<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/NCT03782129</url>
  </required_header>
  <id_info>
    <org_study_id>CIC1421-18-16</org_study_id>
    <nct_id>NCT03782129</nct_id>
  </id_info>
  <brief_title>Five-year Mortality Rate in People With Diabetic Foot Ulcer</brief_title>
  <acronym>DIAFOOT</acronym>
  <official_title>Five-year Mortality Rate in People With Diabetic Foot Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier Pitie-Salpetriere</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Hospitalier Pitie-Salpetriere</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As the global mortality rate decreases for diabetics patients, further explorations and datas&#xD;
      are needed about the specific population of diabetics patients suffering a Diabetic Foot&#xD;
      Ulcer (DFU).&#xD;
&#xD;
      This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer&#xD;
      occurring in 2010.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetic foot ulcer (DFU) is an economic burden for many countries around the world. It also&#xD;
      induces a dramatic decrease in physical, emotional, and social functioning for patients.&#xD;
      Oftenly associated with advanced micro and macrovascular complications, high morbidity and a&#xD;
      greater risk of premature death (mainly by Ischemic Heart Disease) occure.&#xD;
&#xD;
      Only few studies explored DFU patients' long term survival: the few datas coming from cohorts&#xD;
      in the 2000's reported mortality rates around 45% at five years after DFU's diagnosis.&#xD;
&#xD;
      But life expectancy in diabetics patients imporved during last decade. So the main objective&#xD;
      of our study is to evaluate the diabetics patients' 5 years mortality rate, in whom DFU was&#xD;
      diagnosed in 2010.&#xD;
&#xD;
      Moreover, our secondary objective is to identify the mortality's predictive factors in 2010.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2009</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate 5 years after DFU diagnosis</measure>
    <time_frame>5 years</time_frame>
    <description>Five years after DFU diagnosis, patients are called by phone to enquire their health. If patients are dead, family tell us. If no family is available, the City Hall is called to check the death list.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risks factors correlated to mortality rate among DFU patients diagnosed in 2010</measure>
    <time_frame>5 years</time_frame>
    <description>All relevants staisticals associations between mortality rate and DFU diagnosed in 2010</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">347</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Diabetic Foot</condition>
  <condition>Diabetes Complications</condition>
  <arm_group>
    <arm_group_label>Diabetic patients with DFU</arm_group_label>
    <description>Diabetic patients with DFU diagnosed in 2010</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>blood samples</intervention_name>
    <description>Blood samples drawn during hospitalisations when needed</description>
    <arm_group_label>Diabetic patients with DFU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical exam and DFU medical cares</intervention_name>
    <description>Clinical exam and DFU's medical cares at each visit (planned evry 1 to 3 months), during all the 5 years follow up, or until death.</description>
    <arm_group_label>Diabetic patients with DFU</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Diabetic patients with a DFU diagnosed in 2010&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 1 or 2 diabetes&#xD;
&#xD;
          -  consultation for new diabetic foot ulcer during the year 2010&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Groupe Hospitalier Pitie-Salpetriere</investigator_affiliation>
    <investigator_full_name>Joe Elie Salem</investigator_full_name>
    <investigator_title>Assistant director, clinical investigation center Paris Est</investigator_title>
  </responsible_party>
  <keyword>diabetes mellitus</keyword>
  <keyword>diabetic foot</keyword>
  <keyword>mortality rate</keyword>
  <keyword>diabetes complications</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03782129
org study id: CIC1421-18-16
nct id: NCT03782129
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
As the global mortality rate decreases for diabetics patients, further explorations and datas
      are needed about the specific population of diabetics patients suffering a Diabetic Foot
      Ulcer (DFU).

      This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer
      occurring in 2010.
Diabetic foot ulcer (DFU) is an economic burden for many countries around the world. It also
      induces a dramatic decrease in physical, emotional, and social functioning for patients.
      Oftenly associated with advanced micro and macrovascular complications, high morbidity and a
      greater risk of premature death (mainly by Ischemic Heart Disease) occure.

      Only few studies explored DFU patients' long term survival: the few datas coming from cohorts
      in the 2000's reported mortality rates around 45% at five years after DFU's diagnosis.

      But life expectancy in diabetics patients imporved during last decade. So the main objective
      of our study is to evaluate the diabetics patients' 5 years mortality rate, in whom DFU was
      diagnosed in 2010.

      Moreover, our secondary objective is to identify the mortality's predictive factors in 2010.
observational model: Cohort
time perspective: Prospective
measure: Mortality rate 5 years after DFU diagnosis
time frame: 5 years
description: Five years after DFU diagnosis, patients are called by phone to enquire their health. If patients are dead, family tell us. If no family is available, the City Hall is called to check the death list.
measure: Risks factors correlated to mortality rate among DFU patients diagnosed in 2010
time frame: 5 years
description: All relevants staisticals associations between mortality rate and DFU diagnosed in 2010
arm group label: Diabetic patients with DFU
description: Diabetic patients with DFU diagnosed in 2010
intervention type: Biological
intervention name: blood samples
description: Blood samples drawn during hospitalisations when needed
arm group label: Diabetic patients with DFU
intervention type: Other
intervention name: Clinical exam and DFU medical cares
description: Clinical exam and DFU's medical cares at each visit (planned evry 1 to 3 months), during all the 5 years follow up, or until death.
arm group label: Diabetic patients with DFU
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Groupe Hospitalier Pitie-Salpetriere
investigator full name: Joe Elie Salem
investigator title: Assistant director, clinical investigation center Paris Est
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Diabetes Mellitus
mesh term: Diabetes Complications
sharing ipd: Undecided