Status:
ACTIVE_NOT_RECRUITING
Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2
Lead Sponsor:
Profusa, Inc.
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04514861
Start Date
December 18 2020
End Date
March 30 2028
Last Update
November 12 2025
Active Locations (3)
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1
San Francisco General Hospital
San Francisco, California, United States, 94110
2
San Francisco Veterans Affairs Medical Center (SFVAMC)
San Francisco, California, United States, 94121
3
UCSF Medical Center
San Francisco, California, United States, 94143