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

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ClinicalTrials.gov Identifier: NCT00114608
Recruitment Status : Completed
First Posted : June 16, 2005
Last Update Posted : March 11, 2008
Sponsor:
Information provided by:
University at Buffalo

Brief 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.


Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Pulmonary Embolism Device: The Focus™ Neuromuscular Stimulation System Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Venous Blood Flow Velocity: Electrical Foot Stimulation Compared to Intermittent Pneumatic Compression of the Foot
Study Start Date : June 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Electrical foot stimulation
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.



Primary Outcome Measures :
  1. Doppler venous blood flow velocity changes over 4 hours [ Time Frame: Two, 4 hour sessions ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Venous or arterial disease of the lower limbs
  • Cardiac pacemaker
  • Known allergy to materials of surface electrodes
  • Neurologic disorder
  • Lower extremity fracture history
  • History of joint replacement surgery
  • Anticoagulation therapy other than aspirin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114608


Locations
United States, New York
Erie County Medical Center
Buffalo, New York, United States, 14215
Sponsors and Collaborators
University at Buffalo
Investigators
Principal Investigator: Robert E Kaplan, MD University at Buffalo School of Medicine and Biomedical Sciences
Principal Investigator: James J Czyrny, MD University at Buffalo School of Medicine and Biomedical Sciences

Publications:
Responsible Party: Robert E. Kaplan, MD, Associate Clinical Professor, University at Buffalo School of Medicine and Biomedical Sciences
ClinicalTrials.gov Identifier: NCT00114608     History of Changes
Other Study ID Numbers: STUDY # 2
First Posted: June 16, 2005    Key Record Dates
Last Update Posted: March 11, 2008
Last Verified: March 2008

Keywords provided by University at Buffalo:
Electrical foot stimulation
Intermittent pneumatic compression
Venous thromboembolism
Immobilization
Total hip replacement
Prolonged travel
Venous thromboembolic disease (VTE)
Deep vein thrombosis (DVT)
Pulmonary embolism (PE)

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases