Back to resultsAssessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers (CASSIOPEE)
Primary Purpose
Ulcers, Leg
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urgo 310 3166 dressing
Sponsored by
About this trial
This is an interventional treatment trial for Ulcers, Leg
Eligibility Criteria
Inclusion Criteria:
- Male or female 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 between 3 and 20 cm2
- Ulcer duration between 3 and 18 months,
- Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue
- Moderately or heavily exudative ulcers.
Exclusion Criteria:
A. Clinical infection on the wound bed.
Sites / Locations
- URGO
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Urgo 310 3166 dressing
Arm Description
Urgo 310 3166 dressing
Outcomes
Primary Outcome Measures
Efficacy - % of Wound Area Regression (WAR
% of Wound Area Regression (WAR), as a measure of efficacy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03126396
Brief Title
Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers
Acronym
CASSIOPEE
Official Title
Assessment of Efficacy, Tolerance and Acceptability of Urgo 310 3166 Dressing in the Treatment of Local Venous or Mixed Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
May 22, 2018 (Actual)
Study Completion Date
July 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires URGO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcers, Leg
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urgo 310 3166 dressing
Arm Type
Experimental
Arm Description
Urgo 310 3166 dressing
Intervention Type
Device
Intervention Name(s)
Urgo 310 3166 dressing
Intervention Description
Experimental: Urgo 310 3166 dressing
Primary Outcome Measure Information:
Title
Efficacy - % of Wound Area Regression (WAR
Description
% of Wound Area Regression (WAR), as a measure of efficacy
Time Frame
at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female 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 between 3 and 20 cm2
Ulcer duration between 3 and 18 months,
Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue
Moderately or heavily exudative ulcers.
Exclusion Criteria:
A. Clinical infection on the wound bed.
Facility Information:
Facility Name
URGO
City
Chenôve
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers
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