for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Shant Vartanian, MDJames C Iannuzzi, MDMichael S Conte, MD
Headshot of Shant Vartanian
Shant Vartanian
Headshot of James C Iannuzzi
James C Iannuzzi
Headshot of Michael S Conte
Michael S Conte



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)


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


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 years of age
  • Diagnosed with PAD, stable at time of enrollment, and may include prior stable lower extremity revascularization
  • 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:

  • PAD of Rutherford Classification 5 or 6 at time of enrollment
  • Subject has an active infection
  • Subject has an open wound on limb included in study
  • 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)
  • Previous amputation proximal to the digital level on the limb included in the study
  • 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 immunocompromised
  • Subject has incompressible arteries tested by occlusion test in the arm
  • Inability to obtain consent


  • San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States
  • San Francisco Veterans Affairs Medical Center (SFVAMC) accepting new patients
    San Francisco California 94121 United States
  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States

Lead Scientists at UCSF

  • Shant Vartanian, MD
    The enhanced longevity of patients living with chronic HIV infection has resulted in an increasing burden of chronic diseases, and while there is growing evidence that HIV infected patients at risk for coronary artery disease at rates of up to two fold higher than the uninfected, the significance of chronic HIV infection in the peripheral vasculature is largely unknown.
  • James C Iannuzzi, MD
    James C. Iannuzzi, M.D., MPH is a vascular surgeon in the Division of Vascular and Endovascular Surgery at UCSF. Dr. Iannuzzi earned his MD at Icahn School of Medicine Mount Sinai, and thereafter completed a general surgery residency at University of Rochester Medical Center where he also earned an MPH. His thesis was on the pleiotropic effects of statins on perioperative outcomes.
  • Michael S Conte, MD
    Professor, Surgery, School of Medicine. Authored (or co-authored) 280 research publications


accepting new patients
Start Date
Completion Date
Profusa, Inc.
Study Type
Expecting 53 study participants
Last Updated