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Active, Not Recruiting

NCT Number: NCT04514861

Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Wireless Lumee Oxygen Platform

Device

The Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue

Primary outcomes

  1. Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the arm

    Time frame: At 2 days (±1 day) after injection and at 3 months (±14 days) after injection

    Correlation of measurements between subcutaneous tissue oxygen concentration expressed by the Lumee Oxygen Index (LOI; unitless; measured by the Wireless Lumee Oxygen Platform) and transcutaneous partial pressure of oxygen (TcPO2; mmHg; measured by the Periflux System 5000 or Periflux System 6000) in the arm during changes of oxygen induced by pressure cuff.

Secondary outcomes

  1. Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the foot

    Time frame: 1-14 days after hydrogel insertion

    Correlation of measurements between subcutaneous tissue oxygen concentration expressed by the Lumee Oxygen Index (LOI; unitless; measured by the Wireless Lumee Oxygen Platform) and transcutaneous partial pressure of oxygen (TcPO2; mmHg; measured by the Periflux System 5000 or Periflux System 6000) in the foot during changes of oxygen induced by pressure cuff.

Other outcomes

  1. Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the arm and foot

    Time frame: Throughout 12 months.

    Correlation of measurements between subcutaneous tissue oxygen concentrations expressed by the unitless Lumee Oxygen Index (LOI; measured by the Wireless Lumee Oxygen Platform) and transcutaneous partial pressure of oxygen (TcPO2; measured by the Periflux System 5000 or Periflux System 6000) in arm and foot during changes of oxygen induced by pressure cuff and positional maneuvers at various timepoints.

  2. Occurrence of Adverse Events

    Time frame: Throughout 12 months and during all unscheduled visits

  3. Lumee™ Patch and Lumee™ Oxygen hydrogel placement site skin observations

    Time frame: Throughout 12 months and during all unscheduled visits

    Skin observations will follow a grading system for Erythema, Edema and Hematoma at the injection site and the skin area where the Lumee Patches were adhered. The scores rank from 0= No Edema/Erythema/Hematoma, 1= very slight, 2 = well-defined, 3=moderate to 4= severe. Incidences of these ranks will we analyzed.

Sponsors and collaborators

Lead sponsor

Profusa, Inc.

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Aug 17, 2020
Registry last updated
Nov 12, 2025

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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