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
Trial Parameters
Brief Summary
A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.
Eligibility Criteria
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 cel