Peripheral Artery DiseaseNCT04514861
Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2
A study testing Wireless Lumee Oxygen Platform in people with Peripheral Artery Disease, run by Profusa, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Wireless Lumee Oxygen Platform
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Dec 2020to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
San Francisco General Hospital
San Francisco, California, 94110
San Francisco Veterans Affairs Medical Center (SFVAMC)
San Francisco, California, 94121
UCSF Medical Center
San Francisco, California, 94143
About this study
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)
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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Wireless Lumee Oxygen Platform
- Keywords
- Peripheral Arterial Disease, Tissue Oxygen Monitoring, TcPO2
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless Lumee Oxygen PlatformDevice
The Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue
| Study group | Role | What they receive |
|---|---|---|
| Tissue Oxygen Dynamics with Lumee Oxygen and TcPO2 | Other | Monitoring local subcutaneous tissue oxygen dynamics using the Wireless Lumee Oxygen Platform in correlation to TcPO2 measurements in the arm and foot Receives: Device: Wireless Lumee Oxygen Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the arm
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.
Measured: At 2 days (±1 day) after injection and at 3 months (±14 days) after injection
Secondary outcomes (1)
Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the foot
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.
Measured: 1-14 days after hydrogel insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start18 Dec 2020
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, non-randomized, effectiveness and performance study with confirmatory device in subjects with PAD
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Profusa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Monica M Lozano, PhD, Study director, Profusa, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514861
- Sponsor's protocol ID
- TP0139
- Other IDs
- 4R44HL131366-02, CFDA Number: 93.837
- Status last verified
- Nov 2025
- First submitted
- 27 Jul 2020
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Montero-Baker MF, Au-Yeung KY, Wisniewski NA, Gamsey S, Morelli-Alvarez L, Mills JL Sr, Campos M, Helton KL. The First-in-Man "Si Se Puede" Study for the use of micro-oxygen sensors (MOXYs) to determine dynamic relative oxygen indices in the feet of patients with limb-threatening ischemia during endovascular therapy. J Vasc Surg. 2015 Jun;61(6):1501-9.e1. doi: 10.1016/j.jvs.2014.12.060.
PubMed 26004327Chien JS, Mohammed M, Eldik H, Ibrahim MM, Martinez J, Nichols SP, Wisniewski N, Klitzman B. Injectable Phosphorescence-based Oxygen Biosensors Identify Post Ischemic Reactive Hyperoxia. Sci Rep. 2017 Aug 15;7(1):8255. doi: 10.1038/s41598-017-08490-0.
PubMed 28811566Wisniewski NA, Nichols SP, Gamsey SJ, Pullins S, Au-Yeung KY, Klitzman B, Helton KL. Tissue-Integrating Oxygen Sensors: Continuous Tracking of Tissue Hypoxia. Adv Exp Med Biol. 2017;977:377-383. doi: 10.1007/978-3-319-55231-6_49.
PubMed 28685468Nichols SP, Balaconis MK, Gant RM, Au-Yeung KY, Wisniewski NA. Long-Term In Vivo Oxygen Sensors for Peripheral Artery Disease Monitoring. Adv Exp Med Biol. 2018;1072:351-356. doi: 10.1007/978-3-319-91287-5_56.
PubMed 30178370Kanick SC, Schneider PA, Klitzman B, Wisniewski NA, Rebrin K. Continuous monitoring of interstitial tissue oxygen using subcutaneous oxygen microsensors: In vivo characterization in healthy volunteers. Microvasc Res. 2019 Jul;124:6-18. doi: 10.1016/j.mvr.2019.02.002. Epub 2019 Feb 8.
PubMed 30742844
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04514861
- Acronym / sponsor ID
- TP0139
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Arterial Disease, Tissue Oxygen Monitoring, TcPO2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Profusa, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, non-randomized, effectiveness and performance study with confirmatory device in subjects with PAD
| Arm | Type | Receives |
|---|---|---|
| Tissue Oxygen Dynamics with Lumee Oxygen and TcPO2 | Other | Device: Wireless Lumee Oxygen PlatformMonitoring local subcutaneous tissue oxygen dynamics using the Wireless Lumee Oxygen Platform in correlation to TcPO2 measurements in the arm and foot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wireless Lumee Oxygen PlatformThe Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue | Device | Tissue Oxygen Dynamics with Lumee Oxygen and TcPO2 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Background: PubMed 26004327Montero-Baker MF, Au-Yeung KY, Wisniewski NA, Gamsey S, Morelli-Alvarez L, Mills JL Sr, Campos M, Helton KL. The First-in-Man "Si Se Puede" Study for the use of micro-oxygen sensors (MOXYs) to determine dynamic relative oxygen indices in the feet of patients with limb-threatening ischemia during endovascular therapy. J Vasc Surg. 2015 Jun;61(6):1501-9.e1. doi: 10.1016/j.jvs.2014.12.060.
- Background: PubMed 28811566Chien JS, Mohammed M, Eldik H, Ibrahim MM, Martinez J, Nichols SP, Wisniewski N, Klitzman B. Injectable Phosphorescence-based Oxygen Biosensors Identify Post Ischemic Reactive Hyperoxia. Sci Rep. 2017 Aug 15;7(1):8255. doi: 10.1038/s41598-017-08490-0.
- Background: PubMed 28685468Wisniewski NA, Nichols SP, Gamsey SJ, Pullins S, Au-Yeung KY, Klitzman B, Helton KL. Tissue-Integrating Oxygen Sensors: Continuous Tracking of Tissue Hypoxia. Adv Exp Med Biol. 2017;977:377-383. doi: 10.1007/978-3-319-55231-6_49.
- Background: PubMed 30178370Nichols SP, Balaconis MK, Gant RM, Au-Yeung KY, Wisniewski NA. Long-Term In Vivo Oxygen Sensors for Peripheral Artery Disease Monitoring. Adv Exp Med Biol. 2018;1072:351-356. doi: 10.1007/978-3-319-91287-5_56.
- Background: PubMed 30742844Kanick SC, Schneider PA, Klitzman B, Wisniewski NA, Rebrin K. Continuous monitoring of interstitial tissue oxygen using subcutaneous oxygen microsensors: In vivo characterization in healthy volunteers. Microvasc Res. 2019 Jul;124:6-18. doi: 10.1016/j.mvr.2019.02.002. Epub 2019 Feb 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica M Lozano, PhD study director
Profusa, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless Lumee Oxygen Platform in people with Peripheral Artery Disease, run by Profusa, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04514861, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.