Pedal Pump Clinical Trial on Edema V1

NCT07760363 | Recruiting

• 1 other identifier: Hillcrest
• Study Type: interventional
• Target: 60
• 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. 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

Congestive Heart Failure(CHF); Chronic Venous Insufficiency (CVI); Kidney Disease; Lower Extremity Edema

Keywords

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

Outcome Measures

Primary Outcomes (3)

• No Treatment-Related Adverse Events Scoring 3, 4, or 5 on the CTCAE v4.0 scale

  Treatment-related adverse events will be assessed by CTCAE v4.0 on a 1-5 scale: * Grade 1 (Mild): Asymptomatic or mild symptoms. * Grade 2 (Moderate): Minimal, local, or noninvasive intervention indicated. * Grade 3 (Severe): Severe but not immediately life-threatening; hospitalization indicated. * Grade 4 (Life-threatening): Urgent intervention indicated. * Grade 5 (Death): Death related to the AE. Adverse Events monitors will be such as, but not limited to: * New pain * Worsened pain * Dizziness * Blood pressure instability * Skin irritation * Muscle cramping * Abdominal cramping * Anxiety * Nausea * Syncope * Chest pain of cardiac origin * Sustained arrhythmia * Stroke symptoms * Hypoxia * Hypotension Treatment will stop immediately if a Grade 3, 4, or 5 adverse event occurs. The Investigators will keep record of the number of patients having adverse events and their severities.

  10 minutes

• Treatment Tolerability

  ≥95% treatment tolerability (\<5% "aborted" treatments)

  10 minutes

• Change in Lower Extremity Edema

  ≥1 cm change in average lower extremity circumferences

  10 minutes

Secondary Outcomes (2)

• No increase in pain or stress in ≥80% of the treatment group

  10 minutes

• <20% of Treatment Group having Treatment-Related Adverse Events scoring 2 per CTCAE v4.0

  10 minutes

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

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 Mover

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, 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:

• 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

Sponsors & Collaborators

• David McVay: lead

Study Sites (1)

Hillcrest Medical Center

Tulsa, Oklahoma, 74104, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Kidney Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• David McVay, DO

  Hillcrest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David W 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 INVESTIGATOR
• PI Title: Primary Investigator - Hospitalist Physician - Sponsor

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 12, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anticipated Start-Date: October 31, 2026 Anticipated End-Date: 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)