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Clinical Trials/NCT00114608
NCT00114608CompletedPhase 1

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

University at Buffalo1 site in 1 country40 target enrollmentStarted: June 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Doppler venous blood flow velocity changes over 4 hours

Study Overview

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.

Detailed Description

ABSTRACT Background: Venous stasis caused by immobility is an important risk factor for venous thromboembolic disease. This is especially true for orthopedic patients with multiple trauma and those undergoing other orthopedic procedures. A safe and convenient method for reducing venous stasis would be useful for preventing venous thrombosis in patients while in hospital and particularly after discharge during rehabilitation. In a prior study, we demonstrated that electrical stimulation of the foot was a safe and convenient method for counteracting venous stasis. In this study, we compare the effects on venous blood flow of intermittent pneumatic compression, an established method, to electrical stimulation of the foot.

Methods: 40 healthy volunteers aged 50 - 80 were seated for 4 hours during which they received mild electrical stimulation of the sole of the foot (plantar plexus of muscles) or intermittent pneumatic compression. Popliteal and femoral venous blood flow velocities were measured via Doppler ultrasound. Blood flow in the non-stimulated or non-compressed lower extremity served as a simultaneous control. Subjects completed a questionnaire regarding their acceptance and tolerance of both treatments.

INTRODUCTION Venous thrombosis and pulmonary embolism or venous thromboembolism (VTE) are important complications of medical and surgical conditions that are associated with prolonged immobilization. This is especially true for orthopedic patients with multiple trauma and those undergoing other orthopedic procedures. Immobilization is also a major contributor to the increased risk of VTE associated with prolonged air travel.

Despite good evidence that prophylaxis is effective, there is widespread under utilization of prophylaxis for VTE following major surgical procedures as well as medical conditions that produce weakness or prolonged bed rest. There is also good evidence that the risk of VTE continues for weeks after major orthopedic as well as other types of surgery. It is now recognized that VTE occurring in the hospital and outside the hospital setting is a single entity and that extended prophylaxis with anticoagulants reduces the risk.

Anticoagulant prophylaxis after hospital discharge although indicated in certain high risk groups is inconvenient since the recommended methods, LMWH and fondaparinux must be administered by subcutaneous injection and warfarin requires laboratory monitoring.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

1

Experimental

Electrical foot stimulation

Intervention: The Focus™ Neuromuscular Stimulation System (Device)

Outcomes

Primary Outcomes

Doppler venous blood flow velocity changes over 4 hours

Time Frame: Two, 4 hour sessions

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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