Dosing of Electrical Stimulation in Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 主要终点
- Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
研究概览
简要总结
This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic venous insufficiency who have the following are eligible for the study:
- •Able to understand the study and provide meaningful written informed consent for the study.
- •Willing, able, and committed to participate in the procedures for the full length of the study.
- •All ethnic groups, male or female above the age of 18 years.
- •Diagnosis of chronic venous insufficiency (C3-C5 CEAP Classification)
- •Blood pressure currently under moderate control (< 160/100mmHg)
- •No current foot ulceration
排除标准
- •Patients meeting any of the following criteria are to be excluded:
- •Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) that would affect compliance with protocol
- •Has a cardiac pacemaker, AICD or other implanted electrical device
- •Has an Existing DVT.
- •Has recent lower limb injury or lower back pain
- •Has current foot ulceration or other skin ulcers
- •Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
- •Has an ABPI < 0.8
研究组 & 干预措施
Group A
No device utilised for 6 weeks.
Group B
Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.
干预措施: Revitive IX Neuromuscular Stimulation Device (Device)
Group C
Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.
干预措施: Revitive IX Neuromuscular Stimulation Device (Device)
结局指标
主要结局
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
时间窗: 0 and 6 weeks
Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.
次要结局
- Limb Volume(0 and 6 weeks)
- Generic Quality of Life - EQ-VAS(0 and 6 weeks)
- Generic Quality of Life - EQ-5D-5L(0 and 6 weeks)
- Microcirculatory Blood Flow(0 and 6 weeks.)
- Patient Compliance(6 weeks.)
- Venous Flow Parameters - PV(0 and 6 weeks)
- Venous Flow Parameters - VF(0 and 6 weeks)
- Venous Clinical Severity(0 and 6 weeks.)
- Generic Quality of Life - SF-12(0 and 6 weeks)
- Disease Specific Quality of Life(0 weeks and 6 weeks)