Pedal Pump Clinical Trial on Edema V1

Part of paid clinical trials in Tulsa, Oklahoma.

Sponsor
David McVay
Study ID
NCT07760363
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 12, 2026
Start date
Aug 6, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

No Treatment-Related Adverse Events Scoring 3, 4, or 5 on the CTCAE v4.0 scale [ Time Frame: 10 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hillcrest Medical CenterTulsaOklahoma74104
Dorene Taqi
[email protected]
9185791072
David W McVay, DO (PRINCIPAL_INVESTIGATOR)
John Gemma, DO (SUB_INVESTIGATOR)

Find similar trials in Tulsa, OK

By research site
Hillcrest Medical Center· Tulsa, OK

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