<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717183</url>
  </required_header>
  <id_info>
    <org_study_id>FI-12-05-310 3113</org_study_id>
    <nct_id>NCT01717183</nct_id>
  </id_info>
  <brief_title>Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers</brief_title>
  <official_title>Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomised, Controlled, Double-blind, European Multicentre Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratoires URGO</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratoires URGO</source>
  <brief_summary>
    <textblock>
      The main purpose of this trial is to demonstrate that the new dressing is more effective than&#xD;
      the current dressing in the local treatment of chronic foot ulcers in diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of complete wound closure</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to complete wound closure</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in wound surface area</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Diabetic Foot Ulcer(s)</condition>
  <arm_group>
    <arm_group_label>URGO 310 3113 dressing - new</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>URGO 310 3113 dressing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Urgo 310 3113</intervention_name>
    <description>URGO 310 3113 dressing may be changed every 2 to 4 days, and left in place for up to 7 days, depending on the level of exudate and the wound condition</description>
    <arm_group_label>URGO 310 3113 dressing - new</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo URGO 310 3113 dressing</intervention_name>
    <arm_group_label>URGO 310 3113 dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female over 18 years old who has provided his/her written informed consent&#xD;
&#xD;
          -  Patient covered by the French national insurance system&#xD;
&#xD;
          -  Patient with Type 1 or Type 2 diabetes mellitus with glycated hemoglobi(HbA1c) levels&#xD;
             ≤ 10% (assayed in the previous 3 months. If not available, this assay must be&#xD;
             performed during the run-in period)&#xD;
&#xD;
          -  Inpatient or outpatient who can be monitored by the same investigating team throughout&#xD;
             the duration of the study&#xD;
&#xD;
          -  Patient who agrees to wear the prescribed off-loading system every day, associated&#xD;
             with the test dressing&#xD;
&#xD;
          -  DFU with adequate arterial blood supply in the target limb DFU grade I-C or II-C as&#xD;
             defined by the University of Texas Diabetic Wound Classification&#xD;
&#xD;
          -  Neuropathy confirmed by loss of protective sensation to monofilament test&#xD;
             (Semmes-Weinstein 5.07 monofilament)&#xD;
&#xD;
          -  DFU located on the toe or on the lateral, dorsal or plantar side of the foot&#xD;
&#xD;
          -  Target DFU surface area between 1 cm² and 30 cm², following debridement DFU duration&#xD;
             between 1 and 24 months&#xD;
&#xD;
          -  No local clinical infection (as defined by IDSA/IWGDF criteria) for any wound (target&#xD;
             DFU or not) on lower limbs&#xD;
&#xD;
          -  DFU adequately debrided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding woman or woman of childbearing potential not using&#xD;
             effective means of contraception&#xD;
&#xD;
          -  Patient who took part in another clinical trial in the previous month or who is to&#xD;
             take part in another clinical trial in the 20 weeks following inclusion&#xD;
&#xD;
          -  Patient with any known intolerance or allergy or reported adverse reaction to one of&#xD;
             the components of the trial dressings&#xD;
&#xD;
          -  Patient who has undergone surgery or surgical revascularization (vascular&#xD;
             reconstruction or angioplasty) in the previous 2 months&#xD;
&#xD;
          -  Patient who has presented an acute ischemic event (Acute Myocardial Infarction (AMI)&#xD;
             or stroke) in the 3 months before inclusion&#xD;
&#xD;
          -  Patient with Severe kidney failure, defined as requirement for dialysis&#xD;
&#xD;
          -  Patient with a systemic infection not controlled by suitable antibiotic treatment&#xD;
&#xD;
          -  Patient with known osteomyelitis&#xD;
&#xD;
          -  Patient with leg ulcer(s), regardless of limb&#xD;
&#xD;
          -  Patient with wounds other than the target DFU located on the heel or on the&#xD;
             interdigital part of the foot&#xD;
&#xD;
          -  Patient with an active neoplastic condition, treated by radiotherapy, chemotherapy,&#xD;
             hormone therapy or immunosuppressant agents&#xD;
&#xD;
          -  Patient treated for a chronic disease requiring high doses of systemic corticosteroids&#xD;
             (≥ 40 mg.d-1 of prednisolone or equivalent)&#xD;
&#xD;
          -  Patient with a severe illness that might lead to premature withdrawal from the trial&#xD;
&#xD;
          -  DFU for which surgery or surgical revascularization is planned at any time during the&#xD;
             study&#xD;
&#xD;
          -  Deep DFU defined as stage III or IV (University of Texas Diabetic Wound&#xD;
             Classification)&#xD;
&#xD;
          -  DFU clinically infected as defined by IDSA/IWGDF criteria&#xD;
&#xD;
          -  DFU with more than 20% of its surface area covered by black necrotic tissue following&#xD;
             debridement&#xD;
&#xD;
          -  DFU located on an amputation stump&#xD;
&#xD;
          -  DFU with neoplastic component&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jacques MARTINI, MD</last_name>
    <phone>00 33 5 61 32 32 89</phone>
  </overall_contact>
  <location>
    <facility>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacques MARTINI, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>April 10, 2014</last_update_submitted>
  <last_update_submitted_qc>April 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717183
org study id: FI-12-05-310 3113
nct id: NCT01717183
lead sponsor: 
The main purpose of this trial is to demonstrate that the new dressing is more effective than
      the current dressing in the local treatment of chronic foot ulcers in diabetic patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Percentage of complete wound closure
measure: Time to complete wound closure
measure: Change in wound surface area
arm group label: URGO 310 3113 dressing - new
arm group type: Experimental
description: flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound.
arm group label: URGO 310 3113 dressing
arm group type: Placebo Comparator
description: flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound.
intervention type: Device
intervention name: Urgo 310 3113
description: URGO 310 3113 dressing may be changed every 2 to 4 days, and left in place for up to 7 days, depending on the level of exudate and the wound condition
arm group label: URGO 310 3113 dressing - new
intervention type: Device
intervention name: Placebo URGO 310 3113 dressing
arm group label: URGO 310 3113 dressing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jacques MARTINI, MD
phone: 00 33 5 61 32 32 89
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer