Effect of Magnetic Current on Chronic Ulcer Healing of Diabetic Foot
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ulcer size
研究概览
简要总结
This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group):
1- Group A: Pulsed electromagnetic field (PEMF) group. 2- Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up.
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详细描述
This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group):
- Group A: Pulsed electromagnetic field (PEMF) group.
- Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up.
Outcome measures will include:
- Wound closure.
- Wound depth.
- Microcirculation.
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The ankle brachial index should fall between 0.9 and 1.2 to reassure that arterial insufficiency was not causing or contributing to the nonhealing wound.
- •Patients diagnosed with diabetes with unsatisfactory healing of ulcer(s) in the preceding 4 weeks.
- •Wagner grade 1 or 2 ulcers on the foot without exposure of bone, muscle, ligaments, or tendons.
排除标准
- •1- Ulcers secondary to non-diabetic etiology. 2- Poorly controlled diabetes. 3- Pregnancy. 4- Patients wearing a pacemaker or with malignancy or history of radiotherapy. 5- Patients who were taking medications that might affect their circulation or sensation and motor functioning and patients with any history of alcoholism were also excluded.
- •6- Patients who had clinical signs of infection or were taking antibiotics at the time of enrollment.
研究组 & 干预措施
group A
Pulsed electromagnetic therapy will be delivered at the frequency of 12Hz, with magnetic flux density of 12G. Each treatment session will last for 1 hour, which will be repeated for 14 sessions within 3weeks. 20 patients will remain in the study until the wound heals or 14 sessions will be completed, whichever came first
干预措施: pulsed electromagnetic currant machine (Device)
Group B
20 patients will receive intervention by using the same PEMF unit, but the output will be shut off.
干预措施: Placebo (Other)
结局指标
主要结局
ulcer size
时间窗: 4 weeks
smart phone applications used to calculate wound size
Doppler ultrasonography
时间窗: 4 weeks
used to calculate wound depth and microcirculation angiogenesis
次要结局
未报告次要终点
研究者
Mahmoud Awad Ramadan Elkholy
lecturer of physical therapy for integumentary system disorders
Beni-Suef University