Venous Leg UlcerNCT02104180
Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras
A study testing Urgotul and TulleGras M.S. in people with Venous Leg Ulcer, run by Mylan Inc. at 27 sites in France.
Trial summary
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Urgotul and TulleGras M.S.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 27 sitesFrance
- Study dates
- Feb 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject informed of the objectives, purpose, details and constraints of the study and who has given his/her written informed consent.
- Male or female subject.
- Subject at least 45 years of age.
- Subject presenting with an open venous leg ulcer.
- Age of venous leg ulcer between 1 month and 12 months inclusive at the Inclusion Visit (Visit 1).
- Venous leg ulcer whose area is between 4 cm2 and 50 cm2 inclusive at the Inclusion Visit (Visit 1).
- Venous leg ulcer in the granulation phase over 50% of its area at the Inclusion Visit (Visit 1);
Who cannot join
- Related to the disease studied:
- Venous leg ulcer for which surgery is indicated or for which a surgical procedure is planned within twelve weeks of inclusion in the study (Visit 1).
- Venous leg ulcer at start of cleaning phase;
- Fibrinous and dry ulcer (non exudative wound) or on the contrary highly exudative and/or hemorrhagic.
- Venous leg ulcer with signs of critical colonization or clinically infected.
- Cancerous venous leg ulcer.
Show all 24Show fewer
- Related to the subject:
- Subject presenting with a serious systemic disease, which may lead to premature termination of the study before the end of the twelve weeks of treatment of the Follow up Period.
- Subject with a medical history or a significant disease revealed by history which can limit his/her participation or prevent the subject from completing the study.
- Subject presenting with a progressive neoplasm, treated with radiotherapy or chemotherapy or immunosuppressant therapy or high-dose corticosteroids.
- Subject who underwent surgery directly related to his/her venous disease during the two months prior to Inclusion Visit (Visit 1).
- Subject with poorly controlled diabetes.
- Subject who presented with a deep venous thrombosis during the 3 months prior to Inclusion Visit (Visit 1).
- Subject confined to bed.
- Woman of child-bearing potential (NOT postmenopausal for at least 24 months or NOT surgically sterilized (tubal ligation) or NOT hysterectomized) who is NOT routinely using adequate and efficient hormonal contraception or barrier method (intrauterine device, diaphragm, combination of condom and spermicide) prior to and during the trial.
- Subject whose ankle has a circumference, measured at the Inclusion Visit (Visit 1), greater than 32 cm (> 32 cm).
- Subject presenting with symptomatic or asymptomatic peripheral arterial disease, particularly with a distal systolic pressure index, measured at the Inclusion Visit (Visit 1), ≤0.8 or ≥1.3.
- Subject with a history of allergic reaction(s) to one of the different components of the dressings or with a contra-indication to the use of one of these dressings.
- Known history of alcohol abuse or drug abuse.
- Subject linguistically or psychologically unable to understand the information given and to provide informed consent.
- Subject participating in or who participated in another clinical study within 4 weeks prior to the Inclusion Visit (Visit 1).
- Subject not covered by or not a beneficiary of the Social Security system.
- Subject deprived of his freedom as the result of a legal or administrative decision or subject to legal guardianship.
- Any other reason, in the investigator's opinion, that prohibits the inclusion of the subject into the study.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
Research Facility ID ORG-001183
Angoulème, 16000
Research Facility ID ORG-000857
Annecy, 74000
Research facility ID ORG-000853
Asnières, 92600
Research facility ID ORG-000981
Beaune, 21200
Research Facility ID ORG-000844
Boulogne-sur-Mer, 62200
Research Facility ID ORG-000869
Bourgoin, 38300
Research facility ID ORG-001215
Brest, 29609
Research Facility ID ORG-001181
Figeac, 46100
Research facility ID ORG-001081
Grenoble, 38043
Research Facility ID ORG-000850
Hazebrouck, 59190
Research facility ID ORG-000855
Lattes, 34970
Research Facility ID ORG-000859
Laxou, 54520
Research Facility ID ORG-000830
Lyon, 69007
Research facility ORG-001362
Melun, 77000
Research Facility ID ORG-001182
Montpellier, 34000
Research facility ID ORG-000836
Nancy, 54000
Research facility ORG-001361
Nantes, 44093
Research facility ID ORG-000831
Paris, 75019
Research Facility ID ORG-000832
Paris, 75116
Research facility ID ORG-000856
Pézenas, 34120
Research facility ID ORG-001082
Saint-Aubin-sur-Scie, 76550
Research facility ID ORG-000865
Saint-Maur, 94100
Research facility ID ORG-000845
Tarare, 69170
Research facility ID ORG-001216
Toulon, 83800
Research facility ID ORG-001083
Toulouse, 31076
Research Facility ID ORG-000862
Tours, 37000
Research facility ID ORG-000835
Vincennes, 94300
About this study
Official title: Evaluation of the Non-inferiority of TulleGras M.S.® Versus Urgotul® in Pain Associated With Removal of Wound Dressing During Care of Venous Leg Ulcer. An Open-label, Multicenter, Randomized, Controlled, Crossover Study With Blinded Reading of Healing Criteria.
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
- Conditions
- Venous Leg Ulcer
- Being tested
- Urgotul, TulleGras M.S.
- Keywords
- non-inferiority, randomized, TulleGras, Urgotul, pain, venous leg ulcer, healing
- Medical subject headings
- Varicose Ulcer, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrgotulDevice
sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline
TulleGras M.S.Device
Sterile dressing that consists of viscose tissue coated with mineral vaseline
| Study group | Role | What they receive |
|---|---|---|
| TulleGras M.S. | Active comparator | Not described Receives: Device: TulleGras M.S. |
| Urgotul | Active comparator | Not described Receives: Device: Urgotul |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal
Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating " no pain " (0) and " extreme pain " (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing.
Measured: at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEN Biotech
- Responsible party
- Sponsor
- Investigators
- Roger Lesaunier, MD, Study director, Mylan Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104180
- Sponsor's protocol ID
- LINE4001
- Other IDs
- 2013-A01285-40
- Status last verified
- Mar 2017
- First submitted
- 27 Feb 2014
- Last updated
- 21 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Non-inferiority of TulleGras M.S.® Versus Urgotul® in Pain Associated With Removal of Wound Dressing During Care of Venous Leg Ulcer. An Open-label, Multicenter, Randomized, Controlled, Crossover Study With Blinded Reading of Healing Criteria.
- ClinicalTrials.gov ID
- NCT02104180
- Acronym / sponsor ID
- LINE4001
- Conditions
- Venous Leg Ulcer
- Keywords
- non-inferiority, randomized, TulleGras, Urgotul, pain, venous leg ulcer, healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- CEN Biotech
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TulleGras M.S. | Active comparator | Device: TulleGras M.S. |
| Urgotul | Active comparator | Device: Urgotul |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject informed of the objectives, purpose, details and constraints of the study and who has given his/her written informed consent.
- Male or female subject.
- Subject at least 45 years of age.
- Subject presenting with an open venous leg ulcer.
- Age of venous leg ulcer between 1 month and 12 months inclusive at the Inclusion Visit (Visit 1).
Key exclusion criteria (24 listed)
- Venous leg ulcer for which surgery is indicated or for which a surgical procedure is planned within twelve weeks of inclusion in the study (Visit 1).
- Venous leg ulcer at start of cleaning phase;
- Fibrinous and dry ulcer (non exudative wound) or on the contrary highly exudative and/or hemorrhagic.
- Venous leg ulcer with signs of critical colonization or clinically infected.
- Cancerous venous leg ulcer.
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 |
|---|---|---|
| Urgotulsterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline | Device | Urgotul |
| TulleGras M.S.Sterile dressing that consists of viscose tissue coated with mineral vaseline | Device | TulleGras M.S. |
Primary outcome
Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal
Time frame: at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)
Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating " no pain " (0) and " extreme pain " (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roger Lesaunier, MD study director
Mylan Inc.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urgotul and TulleGras M.S. in people with Venous Leg Ulcer, run by Mylan Inc. at 27 sites 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 7 inclusion and 24 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 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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?
Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal (time frame: at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)). 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 21 Mar 2022.