Arterial Inflow and Muscle Ischemia During Calf Stimulation With the Veinoplus Device
|ClinicalTrials.gov Identifier: NCT01592812|
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : March 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease||Device: electrical muscle stimulation||Phase 4|
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
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.
Tcpo2 recording TcpO2 is measured at the chest and on both calves with TCM 400 (Radiometer, DK). Results are expressed in DROP index(mmHg) values.
Near Infra-red spectroscopy (NIRS) We use the ARTinis NIRS device (ARTinis; NL) to estimate tissue saturation (StO2) on both gastrocnemius muscles of the leg.
Systemic hemodynamic parameters
Systemic and diastolic arterial pressures and heart rate are recorded every two minutes using Dinamap V100 (GE france).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.|
|Study Start Date :||January 2012|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
Experimental: electrical stimulation
Evaluation of the effect of calf stimulation on flow and tissue oxygenation
Device: electrical muscle stimulation
Duration of the stimulation 20 minutes
Other Name: Veinoplus device
- arterial inflow [ Time Frame: during stimulation ]Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592812
|Principal Investigator:||Pierre Abraham, MD; PhD||University Hospital in Angers (France)|