Validation of laser speckle contrast imaging and thermography in SSc
Research type
Research Study
Full title
Validation of laser speckle contrast imaging and thermography in patients with Raynaud's phenomenon secondary to systemic sclerosis.
IRAS ID
169441
Contact name
Andrea Murray
Contact email
Duration of Study in the UK
2 years, 0 months, 0 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, much of which relates to digital vasculopathy, one of the characterising features of SSc. In patients with SSc, Raynaud’s phenomenon (RP, episodic vasospasm which causes pain and colour changes on exposure to cold or emotional stress) can progress to irreversible tissue injury with ulceration, scarring, and sometimes critical ischaemia resulting in gangrene.
Current treatments for RP, especially for SSc-related RP are far from ideal. To date, relatively few high quality clinical trials in SSc-related digital vasculopathy have taken place, in large part due to the paucity of reliable outcome measures. Advances in technology mean that laboratory measurements of blood flow, specifically those obtained using laser Doppler imaging (LDI) and it’s variant, laser speckle contrast imaging (LSCI, direct measure) and thermography (indirect measure) hold promise as outcome measures for SSc-related digital vasculopathy. LDI and thermography are both well established in the research arena and have been used in single-centre studies (primarily cross-sectional) in combination with dynamic challenge/stimulus (e.g. heating or cooling) to induce a change in blood flow and study SSc-related vascular dysfunction.
Limitations to existing studies exploring the reproducibility and validation of LDI, LSCI, and thermography in SSc and RP patients warrant the need for further investigations. Small patient numbers, different patient and control group comparisons, lack of comparable protocol (e.g. the different water temperatures used for cold challenge), and the different parameters extracted from the images make it difficult to compare results.
The aim of this study is to determine the reproducibility and validity of LSCI and thermography, including testing the hypothesis that both methodologies are sufficiently reproducible and valid across centres to allow their use as outcome measures in clinical trials.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0083
Date of REC Opinion
26 Feb 2015
REC opinion
Favourable Opinion