NCT03126396

Completed

Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing...

Laboratoires URGO Source

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Other study identifiers

Sponsor study identifier

F-17-02-310 3166

Study Type

interventional

Actual enrollment (reported)

51

Locations

1 country

Sites

1

Timeline

Study Start

May 11, 2017

Actual (reported)

Primary Completion

May 22, 2018

Actual (reported)

Study Completion

July 16, 2018

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 51 participants
Study completion date: July 16, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 11, 2017
Actual (reported)
First Posted
April 24, 2017
Actual (reported)
Study Start
May 11, 2017
Actual (reported)
Primary Completion
May 22, 2018
Actual (reported)
Study Completion
July 16, 2018
Actual (reported)

Last Updated: December 16, 2019
Status Verified: December 2019
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Laboratoires URGO
Industrylead

Study Sites (1)

URGO

Chenôve, France

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Enrollment

51 participants (actual enrollment reported by the registry).

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

Actual (reported)

Unknown

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Not ApplicableUnknown

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Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

Not ApplicableCompleted

NCT02509533

Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method

Not ApplicableTerminated

NCT01673412

Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Not ApplicableCompleted

NCT03186560

Speckle Study: In Arterial, Mixed and Diabetic Foot Ulcers

Not ApplicableTerminated

NCT02011503

Use of dHACM in the Treatment of Venous Leg Ulcers

Not ApplicableCompleted

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.

Primary Completion

May 22, 2018

Actual (reported)

Study Completion

July 16, 2018

Actual (reported)

Last Updated

December 16, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03126396
Data provider: ClinicalTrials.gov
Source updated: 2019-12-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:16 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Urgo 310 3166 dressing

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations