Leg UlcerPhase 2NCT01497210
EASH Dressing on Chronic Venous Leg Ulcers
A Phase 2 study testing EASH dressing in people with Leg Ulcer, run by ConvaTec Inc. at 6 sites in 2 countries.
Trial summary
The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on 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?
- EASH dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Nov 2011to Apr 2012
- Phase
- Phase 2
- 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 and size ranging between 5 cm2-40 cm2.
- Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs of infection: pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour (foul odour), and heavy exudate.
- Subjects who agree to wear compression therapy daily in combination with the trial dressing.
Who cannot join
- Subjects with a history of skin sensitivity to any of the components of the study product.
- Subjects who have had current local or systemic antibiotics in the week prior to inclusion with the exception of wounds that are considered to be 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
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom3 sites
Axbridge & Wedmore Medical Practice
Axbridge, Somerset, BS26 2BJ
Wound Healing Research Unit
Heathpark, Cardiff, CF14 4XN
Arrowe Park Hospital
Upton, Wirral, CH49 5PE
About this study
Official title: A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the EASH Dressing on Chronic Venous Leg Ulcers
The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.
- Conditions
- Leg Ulcer
- Being tested
- EASH dressing
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EASH dressingDevice
Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| EASH | Experimental | Not described Receives: Device: EASH dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Nature and frequency of adverse events.
Measured: All 8 weeks
Secondary outcomes (8)
Ulcer Improvement (wound bed)
Measured: Baseline, week 4 and week 8
Ulcer Improvement (peri-ulcer)
Measured: Baseline, week 4 and week 8 or final visit
Healing
Reduction in ulcer area
Measured: Weekly for 4 weeks then biweekly for 4 weeks or final visit
Healing
Number of subjects healed
Measured: 8 weeks or final visit
Healing
Time to healing
Measured: 8 weeks or final visit
Ulcer pain
Measured: Weekly for 4 weeks then biweekly for 4 weeks or final visit
Comfort
Measured: Weekly for 4 weeks then biweekly for 4 weeks
Ease of use
Measured: Weekly for 4 weeks then biweekly for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionApr 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Harding, Principal investigator, Wound Healing Research Unit, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497210
- Sponsor's protocol ID
- CW-0205-11-U356
- Status last verified
- Apr 2012
- First submitted
- 20 Dec 2011
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the EASH Dressing on Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT01497210
- Acronym / sponsor ID
- CW-0205-11-U356
- Conditions
- Leg Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Dec 2011 (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.
The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EASH | Experimental | Device: EASH dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 and size ranging between 5 cm2-40 cm2.
- Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs of infection: pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour (foul odour), and heavy exudate.
- Subjects who agree to wear compression therapy daily in combination with the trial dressing.
Key exclusion criteria (6 listed)
- Subjects with a history of skin sensitivity to any of the components of the study product.
- Subjects who have had current local or systemic antibiotics in the week prior to inclusion with the exception of wounds that are considered to be 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 |
|---|---|---|
| EASH dressingApply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks. | Device | EASH |
Primary outcome
Safety
Time frame: All 8 weeks
Nature and frequency of adverse events.
8 secondary outcomes
Ulcer Improvement (wound bed)
Time frame: Baseline, week 4 and week 8
Ulcer Improvement (peri-ulcer)
Time frame: Baseline, week 4 and week 8 or final visit
Healing
Time frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit
Healing
Time frame: 8 weeks or final visit
Healing
Time frame: 8 weeks or final visit
Ulcer pain
Time frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit
Comfort
Time frame: Weekly for 4 weeks then biweekly for 4 weeks
Ease of use
Time frame: Weekly for 4 weeks then biweekly for 4 weeks
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 25 Apr 2012.
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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 Harding principal investigator
Wound Healing Research Unit, Cardiff University
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EASH dressing in people with Leg Ulcer, run by ConvaTec Inc. at 6 sites in 2 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 5 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 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety (time frame: All 8 weeks). 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 25 Apr 2012.