NCT00114608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

March 11, 2008

Status Verified

March 1, 2008

Enrollment Period

2.1 years

First QC Date

June 15, 2005

Last Update Submit

March 10, 2008

Conditions

Deep Vein ThrombosisPulmonary Embolism

Keywords

Electrical foot stimulationIntermittent pneumatic compressionVenous thromboembolismImmobilizationTotal hip replacementProlonged travelVenous thromboembolic disease (VTE)Deep vein thrombosis (DVT)Pulmonary embolism (PE)

Outcome Measures

Primary Outcomes (1)

  • Doppler venous blood flow velocity changes over 4 hours

    Two, 4 hour sessions

Study Arms (1)

1

EXPERIMENTAL

Electrical foot stimulation

Device: The Focus™ Neuromuscular Stimulation System

Interventions

The Focus™ Neuromuscular Stimulation SystemDEVICE

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.

1

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Related Publications (1)

  • 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.

    PMID: 12195689BACKGROUND

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismVenous Thromboembolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismThromboembolism

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2005

First Posted

June 16, 2005

Study Start

June 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

March 11, 2008

Record last verified: 2008-03

Locations

US(1)