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

March 15, 2013 updated by: University Hospital, Angers

Investigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial inflow
Time Frame: during stimulation
Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation
during stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (ESTIMATE)

May 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A01546-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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