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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01592812
Enrollment
15
Registered
2012-05-07
Start date
2012-01-31
Completion date
2012-05-31
Last updated
2013-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

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.

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).

Interventions

Duration of the stimulation 20 minutes

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
arterial inflowduring stimulationUltrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026