Pedal Pump for leg edema in hospitalized patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a Pedal Pump device used on both feet for 10 minutes with patients who have bilateral lower extremity edema. The trial aims to determine if the device is tolerable for hospitalized patients and whether it reduces edema, measured by standard edema grading. It uses a feasibility design with an intervention and a sham control to gather objective edema data by occupational therapists. Participants must be medically stable, able to sit in a Fowler position for 10 minutes, and able to consent. The study is conducted at Hillcrest Medical Center in Tulsa, Oklahoma, led by Hillcrest with no listed collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• Hillcrest Medical Center
  Tulsa, Oklahoma, United States Recruiting

Study contacts

• Study coordinator: David McVay, DO
• Email: davidwilliammcvay@gmail.com
• Phone: 918-376-0107

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.