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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Doppler venous blood flow velocity changes over 4 hours [ Time Frame: Two, 4 hour sessions ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114608
|United States, New York|
|Erie County Medical Center|
|Buffalo, New York, United States, 14215|
|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|