Arterial Inflow and Muscle Ischemia During Calf Stimulation With the Veinoplus Device

Phase 4

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: electrical muscle stimulation

• Registration Number: NCT01592812
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

Detailed Description

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.

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-07
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-15
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• French native
• Stable stage 2 peripheral artery disease
• Patent femoral artery on both sides
• Age > 18 years

Exclusion Criteria

• Pregnancy
• Adults protected by maw

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
electrical stimulation	electrical muscle stimulation	Evaluation of the effect of calf stimulation on flow and tissue oxygenation

Primary Outcome Measures

Name	Time	Method
arterial inflow	during stimulation	Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France