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

Efficacy and Acceptability of URGO2875 Dressing in the Treatment of Leg Ulcers With Inflammatory Signs

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.

Study Overview

• Status: Unknown
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: URGO2875

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: URGO2875; Dressing	Device: URGO2875; Dressing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	4 weeks
Time to healing	Wound Healing time in days	4 weeks
Healing	Percentage of Healing wound	4 weeks
Patient quality of life	Patient quality of life assessed with EuroQoL 5D-5L	4 weeks

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laboratoires URGO
• Investigators: Principal Investigator: GERI Ms Chloe, MD, Lapeyronie Hospital, Montpellier- FRANCE

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: F-08-07-AWC008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No