Efficacy of High-Intensity Laser Therapy in the Management of Venous Leg Ulcers: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Percent change in ulcer area from baseline to end of treatment
研究概览
简要总结
This randomized controlled trial will evaluate the effects of high-intensity laser therapy on wound healing in patients with venous leg ulcers. Participants will be randomly assigned to receive either laser therapy plus standard care or standard care alone. The laser therapy will be administered 3 times per week for 8 weeks or until ulcer closure. The primary outcome is proportion of participants with complete ulcer closure.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 years up to 65 years.
- •Presence of a venous leg ulcer, confirmed by clinical examination and Doppler ultrasound (venous reflux > 0.5 seconds).
- •Ulcer size between 1 cm² and 20 cm² at screening.
- •Ulcer duration of at least 4 weeks but not more than 12 months.
- •Ankle-brachial index (ABI) ≥ 0.8, assessed by Doppler ultrasound.
- •Willing and able to provide informed consent and comply with study procedures.
排除标准
- •Presence of an active infection in the ulcer, confirmed by clinical signs and positive culture results.
- •Osteomyelitis, diagnosed by radiographs or magnetic resonance imaging (MRI).
- •Patients with a history of uncontrolled diabetes, defined as HbA1c level > 10%.
- •Current or planned use of systemic immunosuppressive drugs or corticosteroids during the study period.
- •Pregnant or breastfeeding women.
- •Patients with a history of malignancy or photosensitive skin disorders.
- •Prior history of skin grafting or flap surgery in the affected area within the past 3 months.
结局指标
主要结局
Percent change in ulcer area from baseline to end of treatment
时间窗: Baseline, 4 weeks, 8 weeks and 12 weeks after randomization
Ulcer area will be measured by tracing the wound perimeter on acetate paper and entering into image analysis software to calculate area in cm2. Percent change in ulcer area will be calculated as (area at end of treatment - area at baseline) / area at baseline x 100.
次要结局
- Time to complete ulcer closure(From baseline (week 0) until complete closure, up to 12 weeks.)
- Incidence of treatment-related adverse events(From initial treatment until 4 weeks after final treatment, up to 12 weeks total.)
- Changes in Quality of life(Change in total score on the Cardiff Wound Impact Schedule will be assessed from baseline (week 0), 4 weeks, 8 weeks and 12 weeks after randomization)
- Rate of complete ulcer closure at end of treatment(Single time point at end of study at 12 weeks)
研究者
Mohamed Magdy ElMeligie
Director of Electromyography lab
Ahram Canadian University