Applied Biologics, LLC
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers
XCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of a single layer amniotic membrane (SLAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). XWRAP® is an allograft membrane derived from human amniotic tissue. Designed to act as a protective barrier, it is effective for DFUs, venous leg ulcers (VLUs), and pressure ulcers \[13\]. The processing of XWRAP® is designed to preserve the structural integrity of the amniotic epithelial membrane \[13\]. The product is screened and tested in a Clinical…
Inclusion Criteria: 1. Subjects must be at least 18 years of age or older, 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement. 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target ulcer must be Wager 1 or 2 grad…
Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Beginning 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 12 weeks, whichever occurs first.
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