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Pedal Pump Clinical Trial on Edema V2

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether 10 minutes of treatment with the Pedal Pump device is practical and helps reduce swelling in both legs. It is for patients with leg swelling who are in the hospital, emergency room, or observation, or who receive care without a hospital stay.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have at least mild swelling in both legs from extra fluid, as judged by your clinician. Causes may include heart failure, poor blood flow in leg veins, kidney disease, or trouble draining lymph fluid.
  • Be medically stable.
  • Be able to lie with your head and upper body raised for 10 minutes.
  • Be in the emergency room, under observation, or staying in the hospital, or receive outpatient care, such as at a heart failure clinic.
  • Agree to join after learning about the study. You must be able to read the consent form in English or Spanish, or give consent after it is translated for you.

Who can't join

  • Swelling caused only by lipedema, a buildup of fat.
  • Pressure sores.
  • An active blood clot in a deep vein. If one leg has sudden swelling, an ultrasound during the current hospital stay must show no clot before you can join.
  • Blood vessel disease in the arms or legs that causes symptoms.
  • Wounds or infections on the feet, legs, buttocks, or back that the trained device operator decides make treatment unsuitable.
  • Leg or back surgery in the past 30 days.
  • Known pregnancy.
  • Severely weakened bones or a high risk of broken bones.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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, lymphedema, 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: * Lipedema (fat distribution) as the only cause for edema * 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 deemed unfit for treatment per the trained Operator. * Leg or back surgery in previous 30 days * Known pregnancy * Severe osteoporosis/fracture risk

Study sites (1)

OK