A Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers

Inclusion Criteria: * The potential subject must be at least 18 years of age or older. * The potential subject must agree to attend the weekly study visits required by the protocol. * The potential subject must be willing and able to participate in the informed consent process. * The potential subject must have a full thickness pressure ulcer NPIAP stage 3 through stage 4 without exposed bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial). * At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100 cm2 measured post debridement with the imaging device. * The potential subject has adequate off-loading of the ulcer. Exclusion Criteria: * The potential subject is known to have a life expectancy of \< 3 months. * The potential subject's target ulcer is not a pressure ulcer. * The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin. * The target ulcer exposes tendon or bone. * There is undermining at the wound edge or tunnelling. * There is evidence of osteomyelitis complicating the target ulcer. * The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics). * The potential…