Leg UlcerPhase 3NCT01591434
Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
A Phase 3 study testing AQUACEL® and AQUACEL® Extra™ in people with Leg Ulcer, run by ConvaTec Inc. at 12 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer
- What is being tested?
- AQUACEL® and AQUACEL® Extra™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 12 sitesin 4 countries
- Study dates
- May 2012to Sep 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United Kingdom5 sites
Bradford Teaching Hospitals
Bradford, BD9 6RJ
Wound Healing Research Unit, Cardiff University
Cardiff, CF14 4XN
Tissue Viability Consultancy Services Ltd
Eastbourne, BN21 4RL
Arrowe Park Hospital,
Upton, Wirral, CH49 5PE
Walsall Healthcare NHS Trust Short Heath Clinic
Willenhall, WV12 5PR
Poland4 sites
Nzoz Certus
Lodz, 90-553
CF Centrum Flebologii Anna i Beata Narojczyk
Warsaw, 03-983
Continuum Care
Warsaw, 18, 02-366
Medyczna "Medservice"
Zabrze, 41-819
Germany2 sites
Dermatologische Gemeinschaftspraxis
Freiburg im Breisgau, 79100
Bramfelder Chaussee
Hamburg
About this study
Official title: 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.
- Conditions
- Leg Ulcer
- Being tested
- AQUACEL®, AQUACEL® Extra™
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQUACEL®Device
Dressing to be changed as clinically needed or at least every seven days.
AQUACEL® Extra™Device
Dressing to be changed as clinically needed or at least every seven days.
| Study group | Role | What they receive |
|---|---|---|
| AQUACEL® | Active comparator | A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC). Receives: 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. Receives: Device: AQUACEL® Extra™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear Time
frequency of dressing changes
Measured: 4 weeks
Wear Time
Reason for dressing changes
Measured: 4 weeks
% of dressings achieving a 7 day wear time
Measured: 4 weeks
Time to achieve a 7 day wear time
Measured: 4 weeks
Condition of the peri-ulcer skin
Improvement from baseline in the condition of the peri-ulcer skin
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith G Harding, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591434
- Sponsor's protocol ID
- CW-0209-11-U361
- Status last verified
- Jul 2013
- First submitted
- 2 May 2012
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01591434
- Acronym / sponsor ID
- CW-0209-11-U361
- Conditions
- Leg Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AQUACEL® | Active comparator | Device: AQUACEL®A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC). |
| AQUACEL® Extra™ | Active comparator | Device: AQUACEL® Extra™A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQUACEL®Dressing to be changed as clinically needed or at least every seven days. | Device | AQUACEL® |
| AQUACEL® Extra™Dressing to be changed as clinically needed or at least every seven days. | Device | AQUACEL® Extra™ |
Primary outcome
Wear Time
Time frame: 4 weeks
frequency of dressing changes
Wear Time
Time frame: 4 weeks
Reason for dressing changes
% of dressings achieving a 7 day wear time
Time frame: 4 weeks
Time to achieve a 7 day wear time
Time frame: 4 weeks
Condition of the peri-ulcer skin
Time frame: 4 weeks
Improvement from baseline in the condition of the peri-ulcer skin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith G Harding principal investigator
Cardiff University
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AQUACEL® and AQUACEL® Extra™ in people with Leg Ulcer, run by ConvaTec Inc. at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Poland, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear Time (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.