Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485329
Status:
COMPLETED
Last Update Posted:
2010-05-25
First Post:
2007-06-10
Brief Title:
Assessment of the Safety and Efficacy of DERMASTREAM - ENZYSTREAM System for the Treatment of Chronic Venous Ulcers
Sponsor:
EnzySurge
Organization:
EnzySurge
Study Overview
Official Title:
A Phase III 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
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENZ-DER-002-IL
Brief Summary:
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
Detailed Description:
This is a phase III 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 15000 30000 and 60000 papain USP unitsml 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 41 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 15000 papain USP unitsml 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None