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
NCT ID: NCT02104180
Last Updated: 2022-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2014-02-28
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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TulleGras M.S.
TulleGras M.S.
Sterile dressing that consists of viscose tissue coated with mineral vaseline
Urgotul
Urgotul
sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline
Interventions
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Urgotul
sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline
TulleGras M.S.
Sterile dressing that consists of viscose tissue coated with mineral vaseline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
ALL
No
Sponsors
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CEN Biotech
INDUSTRY
Mylan Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Roger Lesaunier, MD
Role: STUDY_DIRECTOR
Mylan Inc.
Locations
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Research Facility ID ORG-001183
Angoulème, , France
Research Facility ID ORG-000857
Annecy, , France
Research facility ID ORG-000853
Asnières, , France
Research facility ID ORG-000981
Beaune, , France
Research Facility ID ORG-000844
Boulogne-sur-Mer, , France
Research Facility ID ORG-000869
Bourgoin, , France
Research facility ID ORG-001215
Brest, , France
Research Facility ID ORG-001181
Figeac, , France
Research facility ID ORG-001081
Grenoble, , France
Research Facility ID ORG-000850
Hazebrouck, , France
Research facility ID ORG-000855
Lattes, , France
Research Facility ID ORG-000859
Laxou, , France
Research Facility ID ORG-000830
Lyon, , France
Research facility ORG-001362
Melun, , France
Research Facility ID ORG-001182
Montpellier, , France
Research facility ID ORG-000836
Nancy, , France
Research facility ORG-001361
Nantes, , France
Research facility ID ORG-000831
Paris, , France
Research Facility ID ORG-000832
Paris, , France
Research facility ID ORG-000856
Pézenas, , France
Research facility ID ORG-001082
Saint-Aubin-sur-Scie, , France
Research facility ID ORG-000865
Saint-Maur, , France
Research facility ID ORG-000845
Tarare, , France
Research facility ID ORG-001216
Toulon, , France
Research facility ID ORG-001083
Toulouse, , France
Research Facility ID ORG-000862
Tours, , France
Research facility ID ORG-000835
Vincennes, , France
Countries
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Other Identifiers
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2013-A01285-40
Identifier Type: OTHER
Identifier Source: secondary_id
LINE4001
Identifier Type: -
Identifier Source: org_study_id
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