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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670329
Recruitment Status : Unknown
Verified August 2018 by Laboratoires URGO.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Laboratoires URGO

Study Description
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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.


Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Device: URGO2875 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non-comparative study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Acceptability of URGO2875 Dressing in the Treatment of Leg Ulcers With Inflammatory Signs
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: URGO2875
Dressing
 Device: URGO2875
Dressing


Outcome Measures
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Primary Outcome Measures :
  1. Wound surface area [ Time Frame: 4 weeks ]
    Relative wound surface area reduction (%) at the end of the four weeks of treatment


Secondary Outcome Measures :
  1. Inflammatory clinical signs [ Time Frame: 4 weeks ]
    The decrease of the clinical score, based on the presence of the five inflammatory clinical signs,

  2. Percentage of wounds with a favourable outcome [ Time Frame: 4 weeks ]
    Defined as a relative wound area reduction of at least 40% after the 4-week treatment period

  3. Time to healing [ Time Frame: 4 weeks ]
    Wound Healing time in days

  4. Healing [ Time Frame: 4 weeks ]
    Percentage of Healing wound

  5. Patient quality of life [ Time Frame: 4 weeks ]
    Patient quality of life assessed with EuroQoL 5D-5L


Other Outcome Measures:
  1. Adverse event [ Time Frame: 4 weeks ]
    Adverse event related to the use of the testing dressing (serious/ non-serious) will be described.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670329


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

Sponsors and Collaborators
Laboratoires URGO
Investigators
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Principal Investigator: GERI Ms Chloe, MD Lapeyronie Hospital, Montpellier- FRANCE
More Information
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Responsible Party: Laboratoires URGO
ClinicalTrials.gov Identifier: NCT03670329    
Other Study ID Numbers: F-08-07-AWC008
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
 Varicose Veins
Vascular Diseases
Cardiovascular Diseases