Clinical trial NCT01592812: Arterial Inflow and Muscle Ischemia During Calf Stimulation With the Veinoplus Device
Official title: Investigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Artery Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2012-05-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: arterial inflow
timeFrame: during stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital in Angers (France)
name: Pierre Abraham, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abraham P, Mateus V, Bieuzen F, Ouedraogo N, Cisse F, Leftheriotis G. Calf muscle stimulation with the Veinoplus device results in a significant increase in lower limb inflow without generating limb ischemia or pain in patients with peripheral artery disease. J Vasc Surg. 2013 Mar;57(3):714-9. doi: 10.1016/j.jvs.2012.08.117. Epub 2013 Jan 9.