The Effect of Low-intensity Direct Current on the Expression of Vascular Endothelial Growth Factor and Nitric Oxide in Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The plasma level of VEGF(pg/ml) and NO (microM)
研究概览
简要总结
This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration.
详细描述
Twenty type 2 diabetic patients with foot ulceration and 13 age-matched healthy subjects were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=10) or sham ES (placebo, n=10) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Blood sample was collected for VEGF and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) and skin temperature were 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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Wagner classification DFU 2;
- •age 40-60 years;
- •mild to moderate diabetic neuropathy;
- •wound surface area>1.5cm2
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 plasma level of VEGF(pg/ml) and NO (microM)
时间窗: prior to the 1st electrical stimulation session(day 1) and 1 hour later, and prior to the 12th electrical stimulation session(day 26) and 1 hour later
次要结局
- Wound surface area(cm2)(on day 1, 12, and 26)
- skin temperature (degree of centigrade)(prior the 12th electrical stimulation session (day 26) and 1 hour later)
研究者
giti torkaman
professor
Tarbiat Modarres University