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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcer
• Intervention / Treatment: Device: AQUACEL®; Device: AQUACEL® Extra™

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wear Time	frequency of dressing changes	4 weeks
Wear Time	Reason for dressing changes	4 weeks
% of dressings achieving a 7 day wear time		4 weeks
Time to achieve a 7 day wear time		4 weeks
Condition of the peri-ulcer skin	Improvement from baseline in the condition of the peri-ulcer skin	4 weeks

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Principal Investigator: Keith G Harding, Cardiff University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 4, 2012

Study Record Updates

• Last Update Posted (Estimate): July 30, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: CW-0209-11-U361