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Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers

NCT00485329 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2010-05-25

No results posted yet for this study

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.

Conditions

  • Lower Extremity Chronic Venous Ulcers

Interventions

OTHER

Papain

15,000 USP U/ml

OTHER

Papain

30,000 USP U/ml

OTHER

Papain

60,000 USP U/ml

Sponsors & Collaborators

  • EnzySurge

    lead INDUSTRY

Principal Investigators

  • Arie Bass, Prof. · Assaf Harofe Medical Center

  • Sami Nitezki, Dr. · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00485329 on ClinicalTrials.gov