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

March 17, 2022 updated by: Mylan Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angoulème, France, 16000
        • Research Facility ID ORG-001183
      • Annecy, France, 74000
        • Research Facility ID ORG-000857
      • Asnieres, France, 92600
        • Research facility ID ORG-000853
      • Beaune, France, 21200
        • Research facility ID ORG-000981
      • Boulogne sur Mer, France, 62200
        • Research Facility ID ORG-000844
      • Bourgoin Jallieu, France, 38300
        • Research Facility ID ORG-000869
      • Brest, France, 29609
        • Research facility ID ORG-001215
      • Figeac, France, 46100
        • Research Facility ID ORG-001181
      • Grenoble, France, 38043
        • Research facility ID ORG-001081
      • Hazebrouck, France, 59190
        • Research Facility ID ORG-000850
      • Lattes, France, 34970
        • Research facility ID ORG-000855
      • Laxou, France, 54520
        • Research Facility ID ORG-000859
      • Lyon, France, 69007
        • Research Facility ID ORG-000830
      • Melun, France, 77000
        • Research facility ORG-001362
      • Montpellier, France, 34000
        • Research Facility ID ORG-001182
      • Nancy, France, 54000
        • Research facility ID ORG-000836
      • Nantes, France, 44093
        • Research facility ORG-001361
      • Paris, France, 75019
        • Research facility ID ORG-000831
      • Paris, France, 75116
        • Research Facility ID ORG-000832
      • Pezenas, France, 34120
        • Research facility ID ORG-000856
      • Saint Aubin Sur Scie, France, 76550
        • Research facility ID ORG-001082
      • Saint Maur, France, 94100
        • Research facility ID ORG-000865
      • Tarare, France, 69170
        • Research facility ID ORG-000845
      • Toulon, France, 83800
        • Research facility ID ORG-001216
      • Toulouse, France, 31076
        • Research facility ID ORG-001083
      • Tours, France, 37000
        • Research Facility ID ORG-000862
      • Vincennes, France, 94300
        • Research facility ID ORG-000835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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);

Exclusion Criteria:

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: TulleGras M.S.
Device: TulleGras M.S.
Sterile dressing that consists of viscose tissue coated with mineral vaseline
Active Comparator: Urgotul
Device: Urgotul
sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mylan Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CEN Biotech

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Roger Lesaunier, MD, Mylan Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LINE4001
  • 2013-A01285-40 (Other Identifier: ANSM (French Health Agency) Registry number for biomedical research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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