How do skin blood flow, oxygenation and colour compare in RP
Research type
Research Study
Full title
Pilot study to determine the relationship between skin perfusion, oxygenation and skin colour in patients with Raynaud’s phenomenon (RP) secondary to systemic sclerosis as a pathway to an ambulatory monitoring tool for clinical trials.
IRAS ID
247925
Contact name
Lynne MacRae
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
1 years, 0 months, days
Research summary
Patients with Raynaud’s phenomenon (RP) experience episodic colour changes of the skin in response to cold or stress. Primary (i.e., no underlying cause) Raynaud’s occurs in approximately 5% of an otherwise healthy population. Less commonly, Raynaud’s can be secondary to an underlying condition such as systemic sclerosis (SSc); a multisystem connective tissue disease causing ischaemia (lack of blood flow), hypoxia (impaired oxygenation) and fibrosis (thickening) of skin and internal organs. Current treatments are far from ideal. One reason for the lack of treatments is that it is difficult to measure RP attacks (and their severity), and it is therefore difficult to prove whether new proposed treatments are effective.
Improved treatments are needed for both primary and secondary Raynaud’s phenomenon. Clinical trials can be difficult as testing of drugs typically involves inducing an attack in a laboratory. However, ambulatory monitoring would allow testing of new drugs in the patients’ home environment where they usually experience attacks, thus allowing a much more realistic assessment of efficacy. Mobile phone technology advancements mean that ambulatory monitoring of, and capture of biomarkers from patients is now possible and could facilitate clinical trials.
This study aims to establish whether mobile phone monitoring (of temperature, blood flow and changes in skin colour) could inform future clinical trials. Thirty patients with systemic sclerosis (SSc) and 30 healthy controls will be recruited into this study to attend for a single visit at Salford Royal hospital. Participants will undergo imaging of their hands with and without a pressure cuff on their finger, using a thermal mobile phone camera, a second mobile phone camera and multispectral imaging which looks at oxygenation in the skin. The data extracted from the images will be used to inform monitoring of RP in future clinical trials.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1630
Date of REC Opinion
1 Oct 2018
REC opinion
Further Information Favourable Opinion