Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

electrical muscle stimulation

Device
Who is being recruted

Arterial Occlusive Diseases+4

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorUniversity Hospital, Angers
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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).

Official TitleInvestigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.
NCT01592812
Principal SponsorUniversity Hospital, Angers
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesPeripheral Vascular DiseasesAtherosclerosisPeripheral Arterial Disease

Criteria

4 inclusion criteria required to participate
French native

Stable stage 2 peripheral artery disease

Patent femoral artery on both sides

Age > 18 years

2 exclusion criteria prevent from participating
Pregnancy

Adults protected by maw

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Evaluation of the effect of calf stimulation on flow and tissue oxygenation

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University Hospital

Angers, FranceOpen University Hospital in Google Maps
CompletedOne Study Center