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Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

NCT01591434 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2013-07-30

No results posted yet for this study

Summary

Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.

Conditions

  • Leg Ulcer

Interventions

DEVICE

AQUACEL®

Dressing to be changed as clinically needed or at least every seven days.

DEVICE

AQUACEL® Extra™

Dressing to be changed as clinically needed or at least every seven days.

Sponsors & Collaborators

  • ConvaTec Inc.

    lead INDUSTRY

Principal Investigators

  • Keith G Harding · Cardiff University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Germany
  • Netherlands
  • Poland
  • United Kingdom

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 NCT01591434 on ClinicalTrials.gov