Light treatment for scleroderma finger ulcers - study 2
Research type
Research Study
Full title
A physiological study to optimise a novel low-level light treatment for digital ischaemia in patients with systemic sclerosis
IRAS ID
351238
Contact name
Michael Hughes
Contact email
Sponsor organisation
Northern Care Alliance NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 7 days
Research summary
Digital (finger) ulcers are common in patients with systemic sclerosis (SSc) otherwise known as scleroderma and many of the current treatments used can cause side effects or are not effective. We want to investigate a novel light-based therapy to potentially treat digital ischaemia (low blood flow) that causes digital ulcers. In our previous study, our custom-built light-based treatment device, consisting of red, infrared, and violet wavelengths was found to be safe and feasible. There were also some early signals of potential benefit for digital ulcers in patients with SSc. To take this treatment approach forward, we now need to refine the optimal ‘dose’ of light.
Participants wishing to take part will need to attend Salford Royal Hospital for three study visits. At the first visit the research team we will examine the participant’s fingers and back of their hands for any skin thickness changes (gently pinching the skin) as is routinely performed in the scleroderma outpatient clinic. Skin thickness will also be measured at these sites using an ultrasound machine
At each visit, participants will receive one of three randomised ‘doses’ of the combination light therapy. The research team wishes to understand how the skin (blood flow and temperature) reacts to increasing dose of light. All patients will receive the three ‘doses’ of light over the three study visits (but not all in the same order), and there is no placebo treatment. The light application to the skin will take approximately 15 minutes to complete.
We will measure the blood flow and temperature of the skin immediately before, directly after, and then every 10 minutes for 90 minutes after the light therapy. These will be measured using a type of scanner called ‘laser Doppler imaging’ and a thermal camera, which will each take approximately 1 minute (or less) per scan.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0044
Date of REC Opinion
6 Mar 2025
REC opinion
Further Information Favourable Opinion