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

Who can take part

• 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 take part

• Previous amputation proximal to the digital level on the limb included in the study
• Subject has an active infection
• 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
• 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
• 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 open wound on limb included in study
• Any skin modification in the area of injection that would potentially influence device performance (for example tattoos or scars)
• 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