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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

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ClinicalTrials.gov Identifier: NCT02104180
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
CEN Biotech
Information provided by (Responsible Party):
Mylan Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Device: Urgotul Device: TulleGras M.S. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : February 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104180


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

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Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02104180     History of Changes
Other Study ID Numbers: LINE4001
2013-A01285-40 ( Other Identifier: ANSM (French Health Agency) Registry number for biomedical research )
First Posted: April 4, 2014    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019
Last Verified: March 2017
Keywords provided by Mylan Inc.:
non-inferiority
randomized
TulleGras
Urgotul
pain
venous leg ulcer
healing
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases