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Clinical Trials

Topic   Pressure Ulcers
Title   A Prospective, Multicenter, Randomized, Controlled Clinical Study Of PuraPly™ AM and Standard of Care (SOC) compared to SOC alone For The Management Of Stage II-IV Pressure Ulcers
Summary   The main purpose of this study is to compare the effect of PuraPly AM versus standard of care on healing of stage II-IV pressure ulcers.
Description   Patients with stage II through IV pressure ulcers will be observed in the study. Patients will randomly be placed in one of two arms: one will receive PuraPly AM on their pressure ulcer and one will receive standard of care. Patients may undergo weekly treatment for their wounds and can be treated with up to 10 applications of PuraPly AM 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 PuraPly AM group for 12 weeks.
IRB Number   1130987
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 PuraPly AM; 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   05/09/2018
Principal Name   Scott Gorenstein, MD
Contact Name   Jon Woods, MD
Email   Jon.Woods@nyulangone.org
Fax   516-663-2690
Current Trial Type   Interventional
Phone   516-663-8498
Alternate Phone   516-663-4926