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OpenTrials
Completed

NCT Number: NCT01939288

Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics

What is known?

* Disorders of peripheral circulation result in vascular morbidity and mortality * Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease * The benefit of intermittent pneumatic compression is clinically well evidenced. * The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source.

What new information will this trial contribute?

- This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation

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Key information

Conditions

Intermittent Pneumatic Compression

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Vascular Surgery, Charing Cross Hospital

London, W6 8RF, United Kingdom

About this study

RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease.

OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects.

METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >18 yrs, Body Mass Index (BMI) 17-30Kg/m2

Exclusion criteria

History of heart disease or respiratory disorder, pregnancy, history of peripheral vascular disease or previous thromboembolic event, ABPI< 0.9, cardiac pacemaker, history of leg fractures and/or presence of metal implants in the leg, long distance travel within one week prior to study

Treatment and study plan

Neuromuscular stimulation, followed by intermittent pneumatic compression

Device

Other names: Device 1 followed by a break, followed by device 2

Intermittent pneumatic compression, followed by neuromuscular stimulation

Device

Other names: Device 2, followed by a short break then device 2

Primary outcomes

  1. IPC(on) Peak Velocity Change From Baseline

    Time frame: One day

    Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery

Other outcomes

  1. NMES(on) Peak Velocity Change From Baseline

    Time frame: One day

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2013
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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