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Foot-Pumping device tested to ease swollen legs

NCT ID NCT07809516

Symptom relief Sponsor: Hillcrest Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing a device called the Pedal Pump, which pumps both feet for 10 minutes to mobilize the body and improve lymphatic flow. The trial enrolls 30 hospitalized patients with lower extremity edema caused by heart failure, chronic venous insufficiency, kidney disease, or other fluid overload conditions. The main goal is to see whether patients can tolerate the treatment, and a secondary goal is to measure whether it reduces leg swelling. This is an early-stage study, and the investigators expect further testing and product improvements.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pedal Pump, a device that pumps both feet to mobilize the body and improve lymphatic flow
What this could lead to
If it works, the Pedal Pump could offer a consistent, device-based way to ease leg swelling for hospitalized patients, without relying on a human therapist.
What could go wrong
This is a small, early-stage study of 30 patients, so results may not hold in larger groups. The device is still being developed, and some participants may not tolerate the 10-minute treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency congestive heart failure cortical blindness heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHF - congestive heart failure CHF exacerbation Chronic venous insufficiency, cvi Lower extremity edema Lower extremity edema chronic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hillcrest Medical Center

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

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