Study of Pedal Pump Device Treatment for Lower Leg Swelling in Hospitalized Adults Assessing Safety, Tolerance, and Effectiveness in Reducing Edema

What this Trial Is About

Researchers are studying the effects of the Pedal Pump device on hospitalized patients with lower extremity edema, a condition often caused by congestive heart failure, chronic venous insufficiency, kidney disease, or other fluid overload conditions. This early-stage clinical trial aims to evaluate whether the Pedal Pump is a feasible and tolerable treatment and whether it can reduce swelling in the lower legs. The trial is randomized and includes a control group receiving a sham treatment. Participants will receive treatment while lying in a bed with the head elevated at a 45-60 degree angle. The Pedal Pump device applies gentle, rhythmic pressure to both feet for 10 minutes to mobilize the body, and the control group experiences a sham device that looks and sounds similar but does not mobilize the legs or body. Measurements are taken before, immediately after, and 45-60 minutes post-treatment to assess edema and symptoms. Both groups continue their usual care including diuretics. During the study, participants will be assessed for foot and leg swelling, skin condition, pain, and other symptoms using objective measurements and patient ratings before and after treatment. Researchers will compare changes in leg circumferences and symptom scores between groups. Safety and tolerability will be monitored, and patient feedback on treatment perception will be collected. Total participation involves one treatment session and follow-up measurements within about an hour.

Pedal Pump Clinical Trial on Edema V1