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

This study has been completed.
Sponsor:
Information provided by:
University at Buffalo
ClinicalTrials.gov Identifier:
NCT00114608
First received: June 15, 2005
Last updated: March 10, 2008
Last verified: March 2008
  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:


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.

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 26, 2014