Light Treatment for Scleroderma Finger Ulcers

NCT02472743 | Completed

• 1 other identifier: 2014/196DERM
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Digital (finger) ulcers are common in patients with systemic sclerosis (SSc) and causes much pain and affects how patients use their hands. Our current treatments for digital ulcers are often not effective and have may have significant side effects (because they increase blood flow to the ulcer to try and help healing). Light-based treatment has been successfully used to treat chronic diabetic, pressure and venous ulcers. The investigators wish to investigate whether light-based treatment is a safe and effective treatment for digital ulcers in patients with SSc.

Conditions

Scleroderma, Systemic; Ulcer

Keywords

Phototherapy

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events as a measure of safety measured by the patient and operator opinion

  Up to three weeks

• Number of participants with adverse events as a measure of tolerability measured by the patient opinion

  Up to three weeks

Secondary Outcomes (3)

• Digital ulcer severity: participant and operator reported

  Up to 8 weeks

• High-frequency ultrasound (HFUS) to measure digital ulcer dimensions

  Up to 8 weeks

• Laser Doppler imaging (LDI) to measure perfusion to the digital ulcer

  Up to 8 weeks

Study Arms (1)

Custom-built phototherapy lamp

EXPERIMENTAL

Custom-built phototherapy lamp: All participants will receive light treatment twice weekly for three weeks (or until ulcer/s healing) to one or both hands (both hands if ulcer/s present bilaterally). The participant will place their hand within the treatment area of the light-based device (total treatment area approximately 15cm2), aiming to centralise the digital ulcer/s to the centre of the treatment region. At each treatment study visit (visits 1-6 inclusive), the device will undergo a period of (automatic) calibration before use. All three wavelengths (red, infrared and blue) will be delivered simultaneously in combination, with the fluence of the device set at \[3J/cm2\] (treatment duration approximately 10 to 15 minutes).

Device: Custom-built phototherapy lamp

Interventions

Custom-built phototherapy lamp DEVICE

Described in the arm description

Also known as: N/A: Custom built in house

Custom-built phototherapy lamp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a confirmed diagnosis of SSc.
• Eighteen years of age or older at the time of recruitment.
• Able to give full informed consent.
• An active digital ulcer on any aspect of the finger/s (e.g. digital-tip or extensor)

You may not qualify if:

• Unable to give full informed consent.
• Serious infection of the digital ulcer e.g. osteomyelitis.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Salford Royal NHS Foundation Trust

Manchester, Manchester, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Ulcer

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Hughes, MSc MRCP

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arthritis Research UK Clinical Research Fellow

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: June 16, 2015
• Study Start: December 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

GB (1)