Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers

Leg Ulcers Clinical Trial

Official title:

Assessment of Efficacy and Safety for a New Wound Dressing URGO 310 3166 in the Local Treatment of Venous or Mixed Leg Ulcers: A European, Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583958
• Other study ID #: FI-14-06-310 3166
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2015
• Last updated: October 20, 2015
• Start date: October 2014
• Est. completion date: June 2017

Study information

• Verified date: October 2015
• Source: Laboratoires URGO
• Contact: Sylvie Meaume, MD
• Email: sylvie.meaume[@]rth.aphp.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesGermany: Ethics CommissionUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years old who has provided his/her written informed consent,

• Patient who can be monitored by the same investigation team throughout the whole duration of the study,

• Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,

• Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,

• Ulcer area > or equal to 5cm2,

• Ulcer duration > or equal to 6 months,

• Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,

• Moderately or heavily exudative ulcers.

Exclusion Criteria:

• Clinical infection on the wound bed.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Leg Ulcers
• Ulcer

Intervention

Device:
• Urgo 3103166
URGO 310 3166 dressing should be changed as often as required (let to the Investigator's convenience). The dressing change frequency is based on the exudate level and the clinical progress of the wound (up to 7 days).
• Aquacel Extra
Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.

Locations

Country	Name	City	State
France	Hospital Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative regression of wound surface area		week 20	No
Secondary	Percentage of debrided wounds		at each clinical evaluation up to 20 weeks	No
Secondary	Occurrence of adverse events as assessed by the investigator according to a classification MedDRA		between inclusion and week 20	Yes
Secondary	Patient's Quality of Life		at inclusion visit and at week 20 or at the end of study treatment	No