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
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
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
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
NCT ID
NCT03670329
First Posted
September 12, 2018
Last Updated
September 12, 2018
Sponsor
Laboratoires URGO
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