A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
The potential subject must be at least 18 years of age or older.
The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.
The potential subject must consent to using the prescribed offloading method for the duration of the study.
The potential subject is known to have a life expectancy of < 6 months.
The potential subject's target ulcer is not secondary to diabetes.
The target ulcer is infected or there is cellulitis in the surrounding skin.
The target ulcer exposes tendon or bone.
Single group
XWRAP
Other interventionApplication of XWRAP + standard of care for up to 12 weeks.
Wound Closure
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Time to Closure
Time to closure for the target ulcer.
Wound Area Reduction
Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
Adverse Events
The number of product- or procedure- related adverse events.
Wound Quality of Life
Change in quality-of-Life based on the Wound Quality of Life Questionarie \[Time Frame: TV-1, TV-4, TV-8, TV-12 / Final Visit\].
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Applied Biologics, LLC
Lead sponsor
SerenaGroup, Inc.
Collaborator
