Clinical Research Directory

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