The Effect of Electrical Stimulation on the Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
研究概览
简要总结
The purpose of this study is to determine whether electrical stimulation is effective in the expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.
详细描述
30 type 2 diabetic patients with ischemic foot ulceration were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=15) or sham ES (placebo, n=15) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Wound fluid sample was collected for VEGF, VEGFR-2, HIF-1α and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) was measured at 1st, 6th, and 12th session.
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)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ischemic diabetic foot ulcer
- •Wagner classification DFU 2
- •0.5<ABI<0.9
- •Mild to moderate diabetic neuropathy
排除标准
- •Fracture in a lower limb
- •A severe infection
- •A malignancy
- •Kidney failure
- •Skin diseases
- •Osteomyelitis
- •Pregnancy
结局指标
主要结局
The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
时间窗: Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
次要结局
- Wound surface area(cm2)(Change from Baseline in wound surface area at 2 and 4 weeks)
研究者
giti torkaman
Professor of physical therapy, Physical therapy department, Faculty of medical sciences, Tarbiat modares univercity
Tarbiat Modarres University