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

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

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.

Study Overview

• Status: Unknown
• Conditions: Leg Ulcers
• Intervention / Treatment: Device: Urgo 3103166; Device: Aquacel Extra

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Hospital Rothschild
    • Contact: Sylvie Meaume, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Urgo 3103166; Soft-adherent hydro-desloughing dressing	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).
Active Comparator: Device Aquacel Extra; Hydrofibre dressing	Device: Aquacel Extra; Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative regression of wound surface area	week 20

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of debrided wounds	at each clinical evaluation up to 20 weeks
Occurrence of adverse events as assessed by the investigator according to a classification MedDRA	between inclusion and week 20
Patient's Quality of Life	at inclusion visit and at week 20 or at the end of study treatment

Collaborators and Investigators

• Sponsor: Laboratoires URGO
• Investigators: Principal Investigator: Sylvie Meaume, MD, Hospital Rothschild - Paris - France

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Leg Ulcer; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: FI-14-06-310 3166