NCT07760363Recruiting
Pedal Pump Clinical Trial on Edema V1
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 Aug 2026
- Start date
- 6 Aug 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- David McVay
- Diseases
- Heart failure
- NCT number
- NCT07760363
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 6 Aug 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Leg or back surgery in previous 30 days
Other illness
- Symptomatic peripheral vascular disease
- Wounds or infections in the feet, legs, buttocks, or back
- Uncontrolled hypertension (BP\>180/110) in the recent 2 hours
- Heart rate greater than 110 or less than 45 in the recent 2 hours
Other
- 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.)
- Weeping lymphedema or bullous cellulitis
- Uncontrolled hypotension (BP \<80/45) in the recent 2 hours
- Known pregnancy
- Severe osteoporosis/fracture risk
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hillcrest Medical Center Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.