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NCT Number: NCT05087108

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.

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Key information

Conditions

Venous Thromboses Cardiovascular Diseases Embolism and Thrombosis Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Thrombosis Varicose Ulcer Varicose Veins Vascular Diseases Venous Stasis Venous Thrombosis

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OsciPulse system

Device

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.

Reference Therapy 1

Device

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

Refence Therapy 2

Device

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

Primary outcomes

  1. Venous valve sinus forward flow volume index

    Time frame: Visit 1 - 60 minutes

    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.

  2. Venous valve sinus reversing flow volume index

    Time frame: Visit 1 - 60 minutes

    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.

  3. Deep vein centerline flow

    Time frame: Visit 1 - 60 minutes

    The velocity of venous flow measured by spectral Doppler ultrasound in the deep femoral vein.

  4. Venous valve sinus rouleaux

    Time frame: Visit 1 - 60 minutes

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

Sponsors and collaborators

Lead sponsor

OsciFlex LLC

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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