Arterial Inflow and Muscle Ischemia During Calf Stimulation With the Veinoplus Device
NCT ID: NCT01592812
Last Updated: 2013-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
15 participants
INTERVENTIONAL
2012-01-31
2012-05-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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electrical stimulation
Evaluation of the effect of calf stimulation on flow and tissue oxygenation
electrical muscle stimulation
Duration of the stimulation 20 minutes
Interventions
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electrical muscle stimulation
Duration of the stimulation 20 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable stage 2 peripheral artery disease
* Patent femoral artery on both sides
* Age \> 18 years
Exclusion Criteria
* Adults protected by maw
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Pierre Abraham, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital in Angers (France)
Locations
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University Hospital
Angers, , France
Countries
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References
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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.
Other Identifiers
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2011-A01546-35
Identifier Type: -
Identifier Source: org_study_id
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