Investigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- arterial inflow
研究概览
简要总结
Stimulation of arterial inflow to the lower limb is important to obtain functional improvement in peripheral artery diseased (PAD) patients with claudication. The clinical effect of muscle stimulation to increase arterial inflow and the direct evaluation of the regional blood flow impairment (RBFI) in the area of stimulation, have not been evaluated in PAD patients.
Fifteen adult patients with stable arterial claudication will participate. Recruitment will be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope) After two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an increasing frequency rate with 5 min steps (1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz) on the most symptomatic side.
The investigators record the tcpo2 value, arterial blood inflow with ultrasound of the femoral artery, and near infra-red spectrometry (NIRS) on both sides.
Patients will be instructed to report eventual contraction-induced pain in the stimulated calf.
详细描述
Investigations are conducted in an air-conditioned 22+/-2 °C room, with the patient comfortably seated on an armchair.
Measured ware started at rest and performed throughout the period pf stimulation and for 10 minutes after the end of the stimulation
Muscle stimulation:
We apply a series of 20 minutes of stimulation with the Veinoplus® device. The device delivers a stimulation of incremental rate with 5 minutes intervals, with 1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz and then stops automatically.
Ultrasound measurements The Diameter of the superficial femoral artery was measured at rest on both sides before each study. The VTI of 3 cardiac cycles (three peaks systolic velocity) will be measured by duplex ultrasound imaging, to calculate the arterial inflow to the leg. Results will be expressed in l /min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •French native
- •Stable stage 2 peripheral artery disease
- •Patent femoral artery on both sides
- •Age > 18 years
排除标准
- •Pregnancy
- •Adults protected by maw
结局指标
主要结局
arterial inflow
时间窗: during stimulation
Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation
次要结局
未报告次要终点