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First received: August 12, 2024

Clinical Trial: Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Diabetic Foot Ulcer

Study Type: INTERVENTIONAL


Official Title: A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Unique Advanced Bioengineered Skin Substitute With Standard of Care Versus an Active Comparator With Standard of Care in the Treatme

Brief Summary: The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute.The commercially available product is Helicoll® Advanced Skin Substitute.In this trial two groups of subjects with Wagner 1 diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition.Half of the patients will have their SOC treatment with Epifix® or Grafix® and the other half will receive a 510K FDA cleared Helicoll® Advanced Skin…

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