NCT03126396

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

May 11, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

April 11, 2017

Last Update Submit

December 12, 2019

Conditions

Ulcers, Leg

Outcome Measures

Primary Outcomes (1)

  • Efficacy - % of Wound Area Regression (WAR

    % of Wound Area Regression (WAR), as a measure of efficacy

    at week 12

Study Arms (1)

Urgo 310 3166 dressing

EXPERIMENTAL

Urgo 310 3166 dressing

Device: Urgo 310 3166 dressing

Interventions

Urgo 310 3166 dressingDEVICE

Experimental: Urgo 310 3166 dressing

Urgo 310 3166 dressing

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • A. Clinical infection on the wound bed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

URGO

Chenôve, France

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 24, 2017

Study Start

May 11, 2017

Primary Completion

May 22, 2018

Study Completion

July 16, 2018

Last Updated

December 16, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)