<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/NCT01673412</url>
  </required_header>
  <id_info>
    <org_study_id>AOL02-DR-LOK</org_study_id>
    <secondary_id>02H37</secondary_id>
    <nct_id>NCT01673412</nct_id>
  </id_info>
  <brief_title>Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers</brief_title>
  <official_title>Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut de Recherches Internationales Servier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Société de Dermatologie Française</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU)&#xD;
      characteristics known as possible prognostic markers, and which sociodemographic and&#xD;
      psychologic factors associated with VLU are associated with complete healing at 24 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2003</start_date>
  <completion_date type="Actual">December 2008</completion_date>
  <primary_completion_date type="Actual">June 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Healing or non-healing of venous leg ulcers at week 24</measure>
    <time_frame>week 24</time_frame>
    <description>Healing or non-healing of venous leg ulcers at week 24</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical characteristics</measure>
    <time_frame>week 24</time_frame>
    <description>comparison between healed and non healed venous leg ulcers at week 24 for patient clinical characteristics (age, weight, body mass index, concomitant diseases, medical and surgical history, autonomy, mobility)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>biologic characteristics</measure>
    <time_frame>week 24</time_frame>
    <description>comparison between healed and non healed venous leg ulcers at week 24 for patient biologic characteristics (complete blood count, hemoglobinemia, albuminemia, and only for patients with diabetes mellitus : glycemia and glycated haemoglobin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>psychologic assessments</measure>
    <time_frame>week 24</time_frame>
    <description>comparison between healed and non healed venous leg ulcers at week 24 for patient psychologic assessments (self-esteem assessed by Coopersmith self-esteem inventory, symptoms of depression researched with Beck Depression Inventory)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cognitive assessments</measure>
    <time_frame>week 24</time_frame>
    <description>comparison between healed and non healed venous leg ulcers at week 24 for patient cognitive assessments (intellectual quotient evaluated by Raven's progressives matrices test, signs of intellectual deterioration assessed by Minimal Mental Status test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>social assessment</measure>
    <time_frame>week 24</time_frame>
    <description>comparison between healed and non healed venous leg ulcers at week 24 for patient social assessments (assessment of social and occupational group, of education level, of income level and of marital status)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>affected-leg characteristics</measure>
    <time_frame>week 24</time_frame>
    <description>comparison between healed and non healed venous leg ulcers at week 24 for patient affected-leg inclusion characteristics (venous insufficiency classified using CEAP classification, ultrasonography assessment of leg with measurement of the Ankle Brachial Index (ABI) and examination of the leg venous system, number of ulcers on target leg, presence/absence of venous abnormalities (varicose veins, ochre dermatitis, white atrophy, acute hypodermitis), of cutaneous signs of lymphatic insufficiency, of oedema and of ankle articulation ankylosis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>venous leg ulcers inclusion characteristics</measure>
    <time_frame>week 24</time_frame>
    <description>comparison between healed and non healed venous leg ulcers at week 24 for patient venous leg ulcers inclusion characteristics (size, localization, duration, percentage of granulation/fibrinous tissue, aspect of ulcer's margins, pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>venous insufficiency treatment</measure>
    <time_frame>week 24</time_frame>
    <description>comparison between healed and non healed venous leg ulcers at week 24 for patient venous insufficiency treatment (compliance to venous contention assessed by an evaluating questionnaire)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Leg Ulcer</condition>
  <arm_group>
    <arm_group_label>interventional arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psychological tests</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychological tests</intervention_name>
    <description>social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status</description>
    <arm_group_label>interventional arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ambulatory or hospitalized patients&#xD;
&#xD;
          -  patients over 50 years old&#xD;
&#xD;
          -  one or more venous leg ulcer, lasting for 1 month or more&#xD;
&#xD;
          -  wound area more than 1 cm2&#xD;
&#xD;
          -  clinical findings consistent with established venous disease (skin hyperpigmentation,&#xD;
             varicose veins, lipodermatosclerosis), confirmed by venous Doppler duplex&#xD;
             ultrasonography performed during the preceding 6 months&#xD;
&#xD;
          -  absence of significant arterial insufficiency assessed by clinical findings&#xD;
             (intermittent claudication or resting pain, necrotic or distal foot wound) and by an&#xD;
             ankle brachial index (ABI) ≥0.8&#xD;
&#xD;
          -  ability to give informed consent&#xD;
&#xD;
          -  ability to be followed for 24 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ongoing systemic diseases known to be associated with pyoderma gangrenosum or&#xD;
             necrotizing vasculitis&#xD;
&#xD;
          -  corticosteroid, cytotoxic or immunosuppressant drug use during the preceding 3 months&#xD;
&#xD;
          -  hypertensive leg ulcer&#xD;
&#xD;
          -  foot ulcer&#xD;
&#xD;
          -  ABI &lt; 0.8&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine LOK, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalo-Universitaire d'Amiens</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalo-Universitaire d'Amiens - Dermatologie</name>
      <address>
        <city>Amiens</city>
        <zip>80000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I</name>
      <address>
        <city>Amiens</city>
        <zip>80000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Victor Dupouy - Dermatologie</name>
      <address>
        <city>Argenteuil</city>
        <zip>95100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Jacques - Dermatologie 1</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Brest - Dermatologie</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clémenceau - Dermatologie</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Civils de Colmar - Service de Dermatologie</name>
      <address>
        <city>Colmar</city>
        <zip>68024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bocage - Dermatologie</name>
      <address>
        <city>Dijon</city>
        <zip>21034</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Michallon - Dermatologie</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital C. Foix - Service de Gérontologie</name>
      <address>
        <city>Ivry</city>
        <zip>94205</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier - Service de Médecine Interne</name>
      <address>
        <city>Lens</city>
        <zip>62307</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert Boulin - Dermatologie</name>
      <address>
        <city>Libourne</city>
        <zip>33500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Claude Huriez - Clinique Dermatologique</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Dupuytren - Dermatologie</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Philibert - Dermatologie</name>
      <address>
        <city>Lomme</city>
        <zip>59462</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital d'Instruction des Armées Desgenettes</name>
      <address>
        <city>Lyon</city>
        <zip>69998</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Sainte Marguerite - Dermatologie</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital SAint Charles - Dermatologie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Fournier</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Rothschild - Consultation de Dermatologie</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bichat - Service de Dermatologie</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Louis - Service de Dermatologie</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Broussais - Rééducation Vasculaire</name>
      <address>
        <city>Paris</city>
        <zip>75674</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital du Haut Levêque - Dermatologie</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Laennec - Dermatologie</name>
      <address>
        <city>Quimper</city>
        <zip>29107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Robert Debré</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet de Dermatologie 43, rue Jean Lecanuet</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles NICOLLE - Service de Dermatologie</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Royal Parc - Dermatologie</name>
      <address>
        <city>Saint Brieuc</city>
        <zip>22000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal Poissy Saint Germain</name>
      <address>
        <city>Saint Germain en Laye</city>
        <zip>78100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet de Dermatologie 1,rue dembarrère</name>
      <address>
        <city>Tarbes</city>
        <zip>65000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Beauregard</name>
      <address>
        <city>Thionville</city>
        <zip>57100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Trousseau - Dermatologie</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Valence - Dermatologie</name>
      <address>
        <city>Valence</city>
        <zip>26000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 23, 2012</last_update_submitted>
  <last_update_submitted_qc>August 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>venous leg ulcer healing prognostic factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Leg 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/NCT01673412
org study id: AOL02-DR-LOK
secondary id: 02H37
nct id: NCT01673412
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU)
      characteristics known as possible prognostic markers, and which sociodemographic and
      psychologic factors associated with VLU are associated with complete healing at 24 weeks.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Healing or non-healing of venous leg ulcers at week 24
time frame: week 24
description: Healing or non-healing of venous leg ulcers at week 24
measure: clinical characteristics
time frame: week 24
description: comparison between healed and non healed venous leg ulcers at week 24 for patient clinical characteristics (age, weight, body mass index, concomitant diseases, medical and surgical history, autonomy, mobility)
measure: biologic characteristics
time frame: week 24
description: comparison between healed and non healed venous leg ulcers at week 24 for patient biologic characteristics (complete blood count, hemoglobinemia, albuminemia, and only for patients with diabetes mellitus : glycemia and glycated haemoglobin)
measure: psychologic assessments
time frame: week 24
description: comparison between healed and non healed venous leg ulcers at week 24 for patient psychologic assessments (self-esteem assessed by Coopersmith self-esteem inventory, symptoms of depression researched with Beck Depression Inventory)
measure: cognitive assessments
time frame: week 24
description: comparison between healed and non healed venous leg ulcers at week 24 for patient cognitive assessments (intellectual quotient evaluated by Raven's progressives matrices test, signs of intellectual deterioration assessed by Minimal Mental Status test)
measure: social assessment
time frame: week 24
description: comparison between healed and non healed venous leg ulcers at week 24 for patient social assessments (assessment of social and occupational group, of education level, of income level and of marital status)
measure: affected-leg characteristics
time frame: week 24
description: comparison between healed and non healed venous leg ulcers at week 24 for patient affected-leg inclusion characteristics (venous insufficiency classified using CEAP classification, ultrasonography assessment of leg with measurement of the Ankle Brachial Index (ABI) and examination of the leg venous system, number of ulcers on target leg, presence/absence of venous abnormalities (varicose veins, ochre dermatitis, white atrophy, acute hypodermitis), of cutaneous signs of lymphatic insufficiency, of oedema and of ankle articulation ankylosis)
measure: venous leg ulcers inclusion characteristics
time frame: week 24
description: comparison between healed and non healed venous leg ulcers at week 24 for patient venous leg ulcers inclusion characteristics (size, localization, duration, percentage of granulation/fibrinous tissue, aspect of ulcer's margins, pain)
measure: venous insufficiency treatment
time frame: week 24
description: comparison between healed and non healed venous leg ulcers at week 24 for patient venous insufficiency treatment (compliance to venous contention assessed by an evaluating questionnaire)
arm group label: interventional arm
arm group type: Experimental
description: Psychological tests
intervention type: Other
intervention name: Psychological tests
description: social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status
arm group label: interventional arm
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine LOK, PhD
role: Principal Investigator
affiliation: Centre Hospitalo-Universitaire d'Amiens
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country: France
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Leg Ulcer
mesh term: Ulcer