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

Primary Purpose

Leg Ulcers

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Urgo 3103166

Aquacel Extra

About this trial

This is an interventional treatment trial for Leg Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital RothschildRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device Urgo 3103166

Device Aquacel Extra

Arm Description

Soft-adherent hydro-desloughing dressing

Hydrofibre dressing

Outcomes

Primary Outcome Measures

Relative regression of wound surface area

Secondary Outcome Measures

Percentage of debrided wounds

Occurrence of adverse events as assessed by the investigator according to a classification MedDRA

Patient's Quality of Life

Full Information

NCT ID

NCT02583958

First Posted

October 12, 2015

Last Updated

October 20, 2015

Sponsor

Laboratoires URGO

1. Study Identification

Unique Protocol Identification Number

NCT02583958

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoires URGO

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leg Ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Arm Title

Device Urgo 3103166

Arm Type

Experimental

Arm Description

Soft-adherent hydro-desloughing dressing

Arm Title

Device Aquacel Extra

Arm Type

Active Comparator

Arm Description

Hydrofibre dressing

Intervention Type

Device

Intervention Name(s)

Urgo 3103166

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Aquacel Extra

Intervention Description

Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.

Primary Outcome Measure Information:

Title

Relative regression of wound surface area

Time Frame

week 20

Secondary Outcome Measure Information:

Title

Percentage of debrided wounds

Time Frame

at each clinical evaluation up to 20 weeks

Title

Occurrence of adverse events as assessed by the investigator according to a classification MedDRA

Time Frame

between inclusion and week 20

Title

Patient's Quality of Life

Time Frame

at inclusion visit and at week 20 or at the end of study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sylvie Meaume, MD

sylvie.meaume@rth.aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sylvie Meaume, MD

Organizational Affiliation

Hospital Rothschild - Paris - France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Rothschild

City

Paris

ZIP/Postal Code

75012

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sylvie Meaume, MD

12. IPD Sharing Statement

Learn more about this trial

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

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