Pedal Pump Clinical Trial on Edema V2

Conditions

• CHF - Congestive Heart Failure
• CHF Exacerbation
• Chronic Venous Insufficiency, CVI
• Lower Extremity Edema
• Lower Extremity Edema Chronic

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, almost the same as Pedal Pump Clinical Trial on Edema V1 that is underway; however, this study focuses primarily on the objective data gathered by trained Occupational Therapists who regularly measure lower extremities. Key Question for this second 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

Sep 9, 2026

Start date

Aug 21, 2026

Status verified

Sep 2026

Primary completion

Apr 30, 2027

Completion

May 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group
  The Treatment group will experience the Pedal Pump intervention by... * 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. * The heel protector pillows being attached to their feet and the Pedal Pump being placed at the foot of the bed. * 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. * 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

Treatment Tolerability in at least 19 of the 20 patients in the Pedal Pump treatment group [ Time Frame: 10 minutes ]

Central Contacts

• David McVay, DO
  918-376-0107
  [email protected]
• Dorene Taqi
  918-579-1072
  [email protected]

Locations (1)

Find similar trials in Tulsa, OK

Related Studies

• Pedal Pump Clinical Trial on Edema V1
  Recruiting · David McVay · Tulsa, Oklahoma