Ultrasound& Capillaroscopy to measure scleroderma finger ulcers
Research type
Research Study
Full title
Imaging digital ulcer status in patients with systemic sclerosis: High frequency ultrasound and peri-ulcer capillaroscopy
IRAS ID
155874
Contact name
Michael Hughes
Contact email
Sponsor organisation
The University of Manchester
Research summary
Digital (finger) ulcers are common in patients with systemic sclerosis (SSc) and account for much of the pain and disability associated with the disease. Currently, response to intervention (e.g. healing) of ulcers in clinical trials (including of novel therapeutics) is based upon clinician visual assessment. Such an outcome measure is however subjective, and may be insensitive to small, though clinically meaningful change e.g. reduction in size of the ulcer by half.
The development of reproducible, objective methods of measurement is therefore required for use in clinical studies of SSc-related digital ulceration.
One possible measure could be high-frequency ultrasound (HFUS) which is currently used as a research tool to measure skin thickness in patients with SSc. We plan to measure the surface and base dimensions (the length & width) of the ulcer. In addition, new computer software has been engineered to calculate digital ulcer volume. If HFUS is shown to reliably measure the size and/ or volume of digital ulcers, then HFUS could potentially be applied in future studies of treatment response in SSc-related digital ulcers.
Another measure could be to perform capillaroscopy around the digital ulcer. Capillaroscopy is a non-invasive, ‘window’ into the (micro)circulation. Nailfold capillary abnormalities in patients with SSc (e.g. dilated capillaries and areas of haemorrhages) have been well-described and may allow the prediction of future digital ulcers. New blood vessel growth is a key part of natural skin healing, therefore, the identification and description of the capillaries around digital ulcers may represent another way to measure digital ulcer status.
REC name
North West - Preston Research Ethics Committee
REC reference
14/NW/1125
Date of REC Opinion
31 Jul 2014
REC opinion
Favourable Opinion