

A Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL™ Prime for the Treatment of Chronic Venous Leg Ulcers
Physician
Steven Bowers, DO
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Synopsis: The primary objective of the present study is to evaluate the safety and efficacy of weekly administration of GrafixPL™ PRIME plus standard compression therapy versus standard compression therapy alone in patients with chronic VLUs.
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Duplex ultrasonography, or
Principal Investigator [PI] clinical assessment to include clinical signs and symptoms of venous ulcerations (e.g., hyperpigmentation of surrounding skin, varicosities, and/or lipodermatosclerosis ).
In the inclusion criteria above, the word or is meant to include the case where both or multiple criteria are met as well as the case where just a single criterion is met.
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In the exclusion criteria above, the word or is meant to include the case where both or multiple criteria are met as well as the case where just a single criterion is met.
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