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Pedal Pump Clinical Trial on Edema V1

David McVay · NCT07760363

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
1
Study start
August 6, 2026
Record last updated
August 12, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Pedal Pump; Pedal Pump Sham

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Hillcrest Medical Center

    Tulsa, OK 74104

    Site contact: Dorene Taqi · 9185791072 · dorene.taqi@hillcrest.com

Study contacts (from the official record)

  • David W McVay, DO · 918-376-0107 · davidwilliammcvay@gmail.com
  • Dorene Taqi · 918-579-1072 · dorene.taqi@hillcrest.com
All heart & blood pressure studies in Oklahoma →
Pedal Pump Clinical Trial on Edema V1 (NCT07760363) | Bored Studies