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

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT01592812
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
4
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
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 :
Jan 1, 2012
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

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 Names:
  • Veinoplus device

    		•

    Outcome Measures

    Primary Outcome Measures

    1. arterial inflow [during stimulation]

      Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Angers France

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT01592812
    Other Study ID Numbers:
    • 2011-A01546-35
    First Posted:
    May 7, 2012
    Last Update Posted:
    Mar 18, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Peripheral Arterial Disease

    Study Results

    No Results Posted as of Mar 18, 2013