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

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: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: TulleGras M.S.; Device: Urgotul

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: CEN Biotech
• Investigators: Study Director: Roger Lesaunier, MD, Mylan Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: April 2, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: pain; randomized; healing; non-inferiority; venous leg ulcer; TulleGras; Urgotul
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: LINE4001; 2013-A01285-40 (Other Identifier: ANSM (French Health Agency) Registry number for biomedical research)