search
Back to results

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

Primary Purpose

Venous Leg Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
URGO2875
Sponsored by
Laboratoires URGO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    URGO2875

    Arm Description

    Dressing

    Outcomes

    Primary Outcome Measures

    Wound surface area
    Relative wound surface area reduction (%) at the end of the four weeks of treatment

    Secondary Outcome Measures

    Inflammatory clinical signs
    The decrease of the clinical score, based on the presence of the five inflammatory clinical signs,
    Percentage of wounds with a favourable outcome
    Defined as a relative wound area reduction of at least 40% after the 4-week treatment period
    Time to healing
    Wound Healing time in days
    Healing
    Percentage of Healing wound
    Patient quality of life
    Patient quality of life assessed with EuroQoL 5D-5L

    Full Information

    First Posted
    September 12, 2018
    Last Updated
    September 12, 2018
    Sponsor
    Laboratoires URGO
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03670329
    Brief Title
    Management of Infection Risk in Non-comparative Trial (MINT)
    Acronym
    MINT
    Official Title
    Efficacy and Acceptability of URGO2875 Dressing in the Treatment of Leg Ulcers With Inflammatory Signs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2018 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    November 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Laboratoires URGO

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Leg Ulcer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Non-comparative study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    URGO2875
    Arm Type
    Experimental
    Arm Description
    Dressing
    Intervention Type
    Device
    Intervention Name(s)
    URGO2875
    Intervention Description
    Dressing
    Primary Outcome Measure Information:
    Title
    Wound surface area
    Description
    Relative wound surface area reduction (%) at the end of the four weeks of treatment
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Inflammatory clinical signs
    Description
    The decrease of the clinical score, based on the presence of the five inflammatory clinical signs,
    Time Frame
    4 weeks
    Title
    Percentage of wounds with a favourable outcome
    Description
    Defined as a relative wound area reduction of at least 40% after the 4-week treatment period
    Time Frame
    4 weeks
    Title
    Time to healing
    Description
    Wound Healing time in days
    Time Frame
    4 weeks
    Title
    Healing
    Description
    Percentage of Healing wound
    Time Frame
    4 weeks
    Title
    Patient quality of life
    Description
    Patient quality of life assessed with EuroQoL 5D-5L
    Time Frame
    4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Adverse event
    Description
    Adverse event related to the use of the testing dressing (serious/ non-serious) will be described.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    BATOT Ms Geraldine, PhD
    Phone
    +33 (0)3 80 44 28 46
    Email
    g.batot@fr.urgo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    TACCA Mr Olivier, PhD
    Phone
    +33 (0)3 80 44 74 22
    Email
    o.tacca@fr.urgo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GERI Ms Chloe, MD
    Organizational Affiliation
    Lapeyronie Hospital, Montpellier- FRANCE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs