Tiny implant could track oxygen in legs of PAD patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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