The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- percent of collagen formation
研究概览
简要总结
Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer 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 conventional wound care treatment
详细描述
Objective
investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer 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 collage formation before and after receiving the treatment protocol for two consequetive months
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 18 and 60 years; both gender; Diabetic patients type II; Ulcer lasting longer than two months; diabetic foot ulcer (DFU) grade 1 (Superficial diabetic ulcer, ulcer limited to the dermis, not extending to the subcutis) or grade 2 (Ulcer of the skin extending through the subcutis with exposed tendon or bone and without osteomyelitis or abscess formation) according to the Wagner classification
排除标准
- •Patients with fixed ankle deformity as Charcot foot or stiffness; Patients with any type of osteomyelitis associated with DFU; the presence of active infection requiring hospitalization, gangrene, systemic diseases such as collagen-vascular diseases, renal failure, evidence of ischemia; BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; an altered population of immune mediators may lengthen the inflammatory process & decrease oxygenation of subcutaneous adipose tissue which is liable to be infected
研究组 & 干预措施
laser sequential mode
All patients received 2 sessions of laser therapy / week with different wavelengths in sequential mode in two consecutive months of treatment aiming complete wound closure , patients received & infrared laser therapy plus traditional wound care
干预措施: laser therapy (Device)
laser seperate mode
All patients received 2 sessions of laser therapy / week with different wavelengths in seperate mode in two consecutive months of treatment aiming complete wound closure , patients received & infrared laser therapy plus traditional wound care
干预措施: laser therapy (Device)
traditional wound care
Traditional wound care inform of
- Wound care treatment
- Debridement to remove necrotic tissue
- Irrigation of the wound by normal saline
- Change dressing daily to protect wound from infection
- Foot care
- Wash feet daily, dry carefully especially between toe
- Avoid extreme temperatures
- Inspection daily of foot blisters
- Foot wear
- Avoid walking bare foot
- Properly fitted shoes
- Avoid wearing open-toed shoes
干预措施: laser therapy (Device)
结局指标
主要结局
percent of collagen formation
时间窗: two consecutive months
by histological pictures
percent of wound size measurement methods
时间窗: two consecutive months
measure percent of wounds decrease surface area
次要结局
- percent of wounds complete closure(two consecutive months)
研究者
Heidy F. Ahmed
Doctor of physical therapy certified wound specialist at Al kasr Al Anini teaching hospital, Cairo, Egypt
Cairo University