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

Primary Purpose

Leg Ulcer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AQUACEL®
AQUACEL® Extra™
Sponsored by
ConvaTec Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dermatologische Gemeinschaftspraxis
  • Bramfelder Chaussee
  • Mitralis Expertise Centrum
  • Continuum Care
  • CF Centrum Flebologii Anna i Beata Narojczyk
  • Medyczna "Medservice"
  • Nzoz Certus
  • Arrowe Park Hospital,
  • Bradford Teaching Hospitals
  • Wound Healing Research Unit, Cardiff University
  • Tissue Viability Consultancy Services Ltd
  • Walsall Healthcare NHS Trust Short Heath Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AQUACEL®

AQUACEL® Extra™

Arm Description

A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC).

A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 2, 2012
Last Updated
July 29, 2013
Sponsor
ConvaTec Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01591434
Brief Title
Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
Official Title
An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConvaTec Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AQUACEL®
Arm Type
Active Comparator
Arm Description
A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC).
Arm Title
AQUACEL® Extra™
Arm Type
Active Comparator
Arm Description
A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns.
Intervention Type
Device
Intervention Name(s)
AQUACEL®
Intervention Description
Dressing to be changed as clinically needed or at least every seven days.
Intervention Type
Device
Intervention Name(s)
AQUACEL® Extra™
Intervention Description
Dressing to be changed as clinically needed or at least every seven days.
Primary Outcome Measure Information:
Title
Wear Time
Description
frequency of dressing changes
Time Frame
4 weeks
Title
Wear Time
Description
Reason for dressing changes
Time Frame
4 weeks
Title
% of dressings achieving a 7 day wear time
Time Frame
4 weeks
Title
Time to achieve a 7 day wear time
Time Frame
4 weeks
Title
Condition of the peri-ulcer skin
Description
Improvement from baseline in the condition of the peri-ulcer skin
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith G Harding
Organizational Affiliation
Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatologische Gemeinschaftspraxis
City
Freiburg
ZIP/Postal Code
79100
Country
Germany
Facility Name
Bramfelder Chaussee
City
Hamburg
Country
Germany
Facility Name
Mitralis Expertise Centrum
City
Heerlen
ZIP/Postal Code
6401 CX
Country
Netherlands
Facility Name
Continuum Care
City
Warsaw
ZIP/Postal Code
18, 02-366
Country
Poland
Facility Name
CF Centrum Flebologii Anna i Beata Narojczyk
City
Warszawa
ZIP/Postal Code
03-983
Country
Poland
Facility Name
Medyczna "Medservice"
City
Zabrze
ZIP/Postal Code
41-819
Country
Poland
Facility Name
Nzoz Certus
City
Łódź
ZIP/Postal Code
90-553
Country
Poland
Facility Name
Arrowe Park Hospital,
City
Upton
State/Province
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
Facility Name
Bradford Teaching Hospitals
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Wound Healing Research Unit, Cardiff University
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Tissue Viability Consultancy Services Ltd
City
Eastbourne
ZIP/Postal Code
BN21 4RL
Country
United Kingdom
Facility Name
Walsall Healthcare NHS Trust Short Heath Clinic
City
Willenhall
ZIP/Postal Code
WV12 5PR
Country
United Kingdom

12. IPD Sharing Statement

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

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