 Dec 2020
REC opinion
Favourable Opinion