Clinical trial NCT02104180: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: non-inferiority
randomized
TulleGras
Urgotul
pain
venous leg ulcer
healing
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: CEN Biotech
First posted: 2014-04-04
Enrollment: 62
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal
timeFrame: at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Angoulème
country: France
facility: Research Facility ID ORG-001183
city: Annecy
country: France
facility: Research Facility ID ORG-000857
city: Asnieres
country: France
facility: Research facility ID ORG-000853
city: Beaune
country: France
facility: Research facility ID ORG-000981
city: Boulogne sur Mer
country: France
facility: Research Facility ID ORG-000844
city: Bourgoin Jallieu
country: France
facility: Research Facility ID ORG-000869
city: Brest
country: France
facility: Research facility ID ORG-001215
city: Figeac
country: France
facility: Research Facility ID ORG-001181
city: Grenoble
country: France
facility: Research facility ID ORG-001081
city: Hazebrouck
country: France
facility: Research Facility ID ORG-000850
city: Lattes
country: France
facility: Research facility ID ORG-000855
city: Laxou
country: France
facility: Research Facility ID ORG-000859
city: Lyon
country: France
facility: Research Facility ID ORG-000830
city: Melun
country: France
facility: Research facility ORG-001362
city: Montpellier
country: France
facility: Research Facility ID ORG-001182
city: Nancy
country: France
facility: Research facility ID ORG-000836
city: Nantes
country: France
facility: Research facility ORG-001361
city: Paris
country: France
facility: Research facility ID ORG-000831
city: Paris
country: France
facility: Research Facility ID ORG-000832
city: Pezenas
country: France
facility: Research facility ID ORG-000856
city: Saint Aubin Sur Scie
country: France
facility: Research facility ID ORG-001082
city: Saint Maur
country: France
facility: Research facility ID ORG-000865
city: Tarare
country: France
facility: Research facility ID ORG-000845
city: Toulon
country: France
facility: Research facility ID ORG-001216
city: Toulouse
country: France
facility: Research facility ID ORG-001083
city: Tours
country: France
facility: Research Facility ID ORG-000862
city: Vincennes
country: France
facility: Research facility ID ORG-000835
Study officials:
affiliation: Mylan Inc.
name: Roger Lesaunier, MD
role: STUDY_DIRECTOR
References: