Pedal Pump Device for Leg Swelling in Hospitalized Patients
Tests a pedal pump device for leg swelling in hospitalized adults.
Plain-language title generated from the registry record
Registry title: Pedal Pump Clinical Trial on Edema V1
Key facts
- Where
- Tulsa, United StatesSee the site
Where in United States
- Hillcrest Medical CenterTulsa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- David McVay
- Trial code
- NCT07760363
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
Pedal Pump Clinical Trial on Edema V1
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.
Inclusion: 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); Patients must give informed consent to participate. The patient must be able to read the consent form (in English or Spanish) or give consent after the form is translated for the patient.
Exclusion: Leg or back surgery in previous 30 days; Symptomatic peripheral vascular disease; Wounds or infections in the feet, legs, buttocks, or back; Uncontrolled hypertension (BP>180/110) in the recent 2 hours; Heart rate greater than 110 or less than 45 in the recent 2 hours; Patients using a hospital bed which has the scale on the foot board; Lymphedema (interstitial protein-built fluid); Lipedema (fat distribution); Pressure ulcers; Active DVT (i.e. Patients who have signs of acute unilateral swelling must have a documented negative lower extremity venous duplex ultrasound within the current admission before they will be included in the trial.); Weeping lymphedema or bullous cellulitis; Uncontrolled hypotension (BP <80/45) in the recent 2 hours; Known pregnancy; Severe osteoporosis/fracture risk.