Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Profusa, Inc.
With
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
