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

May 3, 2012
March 15, 2013
January 2012
May 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01592812 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Arterial Inflow and Muscle Ischemia During Calf Stimulation With the Veinoplus Device
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.

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).

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Artery Disease
Device: electrical muscle stimulation
Duration of the stimulation 20 minutes
Other Name: Veinoplus device
Experimental: electrical stimulation
Evaluation of the effect of calf stimulation on flow and tissue oxygenation
Intervention: Device: electrical muscle stimulation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01592812
2011-A01546-35
Yes
University Hospital, Angers
University Hospital, Angers
Not Provided
Principal Investigator: Pierre Abraham, MD; PhD University Hospital in Angers (France)
University Hospital, Angers
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP