OsciPulse Device for the Prevention of VTE
Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Thromboembolisms
About this trial
This is an interventional other trial for Venous Thromboembolism
Eligibility Criteria
Inclusion Criteria:
Part 1: Adult over the age of 40, generally healthy without a current foot or ankle injury, no history of diagnosed vascular disease including DVT, PE, VTE, post-phlebetic syndrome, or chronic venous insufficiency, mentally alert and understand English proficiently, able to give informed consent
Part 2: Adult over the age of 18, admitted to the at Penn Presbyterian Medical Center, anticipated decreased level of mobility for at least 6 hours as determined by the clinical team in collaboration with study personnel, mentally alert and understand English proficiently, able to give informed consent.
Exclusion Criteria:
Part 1: injury to the lower limbs, skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device.
Part 2:
Inability or contraindication to applying IPC to both legs such as:
- Evidence of bone fracture in lower extremities
- Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, & ischemic limb in the legs at the site of IPC placement
- Acute ischemia in the lower extremities
- Severe peripheral vascular disease
- Amputated foot or leg on one or two sides
- Compartment syndrome
- Severe lower extremity edema
- Subjects anticipated to require surgical intervention within six (6) hours of admission
- Subjects with history of VTE (DVT or PE)
- Previous vascular surgery
- Pregnancy or within 6 weeks of postpartum period
- Limitation of life support, life expectancy < 7 days or palliative care
- Admitted to an outside hospital more than 24 hours prior to screening
- A head-unit is unavailable for the 6 hours or more
- At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.
Sites / Locations
- Penn Presbyterian Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Group A
Group B
Group A will wear the OsciPulse device for the first 24 hours then switch to the standard IPC device for the second 24 hours.
Group B will wear the standard IPC device for the first 24 hours then switch to the OsciPulse device for the second 24 hours.