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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, 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:
* 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.)
* Symptomatic peripheral vascular disease
* Wounds or infections in the feet, legs, buttocks, or back
* Weeping lymphedema or bullous cellulitis
* Uncontrolled hypertension (BP\>180/110) in the recent 2 hours
* Uncontrolled hypotension (BP \<80/45) in the recent 2 hours
* Heart rate greater than 110 or less than 45 in the recent 2 hours
* Leg or back surgery in previous 30 days
* Known pregnancy
* Severe osteoporosis/fracture risk
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
No Treatment-Related Adverse Events Scoring 3, 4, or 5 on the CTCAE v4.0 scale