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

NCT ID: NCT03126396

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2018-07-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Ulcers, Leg

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Urgo 310 3166 dressing

Urgo 310 3166 dressing

Group Type EXPERIMENTAL

Urgo 310 3166 dressing

Intervention Type DEVICE

Experimental: Urgo 310 3166 dressing

Interventions

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Urgo 310 3166 dressing

Experimental: Urgo 310 3166 dressing

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires URGO

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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URGO

Chenôve, , France

Site Status

Countries

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France

Other Identifiers

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F-17-02-310 3166

Identifier Type: -

Identifier Source: org_study_id