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Pedal Pump Clinical Trial on Edema V1

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Oklahoma
Hillcrest Medical Center
RECRUITING
Tulsa
Contact Information
Primary
David W McVay, DO
davidwilliammcvay@gmail.com
918-376-0107
Backup
Dorene Taqi
dorene.taqi@hillcrest.com
918-579-1072
Time Frame
Start Date: 2026-08-06
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: David McVay

This content was sourced from clinicaltrials.gov