Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow

This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device. The study will enroll healthy human subjects who will have their deep venous blood flow measured by vascular ultrasound during immobility, use of the OsciPulse system, and use of two reference vascular compression devices. Our hypothesis is that the OsciPulse system will create distinct patterns of venous flow, specifically at the site of venous valves, in comparison to the reference compression devices.

Enrolled healthy subjects will undergo and initial vascular ultrasound imaging procedure to locate a deep venous valve in either the sapheno-femoral junction or femoral trifurcation sites. Once the imaging valve is identified the baseline level of venous flow will be collected in 30 s video clips of 2D color Doppler videos and spectral Doppler. Next, either the OsciPulse device, or one of the two reference therapy devices, will be applied by study personnel according to the device's specific instructions. The subject will wear the device during the capture of 1 spectral Doppler clip and three 30 s 2D color Doppler ultrasound clips on both the left and right leg. Next, the remaining two devices will be applied based on instructions, and vascular ultrasound clips captured for each. Completion of this visit protocol will be the end of the study.

In this single arm study all enrolled subjects will the intervention by the investigational device, and both reference devices. Ultrasound will be used to measure the blood flow in the subject during the use of all three devices.

The OsciPulse system is an intermittent pneumatic limb compression system. The OsciPulse sleeves that are applied to the top portion of the user's calves and are periodically inflated with rapid bursts of compressed air to create frequent pulses of venous return.

The Venaflow Elite is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Venaflow system sleeves cover the entire calf region of the user and contain two bladders that are inflated sequentially to induce venous return.

The Kendall SCD device is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Kendall SCD sleeves cover the entire calf region of the user and contain three bladders that are inflated sequentially to induce venous return.

The volume flow index (mL/mL) will be measured for flow in the valve sinus region that is moving back towards the heart (forward flow). The venous flow at a valve will be measured using 2D color Doppler ultrasound, and flow volume index calculated from the resulting video clips.

The volume flow index (mL/mL) will be measured for flow in the valve sinus region that is moving away from the heart (reversing flow). The venous flow at a valve will be measured using 2D color Doppler ultrasound, and flow volume index calculated from the resulting video clips.

The degree of red blood cell rouleaux in the sinus of venous valves will be measured using B-mode ultrasound.

Inclusion Criteria: Adult age ≥40 years old Generally healthy. No history of diagnosed vascular disease including: DVT, PE, VTE, peripheral vascular disease, post-phlebitic syndrome, or chronic venous insufficiency. Mentally alert and understand English proficiently. Able to give informed consent. Exclusion Criteria: Skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device or reference therapies. Severe peripheral artery or venous disease.

The data will become available starting 6 months after publication of the study and will be available for 24 months upon request.

Qualifying IPD will be shared with specific requestors if they are at an academic or government institution and to be used for non-commercial research. Requests will be evaluated by OsciFlex LLC.