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

A Crossover Study of the Hemodynamic Effect of the OsciPulse Device Compared to Reference Therapies

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.

Study Overview

• Status: Completed
• Conditions: Venous Stasis; Venous Thromboses
• Intervention / Treatment: Device: OsciPulse system; Device: Reference Therapy 1; Device: Refence Therapy 2

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study arm; 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.

Device: OsciPulse system; 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.; Device: Reference Therapy 1; 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.; Other Names: Venaflow Elite Vascular System; Device: Refence Therapy 2; 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.; Other Names: Kendall 700 Series SCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous valve sinus forward flow volume index	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.	Visit 1 - 60 minutes
Venous valve sinus reversing flow volume index	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.	Visit 1 - 60 minutes
Deep vein centerline flow	The velocity of venous flow measured by spectral Doppler ultrasound in the deep femoral vein.	Visit 1 - 60 minutes
Venous valve sinus rouleaux	The degree of red blood cell rouleaux in the sinus of venous valves will be measured using B-mode ultrasound.	Visit 1 - 60 minutes

Collaborators and Investigators

• Sponsor: OsciFlex LLC
• Collaborators: University of Pennsylvania; National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Study Director: John Welsh, PhD, OsciFlex LLC; Principal Investigator: Chandra Sehgal, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Venous compression; Intermittent pneumatic compression
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Embolism and Thrombosis; Varicose Veins; Thrombosis; Venous Thrombosis; Varicose Ulcer
• Other Study ID Numbers: OSC-VTE-002; R44HL145860 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Our plan is to make available for sharing all IPD that underlie results in a publication.
• IPD Sharing Time Frame: The data will become available starting 6 months after publication of the study and will be available for 24 months upon request.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No