Venous Insufficiency and Neuromuscular Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage Change of Haemodynamic Flow
研究概览
简要总结
The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.
详细描述
STUDY AIMS
- To obtain ultrasound blood flow and velocity measurements in the leg to compare the hemodynamic profiles obtained using a neuromuscular stimulation device with those obtained at rest.
- To ascertain if a 6 week protocol of electrical neurostimulation of the muscle pumps in the leg and foot can reduce clinical symptoms and improve quality of life.
METHODS Controlled interventional trial. Group 1 (10 subjects) will be healthy subjects with no clinical venous disease. Subjects with venous incompetence to be recruited into one of three groups. Group 2 (10 subjects) will have superficial venous incompetence; Group 3 (10 subjects) will have deep venous incompetence; Group 4 (10 subjects) will have deep vein occlusion. These will be clinical diagnoses confirmed with duplex ultrasound.
The device used in this study will be the geko™ T-1 device (Firstkind Ltd, UK). A geko™ device will be fitted to each leg. The device stimulation level is set to the minimum level that can achieve the desired response (outward and upward twitching of the foot when raised from the ground).
ENDPOINTS Primary end-point
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Healthy subjects
Healthy subjects, free from vascular disease
干预措施: geko device (Device)
Superficial venous insufficiency
Clinically symptomatic and ultrasound evidence of superficial venous insufficiency
干预措施: geko device (Device)
Deep venous insufficiency
Clinically symptomatic and ultrasound evidence of deep venous insufficiency
干预措施: geko device (Device)
Deep venous obstruction
Clinically symptomatic and ultrasound evidence of deep venous obstruction
干预措施: geko device (Device)
结局指标
主要结局
Percentage Change of Haemodynamic Flow
时间窗: baseline, 20 minutes
Doppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it.
次要结局
- Improvement in Venous Symptoms(6 weeks)
- Leg Volume(6 weeks)