Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Michael S Conte, MD
Photo of Michael S Conte
Michael S Conte

Description

Summary

The purpose of this study is to monitor changes in local tissue oxygen levels in participants with Peripheral Artery Disease (PAD) using the Wireless Lumee Oxygen Platform. A transcutaneous oxygen pressure (TcPO2) device is used to show correlations in oxygen dynamics. Oxygen dynamics are induced by a pressure cuff and position maneuvers. Study participants will participate in the study for 12 months with six (6) planned visits over the course of the study. The investigational device, the Wireless Lumee Oxygen Platform, consists of the Lumee Oxygen, a sterile soft injectable oxygen-sensitive hydrogel, designed to sense and report oxygen levels in the subcutaneous tissue. After initial insertion of the hydrogel in the subcutaneous tissue using the Lumee Pen (a sterile disposable injector device), tissue oxygen levels can be monitored continuously using the Lumee Patch (a non-invasive, non-sterile, wireless electronic device to collect, analyze and report tissue oxygen levels sensed by Lumee Oxygen Hydrogel) attached to the skin through the Lumee Patch Adhesive (designed to adhere the Lumee Patch). The Lumee Patch sends collected tissue oxygen data to the Lumee App which displays the collected data and operates up to four Lumee Patches.

Official Title

Effectiveness of Measuring Local Tissue Oxygen in Response to Induced Hemodynamic Changes With the Profusa's Wireless Lumee Oxygen Platform in Patients With Peripheral Artery Disease (PAD)

Keywords

Peripheral Artery Disease Peripheral Arterial Disease Tissue Oxygen Monitoring TcPO2 Wireless Lumee Oxygen Platform

Eligibility

You can join if…

Open to people ages 18 years and up

A suitable candidate must meet the following criteria:

  • Male or female must be ≥ 18
  • Diagnosed with PAD, Rutherford 3 or 4, stable at time of enrollment (stable disease state)
  • No active infection
  • Has been informed of the nature of the study, agrees to its provisions, and has signed the informed consent form prior to any study related procedure
  • Should plan to be available for all safety follow-up examinations at the investigational site
  • Is aware that the Lumee™ Oxygen hydrogels are intended to stay in the tissue indefinitely
  • Is aware that photos of injection sites and wound site will be taken, and videos may be recorded

You CAN'T join if...

A candidate will be excluded from the study if any of the following criteria are met:

  • Known history of keloids, excessive fibrosis during wound healing
  • Known allergies to Lumee™ Oxygen hydrogel components, local anesthetic agents, suture materials, or severe skin allergies to adhesives
  • Any skin or musculoskeletal condition or deformity limiting injection of the Lumee™ Oxygen hydrogel or preventing subsequent attachments of the Lumee™ Patch system
  • Any skin modification in the area of injection that would potentially influence device performance (for example tattoos or scars)
  • No previous amputation related to the affected limb
  • Significant venous insufficiency resulting in swelling of the lower leg, ankle or foot or chronic venous stasis changes (CEAP clinical score ≥ 3)
  • Any condition that at the discretion of the investigator, physician or designee will impact the safety of the subject or the scientific integrity of the trial
  • Female subjects of childbearing capacity (not surgically sterile or menopausal for ≥ 1 year)
  • Participation in another clinical study, that would potentially interfere with the participation in this study
  • Subject requires dialysis
  • Subject is receiving immunosuppressive therapy
  • Subject has incompressible arteries tested by occlusion test in the arm
  • Inability to obtain consent

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • SF General Hospital not yet accepting patients
    San Francisco California 94110 United States
  • SF VA Health Care Center not yet accepting patients
    San Francisco California 94121 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Profusa, Inc.
ID
NCT04514861
Study Type
Interventional
Last Updated