<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/NCT04440839</url>
  </required_header>
  <id_info>
    <org_study_id>1598596</org_study_id>
    <nct_id>NCT04440839</nct_id>
  </id_info>
  <brief_title>Implementation of Telemedicine for Patient With Lower Extremity Wounds</brief_title>
  <official_title>Implementation of Telemedicine for Patient With Lower Extremity Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine if patients with lower extremity wounds in rural&#xD;
      communities who undergo specialty referral through telemedicine have expedited care compared&#xD;
      to patients who are treated through standard in person referral.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a clustered trial where patients identified as having lower extremity ulcers with&#xD;
      peripheral artery disease and diabetes are given the option to be seen by specialty care&#xD;
      providers through telemedicine vs. normal standard in person referral. The study is being&#xD;
      conducted in rural areas where there are no in person vascular surgery providers. The aim of&#xD;
      the study is to determine if patient activation affects likelihood to use telemedicine and if&#xD;
      use of telemedicine can expedite speciality care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients identified as having a lower extremity wound with peripheral artery disease or diabetes mellitus are offered a telemedicine consult. Patients are then followed for time to consultation, time to revascularization if needed, and time to wound healing.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Specialty Consultation</measure>
    <time_frame>up to 365 days</time_frame>
    <description>The time from the date the wound is identified to the date of specialist consultation, in days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Revascularization</measure>
    <time_frame>up to 365 days</time_frame>
    <description>The time from the date the wound is identified to the procedure to evaluation or improve blood flow for the index leg, in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>up to 365 days</time_frame>
    <description>Number of hospitalizations for the index leg and wound, from the time the wound is identified to the time the wound heals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency room visits</measure>
    <time_frame>up to 365 days</time_frame>
    <description>The number of emergency room visits for the wound or the index leg, from the time the wound was identified to the time the wound heals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>up to 365 days</time_frame>
    <description>The time from when the wound is identified until the wound heals, in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputation</measure>
    <time_frame>up to 365 days</time_frame>
    <description>Major (above the ankle) or minor (toe/TMA) amputation of the index leg.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Peripheral Artery Disease</condition>
  <condition>Peripheral Vascular Diseases</condition>
  <condition>Diabetic Foot</condition>
  <condition>Diabetic Foot Ulcer</condition>
  <condition>Diabetic Foot Infection</condition>
  <condition>Diabetic Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telemedicine specialty consultation for patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard in person referral to a specialist</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemedicine specialty consultation</intervention_name>
    <description>Patients with lower extremity wounds due to peripheral artery disease and diabetes mellitus will undergo a specialty consultation with a provider through telemedicine</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with the diagnosis of a lower extremity ulcer that has been present for longer&#xD;
             than 2 weeks&#xD;
&#xD;
          -  Must be willing to complete the patient activation survey&#xD;
&#xD;
          -  Must be willing to have the study personnel call them to check in on their status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that do not have a telephone&#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>Misty D Humphries</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Misty Humphries</last_name>
    <phone>9167342028</phone>
    <email>mdhumphries@ucdavis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cameron Ylagan</last_name>
    <email>cvylagan@ucdavis.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Misty D. Humphries</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95811</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Misty D Humphries</last_name>
      <phone>916-712-7313</phone>
      <email>dzstorm.md@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Foot 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/NCT04440839
org study id: 1598596
nct id: NCT04440839
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to determine if patients with lower extremity wounds in rural
      communities who undergo specialty referral through telemedicine have expedited care compared
      to patients who are treated through standard in person referral.
This is a clustered trial where patients identified as having lower extremity ulcers with
      peripheral artery disease and diabetes are given the option to be seen by specialty care
      providers through telemedicine vs. normal standard in person referral. The study is being
      conducted in rural areas where there are no in person vascular surgery providers. The aim of
      the study is to determine if patient activation affects likelihood to use telemedicine and if
      use of telemedicine can expedite speciality care.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patients identified as having a lower extremity wound with peripheral artery disease or diabetes mellitus are offered a telemedicine consult. Patients are then followed for time to consultation, time to revascularization if needed, and time to wound healing.
primary purpose: Treatment
masking: None (Open Label)
measure: Specialty Consultation
time frame: up to 365 days
description: The time from the date the wound is identified to the date of specialist consultation, in days.
measure: Revascularization
time frame: up to 365 days
description: The time from the date the wound is identified to the procedure to evaluation or improve blood flow for the index leg, in days.
measure: Hospitalizations
time frame: up to 365 days
description: Number of hospitalizations for the index leg and wound, from the time the wound is identified to the time the wound heals.
measure: Emergency room visits
time frame: up to 365 days
description: The number of emergency room visits for the wound or the index leg, from the time the wound was identified to the time the wound heals.
measure: Wound healing
time frame: up to 365 days
description: The time from when the wound is identified until the wound heals, in days.
measure: Amputation
time frame: up to 365 days
description: Major (above the ankle) or minor (toe/TMA) amputation of the index leg.
arm group label: Intervention
arm group type: Experimental
description: Telemedicine specialty consultation for patients
arm group label: Standard Care
arm group type: No Intervention
description: Standard in person referral to a specialist
intervention type: Other
intervention name: Telemedicine specialty consultation
description: Patients with lower extremity wounds due to peripheral artery disease and diabetes mellitus will undergo a specialty consultation with a provider through telemedicine
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Misty D Humphries
role: Principal Investigator
affiliation: University of California, Davis
last name: Misty Humphries
phone: 9167342028
email: mdhumphries@ucdavis.edu
last name: Cameron Ylagan
email: cvylagan@ucdavis.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Foot
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Vascular Diseases
mesh term: Foot Ulcer
sharing ipd: No