Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- wound surface area
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of extravascular Low-level laser therapy (LLLT) versus offloading exercises on foot ulcers healing (DFUs) in type 2 diabetic patients. could include sixty patients with type 2 diabetes associated with diabetic foot ulcer as a complication, their ages ranging from 45 - 55 years. Patients will be selected from Faculty of Medicine (Kasr Al-Aini) Cairo University. They will be referred by the physician after a complete medical evaluation. . The main question it aims to answer is there any significant difference between extravascular low-level laser therapy and offloading exercise on diabetic foot ulcer healing in type 2 diabetic patients ?
After clinical assessment patients will be randomly allocated into three groups equal in number:
Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch device) combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).
Group (B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).
Group (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usual wound care only for 12 weeks (3 sessions/ week).
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
- None
入排标准
- 年龄范围
- 45 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index of 25-34.9 kg/m
- •Glycated hemoglobin (HbA1c) >7 %.
- •ABP index absolute normal (1-1.3)
- •Patient with polyneuropathy.
- •Patient suffer from diabetes more than 5 years.
- •Patient has chronic unhealed diabetic ulcer from 4 weeks up to 6 weeks.
排除标准
- •Patients with history of hypo- hyperglycemic coma.
- •Uncontrolled cardiovascular complications.
- •Malignancy, Anemia, Hemorrhagic diseases.
- •Cardiac peace maker.
- •Deep venous thrombosis.
- •Osteomyelitis.
- •Patients with Monckeberg sclerosis.
- •Photosensitivity to laser.
研究组 & 干预措施
B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with
干预措施: Buerger Allen exercise (Other)
(C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usua
干预措施: Regular wound care (Other)
结局指标
主要结局
wound surface area
时间窗: From enrollment to the end of treatment at 2 weeks
Glycated hemoglobin HbA1c
时间窗: From enrollment to the end of treatment at 12weeks
次要结局
未报告次要终点
研究者
Heba afifi
lecturer Assistant
Cairo University
