Recruiting

Pedal Pump

Sponsor:

Hillcrest

Code:

NCT07809516

Conditions

Lower Extremity Edema

Lower Extremity Edema Chronic

CHF - Congestive Heart Failure

CHF Exacerbation

Chronic Venous Insufficiency, CVI

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pedal Pump

Pedal Pump Sham

Study Details

Brief summary:

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.

Conditions

Lower Extremity Edema

Lower Extremity Edema Chronic

CHF - Congestive Heart Failure

CHF Exacerbation

Chronic Venous Insufficiency, CVI

Study ID

NCT07809516

Start date

Aug 21, 2026

Status verified date

Sep, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

The Treatment group will experience the Pedal Pump intervention by...

  • Being assisted to sit up in their beds at a 45-60 degree Fowler's position. Their thighs, calves, and ankles being marked with a surgical marker at the locations and measured.
  • The heel protector pillows being attached to their feet and the Pedal Pump being placed at the foot of the bed.
  • Provided the treatment is tolerated by the patient, the Pedal Pump treatment being applied to both feet for 10 minutes continuously mobilizing their whole body in sufficient manner to see the nose move.
  • The Operator turning off the device and removing it from the bed.

sham comparator: Sham (Control) Group

The Sham Group will have the same experience as Treatment Group with the exact same device generating identical operational sounds and visible movement, but the patient's body will not be close enough to the device to produce sufficient displacement to transmit mechanical forces beyond the feet. The Pedal Pump will only contact the heel protector pillows enough to make the toes move but will not contact them enough to mobilize the legs or the entire body.

Interventions

Pedal Pump

The Pedal Pump device pumps both feet for 10 minutes continuously-- mobilizing their whole body in sufficient manner to see the nose move.

Pedal Pump Sham

The Sham Intervention is the same as Pedal Pump Intervention with the exact same Pedal Pump device generating identical operational sounds and visible movement; however, the patient's body will not be close enough to the device to produce sufficient displacement to transmit mechanical forces beyond the feet. The Pedal Pump will only contact the heel protector pillows enough to make the toes move but will not contact them enough to mobilize the legs or the entire body.

Primary outcome measure

  • Treatment Tolerability in at least 19 of the 20 patients in the Pedal Pump treatment group [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

David McVay, DO

918-376-0107davidwilliammcvay@gmail.com

Dorene Taqi

918-579-1072dorene.taqi@hillcrest.com

Locations

Hillcrest Medical Center

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

Dorene Taqi

9185791072dorene.taqi@hillcrest.com

Principal Investigator:

David McVay, DO

More Information

Sponsor

Hillcrest

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Pedal Pump
  • Lower extremity edema
  • leg swelling
  • LE Edema
  • Congestive Heart Failure
  • CHF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hillcrest on 2026-09-09.