Organogenesis
This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus Standard of Care Alone in subjects with chronic DFUs.
At least 170 subjects with a chronic DFU will be randomized 1.4:1:1 to the SOC group, PuraPly AM + SOC, or PuraPly XT + SOC. Following screening and randomization, subjects shall be seen weekly for up to 12 weeks. For subjects that heal, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.
Inclusion Criteria: 1. At least 18 years of age or older. 2. Diagnosis of type 1 or 2 Diabetes mellitus. 3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 4. The target ulcer must have been present for a minimum of 4 weeks 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 Wagner 1 or 2 grade 7. The affected limb must have adequate perfusion confirmed by vascular assessment. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying th…
Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change.
PuraPly Antimicrobial Wound Matrix is a 2-layer cross-linked extracellular matrix (PCMP) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB)
PuraPly Antimicrobial XT Wound Matrix is a 5- layer cross-linked extracellular matrix (PCMP) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB)
Arctuva estimate
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