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

Venous Leg Ulcer Clinical Trial

— MINT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03670329
• Other study ID #: F-08-07-AWC008
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: November 2019

Study information

• Verified date: August 2018
• Source: Laboratoires URGO
• Contact: BATOT Ms Geraldine, PhD
• Phone: +33 (0)3 80 44 28 46
• Email: g.batot[@]fr.urgo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• URGO2875
Dressing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse event	Adverse event related to the use of the testing dressing (serious/ non-serious) will be described.	4 weeks
Primary	Wound surface area	Relative wound surface area reduction (%) at the end of the four weeks of treatment	4 weeks
Secondary	Inflammatory clinical signs	The decrease of the clinical score, based on the presence of the five inflammatory clinical signs,	4 weeks
Secondary	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
Secondary	Time to healing	Wound Healing time in days	4 weeks
Secondary	Healing	Percentage of Healing wound	4 weeks
Secondary	Patient quality of life	Patient quality of life assessed with EuroQoL 5D-5L	4 weeks