<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/NCT02986256</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01136-45</org_study_id>
    <nct_id>NCT02986256</nct_id>
  </id_info>
  <brief_title>Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients</brief_title>
  <acronym>TELEPIED</acronym>
  <official_title>Comparative Study, Randomized in Parallel Groups, Evaluating the Consequences of the Management of Diabetic Foot Ulcers by Telemedicine Versus Conventional Monitoring on the Number of Hospital Days in Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The TELEPIED project aims to show that it is possible to reduce the number of hospitalization&#xD;
      days of a patient with ulcers of the foot thanks to a new organization of care, based on the&#xD;
      intervention of a coordinating nurse interacting with the nurse in charge of the patient&#xD;
      thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular&#xD;
      follow-up of the evolution of the wound and adapting the support nurse to the home if&#xD;
      necessary.&#xD;
&#xD;
      It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of&#xD;
      the foot.&#xD;
&#xD;
      Patients included in the conventional group will be followed according to the usual practice&#xD;
      Patients included in the &quot;telepied&quot; group will benefit from a personalized accompaniment by a&#xD;
      nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting&#xD;
      by delegating tasks of the investigator.&#xD;
&#xD;
      The patient will be visited by the referring nurse every 15 days. During these visits, the&#xD;
      referring nurse will have the objective to evaluate the evolution of the ulcer as well as the&#xD;
      care performed. This visit also allows a close personalized accompaniment for the patient,&#xD;
      who will benefit from an education adapted to the characteristics of ulcer (discharge&#xD;
      modalities for example ..) and its way of life.&#xD;
&#xD;
      Every patients will be followed for one year (12 months).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Actual">May 12, 2020</completion_date>
  <primary_completion_date type="Actual">May 12, 2020</primary_completion_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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of hospitalization days related to diabetic foot ulcers after one year of follow-up</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total direct care costs between the Telepied group and the control group</measure>
    <time_frame>12 months</time_frame>
    <description>hospitalization costs, transport costs, nursing costs, liberal nursing costs, material costs, number of consultations with the doctor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ulcer recidivism rate in the Telepied group versus control group.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of ulceration</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of ulceration</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healing rate between the Telepied group and the control group</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputation rate between the two groups</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Ulcer Foot</condition>
  <arm_group>
    <arm_group_label>Conventionnal Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention for this group. Patients will be followed by a usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Telepied&quot; Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be followed by a nurse referring to ulcers of the diabetic foot.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Taking pictures</intervention_name>
    <description>Photograph of foot ulcer with transmission to referring nurse 1 time per week</description>
    <arm_group_label>&quot;Telepied&quot; Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Visit at home</intervention_name>
    <description>Home visit by the referring nurse every 15 days</description>
    <arm_group_label>&quot;Telepied&quot; Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years&#xD;
&#xD;
          -  Diabetic patients with foot ulcer&#xD;
&#xD;
          -  Patient who agreed to participate in the study and sign free and informed consent&#xD;
&#xD;
          -  Patient affiliated to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant Woman&#xD;
&#xD;
          -  Patient deprived of liberty by a judicial or administrative decision or a person&#xD;
             subject to a legal protection measure&#xD;
&#xD;
          -  Patient already involved in another clinical trial protocol&#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_official>
    <last_name>Dured Dardari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Sud Francilien</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Sud-Francilien</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>telemedicine</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02986256
org study id: 2016-A01136-45
nct id: NCT02986256
lead sponsor: 
has dmc: No
The TELEPIED project aims to show that it is possible to reduce the number of hospitalization
      days of a patient with ulcers of the foot thanks to a new organization of care, based on the
      intervention of a coordinating nurse interacting with the nurse in charge of the patient
      thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular
      follow-up of the evolution of the wound and adapting the support nurse to the home if
      necessary.

      It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of
      the foot.

      Patients included in the conventional group will be followed according to the usual practice
      Patients included in the "telepied" group will benefit from a personalized accompaniment by a
      nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting
      by delegating tasks of the investigator.

      The patient will be visited by the referring nurse every 15 days. During these visits, the
      referring nurse will have the objective to evaluate the evolution of the ulcer as well as the
      care performed. This visit also allows a close personalized accompaniment for the patient,
      who will benefit from an education adapted to the characteristics of ulcer (discharge
      modalities for example ..) and its way of life.

      Every patients will be followed for one year (12 months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of hospitalization days related to diabetic foot ulcers after one year of follow-up
time frame: 12 months
measure: Total direct care costs between the Telepied group and the control group
time frame: 12 months
description: hospitalization costs, transport costs, nursing costs, liberal nursing costs, material costs, number of consultations with the doctor
measure: Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group
time frame: 12 months
measure: Ulcer recidivism rate in the Telepied group versus control group.
time frame: 12 months
measure: Frequency of ulceration
time frame: 12 months
measure: Duration of ulceration
time frame: 12 months
measure: Healing rate between the Telepied group and the control group
time frame: 12 months
measure: Amputation rate between the two groups
time frame: 12 months
measure: Patient satisfaction score
time frame: 12 months
arm group label: Conventionnal Group
arm group type: No Intervention
description: No intervention for this group. Patients will be followed by a usual care.
arm group label: "Telepied" Group
arm group type: Experimental
description: Patients will be followed by a nurse referring to ulcers of the diabetic foot.
intervention type: Behavioral
intervention name: Taking pictures
description: Photograph of foot ulcer with transmission to referring nurse 1 time per week
arm group label: "Telepied" Group
intervention type: Behavioral
intervention name: Visit at home
description: Home visit by the referring nurse every 15 days
arm group label: "Telepied" Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dured Dardari, MD
role: Principal Investigator
affiliation: Centre Hospitalier Sud Francilien
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No