Pedal Pump Clinical Trial on Edema V1

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid McVay

About this trial

Previous research on the osteopathic manual technique entitled "Pedal Pump" has shown health benefits, specifically increasing lymphatic flow, decreasing lower extremity edema, and decreasing serum lactic acid after maximal exercise. However, due to the limitation of human practitioners, research has been limited.

The Pedal Pump is now a device which facilitates consistency in treatment and allows for increased sample size in research. This clinical trial studies the effects of 10 minutes of Pedal Pump treatment for hospitalized patients with lower extremity edema.

Key Question for this first study: Is the Pedal Pump a feasible treatment for hospitalized patients? Secondary question: Does the Pedal Pump decrease lower extremity edema?

This is a novel idea in its early stage of development, so Investigators anticipate product advancements, further testing with larger population sizes, and future publications.

Eligibility criteria

Qualifiers

Bilateral lower extremity edema of at least mild severity judged by the treating clinician to be due to CHF, chronic venous insufficiency, kidney disease, or other etiologies of fluid overload conditions.

Medically stable

Able to remain in Fowler position for 10 minutes

Patients in the ER, observation, or admitted to the hospital for any period of time; outpatients (specifically CHF clinic patients)

Disqualifiers

Patients using a hospital bed which has the scale on the foot board

Lymphedema (interstitial protein-built fluid)

Lipedema (fat distribution)

Pressure ulcers

Trial design

Treatments tested in this trial

  • Pedal Pump
  • Pedal Pump Sham

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

David McVay

Lead sponsor

Hillcrest

Sponsor institution