Lower Extremity Chronic Venous Ulcers Clinical Trial
Official title:
A Phase I/II Randomized, Double Blind, Placebo-Controlled Dose- Escalating Study, to Assess The Safety and Efficacy of Enzystream™ Debriding Solution (Papain) Applied by Dermastream™ Device for the Treatment of Lower Extremity Chronic Venous Ulcers
The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous ulcers patients.
This is a phase I/II prospective, randomized, double blind, placebo controlled, dose
escalating, three patient-group study, to evaluate the safety and efficacy of DermaStream™ -
EnzyStream™ System in non-healing lower extremity chronic venous ulcers patients. The
DermaStream™ - EnzyStream™ System will be evaluated during continues streaming of 3
different doses of EnzystreamTM (papain based) solution given in an escalating order
(15,000, 30,000 and 60,000 papain USP units/ml) up to 5 consecutive treatment days. Each
treatment session lasts for 6 hours. This study is a Multi center trial. It is anticipated
that three (3) sites will enroll subjects into this study. Overall, forty eight (48)
patients will be recruited, and randomly allocated to placebo or EnzyStream™ treatment in
each study dose group prior to EnzyStream™ administration. The ratio of drug to placebo
treated patients will be 4;1, namely 12 patients will be administered with EnzyStream™
solution and 4 patients will be placebo treated in each of the three respective EnzyStream™
dose groups. Treatment will start with the lowest dose (15,000 papain USP units/ml)
administered over a 6 hour period followed with saline wash for an additional half an hour.
The treatment dose will be increased to the next highest dose, for the next patients group
only following safety analysis, and the procedure will be repeated.
The treatment period will be followed by a 3 month follow up period. During the follow up
period patients will be observed for every 2 weeks during the first month and once a month
(every 20 days) during the 2 additional months (allowing a time window of ± 3 days).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment