Systemic sclerosis (SSc), otherwise referred to as scleroderma Skin and Connective Tissue Diseases
Conditions
Interventions
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 recruitm
Sponsors
Salford Royal NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety will be measured using medical data documenting safety issues at each study visit and between visits (e.g., new concerns about cutaneous changes, pain etc.) at one timepoint 2. Tolerability will be measured using patient-reported pain on a Visual Analog Scale (VAS) (0-100, where 100 is the most severe pain imaginable by the patient) directly attributed to the LLLT will be recorded immediately after treatment, to assess tolerability, at each study visit. 3. Efficacy will be measured using laser Doppler imaging (LDI) immediately before and after the light exposures and then every 10 minutes for 90 minutes 4. Skin temperature which provides an indirect measure of small and large blood vessel function, will be measured using thermography immediately before and after the light exposures, and then every 10 minutes for 90 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of persistent cutaneous digital ischaemia: Taken from the hand original acquired LDI and thermography images (as above), for any digital (finger) ulcers (DU) or pitting scars (DPS) present, perfusion measurements will be assessed at the lesion center (DU/DPS ‘core’) and immediately adjacent tissue (DU/DPS ‘periphery’). Assessment of digital skin fibrosis: The extent/severity of the finger (digital) skin sclerosis on the treated hand shall be assessed: 1. By a trained assessor using the modified Rodnan skin score by manual palpation (0-3 score, where 0 is normal and 3 is severe skin fibrosis/sclerosis). 2. High frequency ultrasound (HFUS) to measures skin thickness of the hands and finger | — |
Countries
England, United Kingdom
Contacts
Public ContactPaul New
Outcome results
None listed