Pedal Pump Clinical Trial on Edema V1
Recruiting · NCT07760363 · Interventional (participants receive a specific treatment) · Lead sponsor: David McVay
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
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
Where it is running
2 locations listed across 1 US state.
- Hillcrest Medical Center - Tulsa, Oklahoma, United States
- Hillcrest Medical Center - Tulsa, Oklahoma, United States