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Venous Blood Flow Velocity: Electrical Foot Stimulation Compared to Intermittent Pneumatic Compression of the Foot

NCT00114608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-03-11

No results posted yet for this study

Summary

Electrical stimulation of the foot can increase blood flow out of the leg. This increased blood flow can prevent blood clots from forming in the leg veins.

Blood clots in the leg veins can break off and form life-threatening blood clots in the lungs.

Intermittent external pneumatic (air) compression of the foot is already used to increase blood flow in at risk patients.

Hypothesis: Electrical stimulation of the foot increases blood flow out of the legs to the same degree as intermittent external pneumatic (air) compression of the foot.

Conditions

Interventions

DEVICE

The Focus™ Neuromuscular Stimulation System

Electrical foot stimulation was produced by surface electrodes placed on the sole of the foot over the plantar muscle group. Electrical stimulation was delivered by The Focus™ Neuromuscular Stimulation System, Empi, Inc. (St. Paul, MN.) The crucial stimulus parameters were: biphasic symmetrical square wave at 50 pulses per second, phase duration of 300 microseconds, a starting ramp up time of 2 seconds and a finishing ramp down time of 2 seconds per stimulation cycle, and a stimulation cycle of 12 seconds "on" and 48 seconds "off" per minute. Stimulation was increased to an intensity just sufficient to create a slight visible muscle twitch. This level of intensity caused no evident discomfort in any of the subjects in our first study. Subjects were continually monitored throughout this study for any indication of discomfort.The Focus™ Neuromuscular Stimulation System created electrical stimulation of the plantar foot muscles.

Sponsors & Collaborators

  • University at Buffalo

    lead OTHER

Principal Investigators

  • Robert E Kaplan, MD · University at Buffalo School of Medicine and Biomedical Sciences

  • James J Czyrny, MD · University at Buffalo School of Medicine and Biomedical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00114608 on ClinicalTrials.gov