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Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers

NCT00521027 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-02-19

No results posted yet for this study

Summary

The purpose of this study is to compare the VERSAJET™ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers.

It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the VERSAJET™ device than with conventional surgical procedures.

Conditions

  • Diabetic Foot
  • Varicose Ulcer
  • Pressure Ulcer

Interventions

DEVICE

Versajet Hydrosurgery System

Debridement with Versajet Hydrosurgery System

PROCEDURE

Conventional surgical debridement techniques

Conventional surgical debridement with scalpel and pulse lavage

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Wayne J Caputo, DPM · Clara Maass Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Completion
2006-09-30

Countries

  • United States

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 NCT00521027 on ClinicalTrials.gov