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

Phase 3

Completed

• Conditions: Leg Ulcer
• Interventions: Device: AQUACEL®; Device: AQUACEL® Extra™

• Registration Number: NCT01591434
• Lead Sponsor: ConvaTec Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AQUACEL®	AQUACEL®	A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC).
AQUACEL® Extra™	AQUACEL® Extra™	A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns.

Primary Outcome Measures

Name	Time	Method
Wear Time	4 weeks	Reason for dressing changes
% 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	4 weeks	Improvement from baseline in the condition of the peri-ulcer skin

Trial Locations

Locations (12)

Dermatologische Gemeinschaftspraxis; 🇩🇪 Freiburg, Germany

Bramfelder Chaussee; 🇩🇪 Hamburg, Germany

Mitralis Expertise Centrum; 🇳🇱 Heerlen, Netherlands

Wound Healing Research Unit, Cardiff University; 🇬🇧 Cardiff, United Kingdom

Walsall Healthcare NHS Trust Short Heath Clinic; 🇬🇧 Willenhall, United Kingdom

Bradford Teaching Hospitals; 🇬🇧 Bradford, United Kingdom

Continuum Care; 🇵🇱 Warsaw, Poland

CF Centrum Flebologii Anna i Beata Narojczyk; 🇵🇱 Warszawa, Poland

Medyczna "Medservice"; 🇵🇱 Zabrze, Poland

Tissue Viability Consultancy Services Ltd; 🇬🇧 Eastbourne, United Kingdom

Nzoz Certus; 🇵🇱 Łódź, Poland

Arrowe Park Hospital,; 🇬🇧 Upton, Wirral, United Kingdom