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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01592812
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : March 18, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: electrical muscle stimulation Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. arterial inflow [ Time Frame: during stimulation ]
    Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01592812

University Hospital
Angers, France
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Pierre Abraham, MD; PhD University Hospital in Angers (France)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Angers Identifier: NCT01592812     History of Changes
Other Study ID Numbers: 2011-A01546-35
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases