| NCT ID | NCT07760363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | David McVay |
| Condition | Lower Extremity Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-06 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-08-06 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
David McVay, DO
PRINCIPAL INVESTIGATOR
Hillcrest
Frequently Asked Questions
Who can join the NCT07760363 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lower Extremity Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07760363 currently recruiting?
Yes, NCT07760363 is actively recruiting participants. Contact the research team at davidwilliammcvay@gmail.com for enrollment information.
Where is the NCT07760363 trial being conducted?
This trial is being conducted at Tulsa, United States.
Who is sponsoring the NCT07760363 clinical trial?
NCT07760363 is sponsored by David McVay. The principal investigator is David McVay, DO at Hillcrest. The trial plans to enroll 60 participants.