REVITIVE for the Treatment of Patients With Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
研究概览
简要总结
To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.
详细描述
This is a pilot randomised control trial to assess the efficacy of a neuromuscular electrical stimulation device to improve venous blood flow and patients' symptoms in patients with chronic venous insufficiency. The Revitive IX device is a neuromuscular electrical stimulation device that gives wide pulse pattern electrical stimulation via foot pads. A cycle of treatment consists of a 30 minute programme of 15 varying waveforms that last a minute each.
Twenty patients with venous insufficiency will be screened according the eligibility criteria. Patients will be randomised to either treatment or control (sham device) group. Patients are advised to use the device 30 minutes a day, everyday, for 6 weeks. Compliance will be monitored with a data logger and diary card.
Primary outcome measure:
a) improvement in venous haemodynamics.
Secondary outcome measures:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability 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 (C2-C5 CEAP classified)
- •Be of non-childbearing potential; or using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the device.
- •Blood pressure currently under moderate control (<160/100mmHg)
- •No current foot ulceration.
排除标准
- •Has insufficient ability to understand the subject information sheet, consent form and verbal instruction.
- •Has an unstable condition (eg psychiatric disorder, a recent history of substance abuse or otherwise thought to be unreliable or incapable of complying wight he requirements of the clinical investigational plan (CIP).
- •Has any metal implants.
- •Pregnant.
- •Has a cardiac pacemaker, AICD or other implanted electrical device.
- •Has an existing DVT.
- •Has an acute medical condition other than chronic venous insufficiency.
- •Has recent lower limb injury or lower back pain.
- •Has current foot ulceration or other skin ulcers.
- •Has cardiovascular disease.
- •Has foot deformities.
- •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
REVITIVE IX: sham device
Trial participants will receive a sham device
干预措施: REVITIVE IX (Device)
REVITIVE IX: actual device
Trial participants will receive the true Revitive IX device
干预措施: REVITIVE IX (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
Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity
次要结局
- Changes in Limb Swelling, Volume(0 and 6 weeks)
- Clinical Symptoms(0 and 6 weeks)