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Pedal Pump Clinical Trial on Edema V1

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 a 10-minute Pedal Pump device treatment is practical to use and can reduce swelling in both legs. It is for medically stable patients with swelling from fluid buildup who are in the hospital, emergency room, observation care, or an outpatient clinic.

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.

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 that a treating clinician says is from fluid buildup, such as from heart failure, kidney disease, or poor blood flow through leg veins.
  • Be medically stable.
  • Be able to stay in a partly sitting position with the upper body raised for 10 minutes.
  • Be in the emergency room, observation care, or hospital, or be an outpatient, including a heart failure clinic patient.
  • Agree to join after reading the consent form in English or Spanish, or after having it translated.

Who can't join

  • Use a hospital bed with a scale on the footboard.
  • Have lymphedema (swelling from trapped lymph fluid), including fluid leaking through the skin, or lipedema (unusual fat buildup).
  • Have pressure sores, wounds or infections on the feet, legs, buttocks, or back, or a skin infection with blisters.
  • Have an active deep vein blood clot. Sudden swelling in one leg requires an ultrasound during the current hospital stay showing no clot before joining.
  • Have blood vessel disease outside the heart that causes symptoms.
  • In the past 2 hours, have blood pressure above 180/110 or below 80/45, or a heart rate above 110 or below 45.
  • Have had leg or back surgery in the past 30 days, or be known to be pregnant.
  • Have severe osteoporosis (weak 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, 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

Study sites (1)

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