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.
Parallel
Standard of Care
Other interventionBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
XPURT + SOC
Other interventionParticipants will receive weekly applications of XPURT and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Complete Closure
The percentage of target ulcers achieving complete wound closure in 20 weeks.
Time to Healing
The time to healing of the target ulcers over 20 weeks.
Percentage of Wound Area Reduction
Percentage wound area reduction from TV-1 to TV-21 measured weekly with digital photographic planimetry, using an Imaging Device, and physical examination.
Adverse Events
The number of product- or procedure- related adverse events.
Measure Pain
Change in pain in the target ulcer assessed from TV-1 to TV-21 using the VAS scale.
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Applied Biologics, LLC
Lead sponsor
SerenaGroup, Inc.
Collaborator
