Pedal Pump Device for Lower Extremity Edema in Hospitalized Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study evaluates a pedal pump device used for 10 minutes to treat bilateral lower extremity edema in hospitalized patients. Patients are positioned in Fowler's position and receive the device treatment on both feet, with assessments before, after, and at follow-up to gauge tolerability and edema changes. The trial includes a sham pedal pump arm for comparison and examines whether the device can be tolerated in a hospital setting and whether it lowers leg fluid volume. The study is conducted at Hillcrest Medical Center in Tulsa, Oklahoma, led by David McVay, with eligibility focused on clinically edema due to CHF, CVI, kidney disease, or fluid overload.

Why it matters

Who can join: the full rules

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's running

• Hillcrest Medical Center
  Tulsa, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: David McVay, DO — Hillcrest
• Study coordinator: David W McVay, DO
• Email: davidwilliammcvay@gmail.com
• Phone: 918-376-0107

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pedal Pump for leg edema in hospitalized patients

  A device-based test to see if a 10-minute Pedal Pump treatment can help reduce leg swelling in hospitalized patients with edema due to conditions like heart failure or venous problems.

  Recruiting Hillcrest · Tulsa, Oklahoma · NCT07809516

• Structured Home-Based Exercise and Education for Chronic Venous Insufficiency

  A home-based exercise and education program is being tested to see if it can improve quality of life and leg symptoms for adults with chronic venous insufficiency compared with standard care.

  Recruiting Abant Izzet Baysal University · Bolu, Bolu · NCT07777978

• Adapting and testing PEN-Plus in Zambian primary care

  Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.

  Recruiting Centre for Infectious Disease Research in Zambia · Lusaka, Lusaka Province · NCT07753681

• Effects of general vs spinal-epidural anesthesia on kidney transplant biomarkers

  This study tests whether sevoflurane general anesthesia or combined spinal-epidural anesthesia changes markers of cellular stress and protective peptides in adults undergoing kidney transplantation.

  Recruiting University of Gaziantep · Gaziantep, State/Province · NCT07678073

• Impact of a Clinical Information System on hospital outcomes for adults with chronic diseases

  This study tests whether implementing a Clinical Information System helps reduce readmissions or death within 30 days after hospital discharge for adults with chronic conditions in Alberta.

  Recruiting University of Calgary · Calgary, Alberta · NCT07609381

• GSK4771261 in Healthy Adults Aged 25–55 in Asia and Europe

  This study tests whether GSK4771261 is safe and how it behaves in the body of healthy adults to see if it could be used safely in the future.

  Recruiting Phase 1 GlaxoSmithKline · Groningen · NCT07600450

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.