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
  Purpose

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.


Condition Intervention Phase
Leg Ulcer
Device: AQUACEL®
Device: AQUACEL® Extra™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • 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


Enrollment: 65
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AQUACEL®
A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC).
Device: AQUACEL®
Dressing to be changed as clinically needed or at least every seven days.
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.
Device: AQUACEL® Extra™
Dressing to be changed as clinically needed or at least every seven days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591434

Locations
Germany
Dermatologische Gemeinschaftspraxis
Freiburg, Germany, 79100
Bramfelder Chaussee
Hamburg, Germany
Netherlands
Mitralis Expertise Centrum
Heerlen, Netherlands, 6401 CX
Poland
Continuum Care
Warsaw, Poland, 18, 02-366
CF Centrum Flebologii Anna i Beata Narojczyk
Warszawa, Poland, 03-983
Medyczna "Medservice"
Zabrze, Poland, 41-819
Nzoz Certus
Łódź, Poland, 90-553
United Kingdom
Arrowe Park Hospital,
Upton, Wirral, United Kingdom, CH49 5PE
Bradford Teaching Hospitals
Bradford, United Kingdom, BD9 6RJ
Wound Healing Research Unit, Cardiff University
Cardiff, United Kingdom, CF14 4XN
Tissue Viability Consultancy Services Ltd
Eastbourne, United Kingdom, BN21 4RL
Walsall Healthcare NHS Trust Short Heath Clinic
Willenhall, United Kingdom, WV12 5PR
Sponsors and Collaborators
ConvaTec Inc.
Investigators
Principal Investigator: Keith G Harding Cardiff University
  More Information

No publications provided

Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01591434     History of Changes
Other Study ID Numbers: CW-0209-11-U361
Study First Received: May 2, 2012
Last Updated: July 29, 2013
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Leg Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014