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

Brief description of study

The purpose of this study is to evaluate the safety and efficacy of weekly applications on GrafixPL ™PRIME, in patients with a venous leg ulcer that has been present for at least 4 weeks. This is a study for patients who have been diagnosed as having a chronic venous leg ulcer. Venous leg ulcers (VLUs) are sores that may occur on the lower leg (usually above the ankle and below the calf) in people with poor circulation. GrafixPL ™PRIME, the product being studied, is regulated for use in the United States by the Food and Drug Administration (FDA). GrafixPL ™PRIME can be used by doctors for application directly to chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure sores, as well as acute wounds caused by surgical incisions, burns, and trauma.

Clinical Study Identifier: s18-01382
ClinicalTrials.gov Identifier: NCT03629236

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