The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- percent of wounds complete closure
研究概览
简要总结
Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area.
Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care
详细描述
Objective
investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area.
Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care Outcomes: the primary outcomes were the wound surface area measurement, % of wound complete closure and % of days needed for surface area reduction before and after receiving the treatment protocol for two consequetive months, and the secondary outcomes were % of wound cause and location frequencies
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)
盲法说明
the patient didn't know the types of modes of laser applied even in the control group i used light not laser to equalize the blindness
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1- Diabetic patients with either type I or II 2- Age from 18-60 years old, both sexes 3- Ulcer lasting longer than two months 4- DFU grade 1 or 2 according to Wagner classification. 5- All patients able to walk dependently
排除标准
- •Patients with vascular disease
- •Patients with fixed ankle deformity as Charcot foot or stiffness
- •Patients with any type of osteomyelitis associated with DFU
- •Patients with renal or hepatic failure
- •BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; altered population of immune mediators may lengthen the inflammatory process & decrease oxygenation of subcutaneous adipose tissue which is liable to be infected.
结局指标
主要结局
percent of wounds complete closure
时间窗: two consecutive months
measure percent of wounds complete closure in each group
percent of wound size measurement methods
时间窗: two consecutive months
weekly by 1. a ruler (wound area was calculated by measuring and multiplying the greatest length by the greatest width perpendicular to the greatest length) 2. a sterile transparent film sheet
次要结局
- percent of each wound location(two consecutive months)
- percent of days needed for surface area reduction(two consecutive months)
- percent of each type of wound cause(two consecutive months)
研究者
Heidy F. Ahmed
Doctor of physical therapy at Al kasr Al Anini teaching hospital, Cairo, Egypt
Cairo University