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Pedal Pump Clinical Trial on Edema V2

Sponsor: Hillcrest • ClinicalTrials.gov ID: NCT07809516

Registry updated: 2026-09-09

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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. 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, almost the same as Pedal Pump Clinical Trial on Edema V1 that is underway; however, this study focuses primarily on the objective data gathered by trained Occupational Therapists who regularly measure lower extremities. Key Question for this second 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.

Interventions

Pedal Pump (Device)
The Pedal Pump device pumps both feet for 10 minutes continuously-- mobilizing their whole body in sufficient manner to see the nose move.
Pedal Pump Sham (Device)
The Sham Intervention is the same as Pedal Pump Intervention with the exact same Pedal Pump device generating identical operational sounds and visible movement; however, the patient's body will not be close enough to the device to produce sufficient displacement to transmit mechanical forces beyond the feet. The Pedal Pump will only contact the heel protector pillows enough to make the toes move but will not contact them enough to mobilize the legs or the entire body.

Eligibility criteria

Inclusion Criteria: * Bilateral lower extremity edema of at least mild severity judged by the treating clinician to be due to CHF, chronic venous insufficiency, kidney disease, lymphedema, 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 Criteria: * Lipedema (fat distribution) as the only cause for edema * 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.) * Symptomatic peripheral vascular disease * Wounds or infections in the feet, legs, buttocks, or back deemed unfit for treatment per the trained Operator. * Leg or back surgery in previous 30 days * Known pregnancy * Severe osteoporosis/fracture risk

Conditions

Lower Extremity Edema Lower Extremity Edema Chronic CHF - Congestive Heart Failure CHF Exacerbation Chronic Venous Insufficiency, CVI

Locations

Hillcrest Medical Center — Tulsa, Oklahoma, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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