NCT01591434

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Shorter than P25 for phase_3

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

May 2, 2012

Last Update Submit

July 29, 2013

Conditions

Leg Ulcer

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

AQUACEL®

ACTIVE COMPARATOR

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

Device: AQUACEL®

AQUACEL® Extra™

ACTIVE COMPARATOR

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

Device: AQUACEL® Extra™

Interventions

AQUACEL®DEVICE

Dressing to be changed as clinically needed or at least every seven days.

AQUACEL®
AQUACEL® Extra™DEVICE

Dressing to be changed as clinically needed or at least every seven days.

AQUACEL® Extra™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 who have participated in a clinical study within the past month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Dermatologische Gemeinschaftspraxis

Freiburg im Breisgau, 79100, Germany

Location

Bramfelder Chaussee

Hamburg, Germany

Location

Mitralis Expertise Centrum

Heerlen, 6401 CX, Netherlands

Location

Nzoz Certus

Lodz, 90-553, Poland

Location

CF Centrum Flebologii Anna i Beata Narojczyk

Warsaw, 03-983, Poland

Location

Continuum Care

Warsaw, 18, 02-366, Poland

Location

Medyczna "Medservice"

Zabrze, 41-819, Poland

Location

Arrowe Park Hospital,

Upton, Wirral, CH49 5PE, United Kingdom

Location

Bradford Teaching Hospitals

Bradford, BD9 6RJ, United Kingdom

Location

Wound Healing Research Unit, Cardiff University

Cardiff, CF14 4XN, United Kingdom

Location

Tissue Viability Consultancy Services Ltd

Eastbourne, BN21 4RL, United Kingdom

Location

Walsall Healthcare NHS Trust Short Heath Clinic

Willenhall, WV12 5PR, United Kingdom

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Keith G Harding

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 4, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

NL(1)DE(2)GB(5)PL(4)