REDIEM 2.0 - Renal Extremity Device to measure Impedance, Edema and Movement

Project Background/Scope: Kidney disease leading to chronic kidney disease (CKD) and eventually kidney failure is a leading cause of death that is on the rise in the U.S. Kidney disease affects an estimated 37 million people in the U.S. (15% of the adult population; more than 1 in 7 adults). Approximately 90% of those with kidney disease don't know they have it! 1 in 3 adults in the U.S. (approximately 80 million) is at risk for kidney disease. Kidney disease is more common in women (14%) than men (12%). But for every 2 women who develop end-stage kidney disease (ESKD), 3 men’s kidneys fail.

Impedance (water content) and Edema (swelling): The delicate balance of fluid and blood circulating in the body is maintained through healthy function of the heart and kidneys, amongst other organs. If disease strikes these organs, fluid tends to migrate from within the vascular space (blood vessels) into soft tissues causing swelling (edema) and regional dysfunction. As humans largely exist in an upright fashion this fluid, because of gravity, tends to accumulate in the lower extremities. Having a device able to readily measure the water content of the leg as well as the edema (swelling) that develops will be an advance that can impact the lives of many patients, guiding therapy for fluid removal.

Movement: Additionally, many CKD patients and those on dialysis develop Restless Leg Syndrome (RLS) - a condition of overwhelming urge to move the legs during rest, which can be relieved temporarily by movement. Symptoms of RLS are estimated to affect up to 25% of patients on dialysis RLS has been associated with an increase in sleep disturbance, higher cardiovascular morbidity, decreased quality of life, and an increased risk of death in patients with CKD. Developing a sensor system able to measure the degree of leg movement, and record its extent and frequency will be of great value in managing this morbid condition. This sensor will be incorporated in an integrated device measuring water and edema.

Requirements: 1. Develop a system to measure the impedance of the lower extremity to determine leg water, relative to body water; 2. A series of stretch sensors incorporated in a stocking-like device to measure swelling at a given level of the leg; 3. Incorporated accelerometers to measure movement of legs – determining extent, frequency and pattern over time; 4. A software module and graphical user interface to provide data processing, readout, storage and telemetry of the data.