Efficacy of Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Ulcer Healing Rate
研究概览
简要总结
The study evaluates the efficacy of Low-level laser therapy on ulcer healing in patients with diabetic foot ulcer. Half the patients are randomized to receive Low-level laser therapy and a half to recieve the placebo (LED).
详细描述
Low-level laser therapy(LLLT) has been reported to aid ulcer healing in patients with diabetic foot ulcer. However, patients need to come to hospital to receive LLLT performed by medical professional. The LLLT shoe has been developed for home using. Patients can wear LLLT shoe 30 min once daily instead of going hospital for LLT therapy. The aim of this study is to see whether LLLT shoe helps with healing compare with placebo (LED shoe).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic diabetic foot ulcer
- •Ankle brachial index ≥ 0.4
- •Toe pressure brachial index ≥ 0.3
- •Transcutaneous oxygen measurement (TCOM) ≥ 40 mmHg
- •Ulcer size less than 25 cm2
排除标准
- •Infected ulcer
- •HbA1C > 15 %
结局指标
主要结局
Ulcer Healing Rate
时间窗: 12 weeks
Healing rate of control and laser group will be reported at 12 weeks
次要结局
- Time to ulcer healing(time from date of randomisation to date of healing within the 12 month study period)
- Clinical Success - Complications(up to 12 months)