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

Venous Leg Ulcer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104180
• Other study ID #: LINE4001
• Secondary ID: 2013-A01285-40
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2017
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	Research Facility ID ORG-001183	Angoulème
France	Research Facility ID ORG-000857	Annecy
France	Research facility ID ORG-000853	Asnieres
France	Research facility ID ORG-000981	Beaune
France	Research Facility ID ORG-000844	Boulogne sur Mer
France	Research Facility ID ORG-000869	Bourgoin Jallieu
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	Pezenas
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

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	CEN Biotech

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)