No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
David McVay · Industry
Who this trial is looking for
This trial is looking for hospitalized patients with swelling in both legs caused by conditions like heart failure or kidney disease. Participants will receive 10 minutes of treatment using a device called the Pedal Pump.
Are You a Good Fit for This Trial?
Rules you outActive deep vein thrombosisPregnancySevere osteoporosis
You may be able to join if
I have swelling in both legs due to heart failure or kidney disease.
I am medically stable.
I can lie in a specific position for 10 minutes.
I am currently in the hospital or receiving outpatient care.
I can read the consent form in English or Spanish or have it translated.
You may not be able to join if
I use a hospital bed with a scale built into it.
I have swelling due to lymphedema or lipedema.
I have pressure sores.
I have signs of blood clots in my legs.
I have wounds or infections on my legs or feet.
My blood pressure is uncontrolled.
My heart rate is too high or too low.
I had surgery on my legs or back in the past month.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 allow…
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.
Trial Locations
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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, or other etiologies of fluid overload conditions.
* Medically stable
* Able to remain in Fowler position for 10 minutes
* …
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
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