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

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 lowerextremity revascularization

• Has been informed of the nature of the study, agrees to its provisions, and hassigned the informed consent form prior to any study related procedure

• Should plan to be available for all safety follow-up examinations at theinvestigational site

• Is aware that the Lumee™ Oxygen hydrogels are intended to stay in the tissueindefinitely

• Is aware that photos of injection sites and wound site will be taken, and videos maybe 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 influencedevice 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 orfoot or chronic venous stasis changes (CEAP clinical score ≥ 3)

• Any condition that at the discretion of the investigator, physician or designee willimpact 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 theparticipation in this study

• Subject requires dialysis

• Subject is immunocompromised

• Subject has incompressible arteries tested by occlusion test in the arm

• Inability to obtain consent