Light-based Therapy as a Novel Treatment for Digital Ulcers in Patients With Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety measured by the patient and operator opinion
研究概览
简要总结
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.
详细描述
Study design This is an open pilot study: all participants will receive the light-based treatment (visits 1-6 inclusive). Ten participants with at least one digital ulcer (more than one digital ulcer may be assessed in the study if located on the same hand) will be recruited.
Justification of sample size There are no pilot data to inform a power calculation. Paired measurements on 10 participants gives 90% power to detect a clinically meaningful change in VAS of 2 points at the 5% significance level, provided that the observed standard deviation in paired differences is 1.7 or less. If the observed standard deviation is 2.0, this sample size gives 80% power to detect such a change at the stated significance level.
Methods of data collection
Study visits schedule Participants will attend a total of 8 study visits over two months. Light treatment will be administered twice weekly for three weeks (i.e. the first 6 study visits only). Follow-up visits will be at 1 month (visit 7) and 2 months (visit 8).
Preparation Participants will be asked to abstain from caffeine-containing drinks and from smoking for at least 4 hours prior to study. Sterile gauze and/or water may be used by the investigators (using gloves) to clean the surface of the wound of any debris that could potentially interfere with the light-based treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Unable to give full informed consent.
- •Serious infection of the digital ulcer e.g. osteomyelitis.
研究组 & 干预措施
Custom-built phototherapy lamp
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).
干预措施: Custom-built phototherapy lamp (Device)
结局指标
主要结局
Number of participants with adverse events as a measure of safety measured by the patient and operator opinion
时间窗: Up to three weeks
Number of participants with adverse events as a measure of tolerability measured by the patient opinion
时间窗: Up to three weeks
次要结局
- Digital ulcer severity: participant and operator reported(Up to 8 weeks)
- Laser Doppler imaging (LDI) to measure perfusion to the digital ulcer(Up to 8 weeks)
- High-frequency ultrasound (HFUS) to measure digital ulcer dimensions(Up to 8 weeks)
研究者
Michael Hughes
Arthritis Research UK Clinical Research Fellow
University of Manchester