Venous Blood Flow Velocity: Electrical Foot Stimulation Compared to Intermittent Pneumatic Compression of the Foot - Full Text View

Purpose

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	Intervention	Phase
Deep Vein Thrombosis Pulmonary Embolism	Device: The Focus™ Neuromuscular Stimulation System	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Venous Blood Flow Velocity: Electrical Foot Stimulation Compared to Intermittent Pneumatic Compression of the Foot

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Foot Health Pulmonary Embolism

U.S. FDA Resources

Further study details as provided by University at Buffalo:

Primary Outcome Measures:

Doppler venous blood flow velocity changes over 4 hours [ Time Frame: Two, 4 hour sessions ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	June 2005
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

Kaplan RE, Czyrny JJ, Fung TS, Unsworth JD, Hirsh J. Electrical foot stimulation and implications for the prevention of venous thromboembolic disease. Thromb Haemost. 2002 Aug;88(2):200-4.

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
Study First Received:	June 15, 2005
Last Updated:	March 10, 2008
Health Authority:	United States: Institutional Review Board

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:

Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013