Pedal Pump Clinical Trial on Edema V2
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Hillcrest
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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
Where it's recruiting
Tulsa
Source: ClinicalTrials.gov · NCT07809516 · last updated 2026-09-09