A physiological study to optimise a novel low-level light treatment for digital ischaemia in patients with systemic sclerosis
Systemic sclerosis (SSc), otherwise referred to as scleroderma
This is a clinical trial to study a novel intervention that will investigate the effectiveness and safety of Low Level Light Therapy (LLLT) in patients with systemic sclerosis (SSc). Patient recruitment: Twenty patients > 18 years of age with SSc-spectrum disorders will be recruited from Salford Royal Hospital. Study visits protocol: Prior to the initial study visit, an independent member of the study team shall perform the randomisation procedure. Randomisation will be done in-house by the study team (using a random number generator/Excel, etc). All patients shall receive combined sequential red (810nm)/infrared (850nm) followed by blue (410nm) wavelengths. The dose per visit shall be dose-escalated in a pre-determined randomised order over the course of the three study visits: 5 J/cm², 10 J/cm², and 20 J/cm². Participants will be randomised before their first study visit by a member of the research team using an excel random number generator to complete the task. Study visits will be conducted in a temperature-controlled (at 23°C) laboratory at Salford Royal Hospital. Patients will attend a total of 3 study (morning) visits over 3 (ideally consecutive) days. The minimum time between study visits is 1 day, and the maximum time between study visits shall be 3 days. Relevant patient- and disease-related demographics and characteristics shall be collected. At each study visit, any relevant change/s to the current drug treatment will be documented. Preparation: Patients will be asked to abstain from caffeine-containing drinks and smoking for at least 4 hours prior to the study. Application of the LLLT device: We will apply the LLLT (for all study visits) to the dominant hand unless there are specific reasons not to. Both the patient and device operator/s will wear appropriate safety goggles at all times whilst the LLLT device is in operation. The patient will place their hand within the treatment area of the light-based device. The device will be directly cont
1. Clinician confirmed diagnosis of SSc-spectrum disorder. 2. Eighteen years of age or older at the time of recruitment 3. Able to give full informed consent 4. Steady dose (for at least 2 weeks) of relevant prescribed drug (e.g., vasodilatory and vasoactive) therapies for SSc-associated vasculopathy
1. Patients receiving treatment with intravenous vasodilatory/vasoactive therapy (e.g., iloprost) 2. Finger digital ulcers currently requiring hospital admission (e.g., to receive iloprost) or awaiting surgery for digital vasculopathy 3. Currently receiving phototherapy for clinical reasons (e.g. ultraviolet-B therapy)