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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01592812
First received: May 3, 2012
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Peripheral Artery Disease
Device: electrical muscle stimulation
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • arterial inflow [ Time Frame: during stimulation ] [ Designated as safety issue: No ]
    Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation


Enrollment: 15
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01592812

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

No publications provided by University Hospital, Angers

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01592812     History of Changes
Other Study ID Numbers: 2011-A01546-35
Study First Received: May 3, 2012
Last Updated: March 15, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 19, 2014