Varicose UlcerPhase 4NCT01449422
Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers.
A Phase 4 study testing Dressing in people with Varicose Ulcer, run by Laboratoires URGO at 1 site in France.
Trial summary
The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Jan 2013
- Phase
- Phase 4
- 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 duration of the study
- Patient who agrees to wear effective venous compression every day, associated with the trial dressing
- Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3
- Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2
- Ulcer duration between 3 and 36 months
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- Ulcer where the surface area is 70% or more covered by fibrinous tissue
- Ulcer at least 3 cm away from any other lesion
- Ulcer moderately or strongly exudative justifying the use of an absorbent dressing
Who cannot join
- Female patient of child-bearing potential who has no effective means of contraception
- Patient who is pregnant or breastfeeding
- Patient taking part in another therapeutic trial
- Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid)
- Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment
- Patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy
Show all 12Show fewer
- Patient with a systemic infection not controlled by suitable antibiotic treatment
- Patient who, during the 3 months before inclusion, presented a deep vein thrombosis
- Ulcer where its surface is totally or partially covered by black necrotic plaque
- Ulcer which is clinically infected
- Ulcer requiring surgical treatment or for which surgery is programmed during the six weeks following inclusion
- Malignant ulcer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of The Efficacy, Tolerance And Acceptability Of URGO Dressing 310 3082 Versus A Hydrofibre Dressing In The Local Management Of Venous Or Predominantly Venous Mixed Leg Ulcers
The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.
- Conditions
- Varicose Ulcer
- Being tested
- Dressing
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DressingDevice
the dressing should be changed on average every 1 to 2 days, then as often as required (up to 7 days) depending on the exudate volume and the clinical condition of the wound (evaluated by the investigating doctor).
DressingDevice
the hydrofibre dressing should be changed when it is saturated, or depending on the clinical appreciation of the situation. The dressing can remain in place for up to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| URGO 310 3082 | Experimental | Not described Receives: Device: Dressing |
| Aquacel | Active comparator | Not described Receives: Device: Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of dressings under trial will be judged on the evolution of wound surface area after six weeks of treatment.
The main evaluation criterion is the relative planimetric regression of the wound surface area, calculated according to the following formula, from centralised planimetric measurements:
Regression of the area (%) = [(ST0-STlast)/ST0] x 100 ST0: Surface area of the lesion measured on the day of inclusion STlast: Surface area of the lesion at the last planimetric evaluation available
Measured: Week 1, 2, 4 and 6
Secondary outcomes (10)
Comparison between the two devices of percentage of lesions in which the evolution is positive (defined by a relative regression at least 40% of wound surface) after monitoring for 6 weeks.
Measured: Week 1, 2, 4 and 6
Comparison between the two groups of percentage of debrided lesions (defined by a lesion with more than 70% of its surface covered by granulation tissue of a "red colour" on the colorimetric scale), at the last available evaluation
Measured: Week 1, 2, 4 and 6
Comparison between the two strategies of percentage of patients in whom at least one problem of pain was detected during care (VAS score at the end of care > 30 mm)
Measured: Week 1, 2, 4 and 6
Comparison between the 2 groups of the percentage of wound care associated with manual debridement
Measured: Week 1, 2, 4 and 6
Comparison between the two groups of the evolution of the patients' quality of life between inclusion and the last available visit. This quality of life will be assessed using the EuroQol-5D™ questionnaire
Measured: Week 1, 2, 4 and 6
Comparison between the 2 groups of the percentage of the participants number with Adverse Events
Measured: Week 1, 2, 4 and 6
Comparison between the 2 groups of the mean number of dressing changes per week.
Measured: Week 1, 2, 4 and 6
Comparison between the 2 groups of the easiness application and removal
Measured: Week 1, 2, 4 and 6
Comparison between the 2 groups of the percentage of good or very good conformability
Measured: Week 1, 2, 4 and 6
Comparison between the 2 groups of the mean value for overall performance score
This score will be between 0 and 36
Measured: Week 1, 2, 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449422
- Sponsor's protocol ID
- FI-11-02-310 3082
- Status last verified
- Mar 2013
- First submitted
- 3 Oct 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Efficacy, Tolerance And Acceptability Of URGO Dressing 310 3082 Versus A Hydrofibre Dressing In The Local Management Of Venous Or Predominantly Venous Mixed Leg Ulcers
- ClinicalTrials.gov ID
- NCT01449422
- Acronym / sponsor ID
- FI-11-02-310 3082
- Conditions
- Varicose Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- First posted
- 10 Oct 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 main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| URGO 310 3082 | Experimental | Device: Dressing |
| Aquacel | Active comparator | Device: Dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 duration of the study
- Patient who agrees to wear effective venous compression every day, associated with the trial dressing
- Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3
- Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2
Key exclusion criteria (12 listed)
- Female patient of child-bearing potential who has no effective means of contraception
- Patient who is pregnant or breastfeeding
- Patient taking part in another therapeutic trial
- Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid)
- Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment
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 |
|---|---|---|
| Dressingthe dressing should be changed on average every 1 to 2 days, then as often as required (up to 7 days) depending on the exudate volume and the clinical condition of the wound (evaluated by the investigating doctor). | Device | URGO 310 3082 |
| Dressingthe hydrofibre dressing should be changed when it is saturated, or depending on the clinical appreciation of the situation. The dressing can remain in place for up to 7 days. | Device | Aquacel |
Primary outcome
The efficacy of dressings under trial will be judged on the evolution of wound surface area after six weeks of treatment.
Time frame: Week 1, 2, 4 and 6
The main evaluation criterion is the relative planimetric regression of the wound surface area, calculated according to the following formula, from centralised planimetric measurements: Regression of the area (%) = [(ST0-STlast)/ST0] x 100 ST0: Surface area of the lesion measured on the day of inclusion STlast: Surface area of the lesion at the last planimetric evaluation available
10 secondary outcomes
Comparison between the two devices of percentage of lesions in which the evolution is positive (defined by a relative regression at least 40% of wound surface) after monitoring for 6 weeks.
Time frame: Week 1, 2, 4 and 6
Comparison between the two groups of percentage of debrided lesions (defined by a lesion with more than 70% of its surface covered by granulation tissue of a "red colour" on the colorimetric scale), at the last available evaluation
Time frame: Week 1, 2, 4 and 6
Comparison between the two strategies of percentage of patients in whom at least one problem of pain was detected during care (VAS score at the end of care > 30 mm)
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the percentage of wound care associated with manual debridement
Time frame: Week 1, 2, 4 and 6
Comparison between the two groups of the evolution of the patients' quality of life between inclusion and the last available visit. This quality of life will be assessed using the EuroQol-5D™ questionnaire
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the percentage of the participants number with Adverse Events
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the mean number of dressing changes per week.
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the easiness application and removal
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the percentage of good or very good conformability
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the mean value for overall performance score
Time frame: Week 1, 2, 4 and 6
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 29 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dressing in people with Varicose Ulcer, 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 9 inclusion and 12 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 29 Mar 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The efficacy of dressings under trial will be judged on the evolution of wound surface area after six weeks of treatment. (time frame: Week 1, 2, 4 and 6). 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 29 Mar 2013.