Leg UlcersNCT02583958
Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers
A study testing Urgo 3103166 and Aquacel Extra in people with Leg Ulcers, run by Laboratoires URGO at 1 site in France.
Trial summary
Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcers
- What is being tested?
- Urgo 3103166 and Aquacel Extra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Jun 2017
- Phase
- Interventional
- 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
- Patient over 18 years old who has provided his/her written informed consent,
- Patient who can be monitored by the same investigation team throughout the whole duration of the study,
- Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,
- Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,
- Ulcer area > or equal to 5cm2,
- Ulcer duration > or equal to 6 months,
- Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,
- Moderately or heavily exudative ulcers.
Who cannot join
- Clinical infection on the wound bed.
Trial locations and contacts
1 site in 1 country.
Sylvie Meaume, MD contact
France1 site, 1 recruiting
- Recruiting
Hospital Rothschild
Paris, 75012
Sylvie Meaume, MD
About this study
Official title: Assessment of Efficacy and Safety for a New Wound Dressing URGO 310 3166 in the Local Treatment of Venous or Mixed Leg Ulcers: A European, Randomised Clinical Trial
Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.
- Conditions
- Leg Ulcers
- Being tested
- Urgo 3103166, 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.
Urgo 3103166Device
URGO 310 3166 dressing should be changed as often as required (let to the Investigator's convenience). The dressing change frequency is based on the exudate level and the clinical progress of the wound (up to 7 days).
Aquacel ExtraDevice
Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Device Urgo 3103166 | Experimental | Soft-adherent hydro-desloughing dressing Receives: Device: Urgo 3103166 |
| Device Aquacel Extra | Active comparator | Hydrofibre dressing Receives: Device: Aquacel Extra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative regression of wound surface area
Measured: week 20
Secondary outcomes (3)
Percentage of debrided wounds
Measured: at each clinical evaluation up to 20 weeks
Occurrence of adverse events as assessed by the investigator according to a classification MedDRA
Measured: between inclusion and week 20
Patient's Quality of Life
Measured: at inclusion visit and at week 20 or at the end of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2014
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sylvie Meaume, MD, Principal investigator, Hospital Rothschild - Paris - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583958
- Sponsor's protocol ID
- FI-14-06-310 3166
- Status last verified
- Oct 2015
- First submitted
- 12 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy and Safety for a New Wound Dressing URGO 310 3166 in the Local Treatment of Venous or Mixed Leg Ulcers: A European, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02583958
- Acronym / sponsor ID
- FI-14-06-310 3166
- Conditions
- Leg Ulcers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 22 Oct 2015 (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.
Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Urgo 3103166 | Experimental | Device: Urgo 3103166Soft-adherent hydro-desloughing dressing |
| Device Aquacel Extra | Active comparator | Device: Aquacel ExtraHydrofibre dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient over 18 years old who has provided his/her written informed consent,
- Patient who can be monitored by the same investigation team throughout the whole duration of the study,
- Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,
- Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,
- Ulcer area > or equal to 5cm2,
Key exclusion criteria (1 listed)
- Clinical infection on the wound bed.
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 |
|---|---|---|
| Urgo 3103166URGO 310 3166 dressing should be changed as often as required (let to the Investigator's convenience). The dressing change frequency is based on the exudate level and the clinical progress of the wound (up to 7 days). | Device | Device Urgo 3103166 |
| Aquacel ExtraAquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated. | Device | Device Aquacel Extra |
Primary outcome
Relative regression of wound surface area
Time frame: week 20
3 secondary outcomes
Percentage of debrided wounds
Time frame: at each clinical evaluation up to 20 weeks
Occurrence of adverse events as assessed by the investigator according to a classification MedDRA
Time frame: between inclusion and week 20
Patient's Quality of Life
Time frame: at inclusion visit and at week 20 or at the end of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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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.
Sylvie Meaume, MD contact
Sylvie Meaume, MD principal investigator
Hospital Rothschild - Paris - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urgo 3103166 and Aquacel Extra in people with Leg Ulcers, run by Laboratoires URGO at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Meaume, MD (sylvie.meaume@rth.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative regression of wound surface area (time frame: week 20). 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 22 Oct 2015.