Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers (CASSIOPEE)

Assessment of Efficacy, Tolerance and Acceptability of Urgo 310 3166 Dressing in the Treatment of Local Venous or Mixed Leg Ulcers

Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.

Study Overview

• Status: Completed
• Conditions: Ulcers, Leg
• Intervention / Treatment: Device: Urgo 310 3166 dressing

Detailed Description

Assessment of efficacy, tolerance and acceptability of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers: multicenter trial, conducted in France.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Chenôve, France
    • URGO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female over 18 years old who has provided his/her written informed consent
2. Patient who can be monitored by the same investigation team throughout the whole duration of the study
3. Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing
4. Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3
5. Ulcer area between 3 and 20 cm2
6. Ulcer duration between 3 and 18 months,
7. Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue
8. Moderately or heavily exudative ulcers.

Exclusion Criteria:

A. Clinical infection on the wound bed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urgo 310 3166 dressing	Device: Urgo 310 3166 dressing; Experimental: Urgo 310 3166 dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - % of Wound Area Regression (WAR	% of Wound Area Regression (WAR), as a measure of efficacy	at week 12

Collaborators and Investigators

• Sponsor: Laboratoires URGO

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Actual): May 22, 2018
• Study Completion (Actual): July 16, 2018

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Leg Ulcer
• Other Study ID Numbers: F-17-02-310 3166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No