Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- rate of bone healing
研究概览
简要总结
thirty-four patients with charcot foot ulcer will be included, their ages will be ranged from 50 to 70 years old and randomly distributed into two equal groups : study group includes 17 patients who will recieve pulsed electromagnetic field and electrical stimulation three days per week for three months .
control group includes 17 patients who will recieve electrical stimulation , standard wound care and medical treatment
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ranges between 50 and 70 years old male and female patients all patients with charcot foot ulcer
排除标准
- •presence of malignancy hypotensive patients pregnancy immunological and rheumatological disorders
研究组 & 干预措施
Group A (Study group)
PEMF group who recieves pulsed electromagnetic field therapy and electrical stimulation
干预措施: pulsed electromagnetic field therapy (Device)
Group A (Study group)
PEMF group who recieves pulsed electromagnetic field therapy and electrical stimulation
干预措施: Transcutanous electrical nerve stimulation (Device)
Group B(control group)
who recieves standard wound care , electrical stimulation and medical treatment
干预措施: Transcutanous electrical nerve stimulation (Device)
Group B(control group)
who recieves standard wound care , electrical stimulation and medical treatment
干预措施: Vancomycin (Drug)
结局指标
主要结局
rate of bone healing
时间窗: Baseline and three months
asses rate of bone healing through plain x-ray after six weeks then after twelve weeks from initiation of treatment
次要结局
- ulcrer healing(baseline and three months)
研究者
Norhan Mohamed Eltayeb
Bachelor's degree, MSc candidate
Cairo University