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.
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).
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.
Applied Biologics, LLC
Lead sponsor
SerenaGroup, Inc.
Collaborator