Pedal Pump Clinical Trial on Edema V2

NCT07809516 | Recruiting

• 1 other identifier: Hillcrest V2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Treatment Tolerability in at least 19 of the 20 patients in the Pedal Pump treatment group

  ≥95% of the subjects receiving the Pedal Pump treatment finished the 10 minutes of treatment without stopping it because of adverse effects (\<5% "aborted" treatments).

  10 minutes

Secondary Outcomes (1)

• Change in Lower Extremity Edema in the Pedal Pump treatment group

  10 minutes

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Device: Pedal Pump

Sham (Control) Group

SHAM COMPARATOR

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.

Device: Pedal Pump Sham

Interventions

Pedal Pump DEVICE

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

Also known as: Foot Pump, Foot Mobilizer, Feet Mobilizer

Treatment Group

Pedal Pump Sham DEVICE

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.

Sham (Control) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hillcrest: lead

Study Sites (1)

Hillcrest Medical Center

Tulsa, Oklahoma, 74104, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Blindness, Cortical

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David McVay, DO

CONTACT

918-376-0107; davidwilliammcvay@gmail.com

Dorene Taqi

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 9, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: March 30, 2027 - January 1, 2040
• Access Criteria: After publication, de-identified IPD will be shared with qualified independent researchers under strict data-use agreements to verify findings and conduct new scientific work. We will allow said researchers to have "view only" access to the electronic folder containing the de-identified IPD. Researchers can email their requests to davidwilliammcvay@gmail.com.

Locations

US (1)