Management of Infection Risk in Non-comparative Trial (MINT) | NCT03670329

Studies
Management of Infection Risk in Non-comparative Trial (MINT)

NCT03670329

Sponsor

Laboratoires URGO

Status

Unknown status

Last Update Posted

Sep 13, 2018Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Venous Leg Ulcer

Interventions

URGO2875

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2018Estimated

Primary Completion Date

Nov 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Sep 12, 2018

First Submission Date that Met QC Criteria

Sep 12, 2018

First Posted Date

Sep 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2018

Last Update Posted Date

Sep 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres. The dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.

The purpose of this non-comparative clinical trial was to evaluate the performance (efficacy and safety) of the URGO2875 dressing, on the healing process of chronic wounds presenting a high-risk of infection.

Detailed Description

The URGO2875 dressing is indicated for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
URGO2875	Experimental	Dressing	Device: URGO2875

Name	Type	Description	Arm Group Labels	Other Names
URGO2875	Device	Dressing	URGO2875

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound surface area	Relative wound surface area reduction (%) at the end of the four weeks of treatment	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Inflammatory clinical signs	The decrease of the clinical score, based on the presence of the five inflammatory clinical signs,	4 weeks
Percentage of wounds with a favourable outcome	Defined as a relative wound area reduction of at least 40% after the 4-week treatment period

Other Outcomes

Measure	Description	Time Frame
Adverse event	Adverse event related to the use of the testing dressing (serious/ non-serious) will be described.	4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient, aged ≥ 18 years, who signed and dated informed consent form,
Patients affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.7 and ≤ 1.3),
Patient willing and able to wear an effective venous compression system every day during the study period,
Patient with at least three of the five inflammatory clinical signs : pain between dressing changes, periwound erythema, local oedema, malodour and presence of heavy exudate.

Exclusion Criteria:

Patients under guardianship or protection of vulnerable adult
Pregnancy or breastfeeding women,
Childbearing potential women with no medically-acceptable method of birth control,
Patients included in another clinical study,
Patients with known allergy with hydrocolloid (carboxymethylcellulose CMC), silicone or silver,
Patients with wound covered partially or totally with necrotic tissue,
Patients who had within the 3 months prior the inclusion, deep vein thrombosis
Patients with a serious general disease that deemed to interfere with the treatment period and evaluation
Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy or hormone therapy
Patients with non-controlled systemic infection by an suitable antibiotic therapy
Patients with clinically infected wound
Patients with wound requiring surgical treatment or for which surgery is scheduled during the study period
Patients with known cancerous lesions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
BATOT Ms Geraldine, PhD	Contact	+33 (0)3 80 44 28 46		g.batot@fr.urgo.com
TACCA Mr Olivier, PhD	Contact	+33 (0)3 80 44 74 22		o.tacca@fr.urgo.com

ID	Term
D014648	Varicose Veins
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer