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

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ClinicalTrials.gov Identifier: NCT04514861
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : September 20, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Profusa, Inc.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: Wireless Lumee Oxygen Platform Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm, non-randomized, effectiveness and performance study with confirmatory device in subjects with PAD
Masking: None (Open Label)
Primary Purpose: Basic Science
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)
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Tissue Oxygen Dynamics with Lumee Oxygen and TcPO2
Monitoring local subcutaneous tissue oxygen dynamics using the Wireless Lumee Oxygen Platform in correlation to TcPO2 measurements in the arm and foot
 Device: Wireless Lumee Oxygen Platform
The Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514861


Contacts
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Contact: Taylor Noriega, PharmD 415.655.9861 taylor.noriega@profusa.com
Contact: Monica Lozano, PhD 415.655.9861 monica.lozano@profusa.com

Locations
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United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Laura Menke, PhD    415-353-4368    laura.menke@ucsf.edu   
Principal Investigator: Shant Vartanian, MD         
San Francisco Veterans Affairs Medical Center (SFVAMC) Recruiting
San Francisco, California, United States, 94121
Contact: David Cheng    415-221-4810 ext 24708    david.cheng4@va.gov   
Principal Investigator: James C Iannuzzi, MD         
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Laura Menke, PhD    415-353-4368    laura.menke@ucsf.edu   
Principal Investigator: Michael S Conte, MD         
Sponsors and Collaborators
Profusa, Inc.
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Study Director: Kerstin Rebrin, MD, PhD Profusa, Inc.
More Information
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Publications:

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Responsible Party: Profusa, Inc.
ClinicalTrials.gov Identifier: NCT04514861    
Other Study ID Numbers: TP0139
4R44HL131366-02 ( U.S. NIH Grant/Contract )
CFDA Number: 93.837 ( Other Identifier: U.S. Department of Health and Human Services )
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Profusa, Inc.:
Peripheral Arterial Disease
Tissue Oxygen Monitoring
TcPO2
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases