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Clinical Trials

Topic   Venous Ulcers
Title   A Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPLTM PRIME for the Treatment of Chronic Venous Leg Ulcers
Summary   The main purpose of this study is to compare the effect of GrafixPL PRIME versus standard of care on healing of venous leg ulcers.
Description   Patients with venous leg ulcers will be observed in the study. Patients will randomly be placed in one of two arms: one will receive GrafixPL PRIME on their venous ulcer and one will receive standard of care. Patients may undergo weekly treatment for their wounds and can be treated with up to 12 applications of GrafixPL PRIME within the first 12 weeks. If the patient in the standard of care group has not healed by week 12, that patient can crossover into the GrafixPL PRIME group for 12 weeks.
IRB Number   1294795
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following: patients must be 18 years or older; have at least one wound that the treating physician determines may be treated with GrafixPL PRIME; willing and able to adhere to protocol requirements; agree to participate in the study program; and comply with the study follow-up regimen.
Status   Open
Start Date   09/01/2018
Principal Name   Scott Gorenstein, MD
Contact Name   Raelina Howell, MD
Email   Raelina.Howell@nyulangone.org
Fax   516-663-2690
Current Trial Type   Interventional
Phone   516-663-8498
Alternate Phone   516-663-1669