Recruiting

Pedal Pump

Sponsor:

David McVay

Code:

NCT07760363

Conditions

Lower Extremity Edema

Congestive Heart Failure(CHF)

Chronic Venous Insufficiency (CVI)

Kidney Disease

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.

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.

Conditions

Lower Extremity Edema

Congestive Heart Failure(CHF)

Chronic Venous Insufficiency (CVI)

Kidney Disease

Study ID

NCT07760363

Start date

Aug 6, 2026

Status verified date

Aug, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

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, 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

Study Design

Enrollment

60 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...

1. 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.
2. The heel protector pillows being attached to their feet and the Pedal Pump being placed at the foot of the bed.
3. 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.
4. 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

  • No Treatment-Related Adverse Events Scoring 3, 4, or 5 on the CTCAE v4.0 scale [ Time Frame: 10 minutes ]
  • Treatment Tolerability [ Time Frame: 10 minutes ]
  • Change in Lower Extremity Edema [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

David W 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 W McVay, DO

More Information

Sponsor

David McVay

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Pedal Pump
  • Lower Extremity Edema
  • Congestive Heart Failure
  • CHF
  • LE Edema

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by David McVay on 2026-08-12.