Clinical trial NCT04625673: OsciPulse Device for the Prevention of VTE
Official title: Phase 2, Randomized Study of the Tolerability and Safety of the OsciPulse Device for the Prevention of VTE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Thromboembolisms
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: OsciFlex LLC
First posted: 2020-11-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two part, open-label, randomized, crossover study. Part 1 will enroll 3 healthy subjects. Part two will enroll 15-20 in-patient subjects. Part two will have two arms.

Arm A will wear the OsciPulse then wear the standard IPC device. Arm B will wear the standard IPC device then wear the OsciPulse device.
Primary purpose: OTHER

Brief summary: This is a Phase 2 safety and tolerability trial that will take place in two parts. Part one of the trial will determine the tolerability of the OsciPulse device on healthy subjects who wear the device for up to three hours. Healthy volunteers will answer questionnaires and may undergo an ultrasound test at the end of their participation in the trial.

Part two of the trial will determine the safety and tolerability of the OsciPulse device on subjects admitted to Penn Presbyterian Medical Center. Eligible subjects will be enrolled for 6 hours. In the first 3 hours, subjects will wear the standard of care intermittent pneumatic compression device or the OsciPulse device. In the second 3 hours, the subject's device will be switched and subjects will wear the alternate device not used in the first 3 hours. Subjects will answer questionnaires and may undergo an ultrasound at the end of the first 3 hours and at the end of the second 3 hours (at hour 6).


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:

1. 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
2. Subjects anticipated to require surgical intervention within six (6) hours of admission
3. Subjects with history of VTE (DVT or PE)
4. Previous vascular surgery
5. Pregnancy or within 6 weeks of postpartum period
6. Limitation of life support, life expectancy \< 7 days or palliative care
7. Admitted to an outside hospital more than 24 hours prior to screening
8. A head-unit is unavailable for the 6 hours or more
9. 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.

Primary outcomes:
measure: Part 1 - Subject's Response to Tolerability Questionnaire
timeFrame: up to 3 hours
measure: Part 1 - Safety Assessment Through Collection of Adverse Events
timeFrame: up to 3 hours
measure: Part 2 - Subject's Response to Tolerability Questionnaire
timeFrame: 6 hours
measure: Part 2 - Safety Assessment Through Collection of Adverse Events.
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Adam Cuker, MD
role: PRINCIPAL_INVESTIGATOR
References: