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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01591434
First received: May 2, 2012
Last updated: July 29, 2013
Last verified: July 2013

May 2, 2012
July 29, 2013
May 2012
September 2012   (final data collection date for primary outcome measure)
  • Wear Time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    frequency of dressing changes
  • Wear Time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Reason for dressing changes
  • % of dressings achieving a 7 day wear time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Time to achieve a 7 day wear time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Condition of the peri-ulcer skin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement from baseline in the condition of the peri-ulcer skin
Same as current
Complete list of historical versions of study NCT01591434 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Leg Ulcer
  • 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.
  • Active Comparator: AQUACEL®
    A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC).
    Intervention: Device: AQUACEL®
  • Active Comparator: AQUACEL® Extra™
    A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns.
    Intervention: Device: AQUACEL® Extra™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects over 18 years, willing and able to provide written informed consent.
  • Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater
  • Subjects who have a venous leg ulcer (i.e. CEAP classification of C6 1) with duration less than 24 months
  • Subjects whose ulcer is no smaller than 2cms in any one direction
  • Subjects whose ulcer is no greater than 11cm in any one direction (measured by longest length and widest width)
  • Subjects' whose index leg ulcer has a moderate to heavy level of exudate.
  • Subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control
  • Subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required.

Exclusion Criteria:

  • Subjects with a history of skin sensitivity to any of the components of the study dressings (AQUACEL® Extra™, AQUACEL®, & DuoDERM™ Extra Thin)
  • Subjects whose wounds are considered clinically infected at baseline
  • Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
  • Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents
  • Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
  • Subjects who have participated in a clinical study within the past month.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands,   Poland,   United Kingdom
 
NCT01591434
CW-0209-11-U361
No
ConvaTec Inc.
ConvaTec Inc.
Not Provided
Principal Investigator: Keith G Harding Cardiff University
ConvaTec Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP