<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/NCT03827902</url>
  </required_header>
  <id_info>
    <org_study_id>STU 042018-008</org_study_id>
    <nct_id>NCT03827902</nct_id>
  </id_info>
  <brief_title>Diabetic Foot Ulcer and Wound Infection</brief_title>
  <official_title>Remote Glycemic Management for Patients With Diabetic Foot Ulcer and Wound Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parkland Health and Hospital System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the study is to compare whether an integrated model of care between Foot Wound&#xD;
      and Diabetes Clinic with use of remote glucose monitoring technology (Intervention Arm), as&#xD;
      compared with usual care without the use of remote glucose monitoring technology (Control&#xD;
      Arm), will result in 1) improved glycemic control, 2) improved ulcer and wound healing, 3)&#xD;
      improved patient reported outcomes (PROs), 4) reduced long-term healthcare resource&#xD;
      utilization, and 5) improved adherence to anti-glycemic therapy for patients with DFUWI and&#xD;
      poor glycemic control over the course of a 6-month intervention period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-arm non-randomized convenient pilot trial to assess impact of an active&#xD;
      glycemic management model through remote glucose monitoring technology amongst patients with&#xD;
      DFUWI and poor glycemic control at the Parkland Diabetes Foot &amp; Wound clinic. The plan is to&#xD;
      implement a remote glucose monitoring technology to facilitate improved glycemic management&#xD;
      and control. A cellular enabled glucose meter that will upload blood glucose measurements to&#xD;
      a cloud server accessible by providers who can remotely review glycemic trends and remotely&#xD;
      provide patients with proactive recommendations for treatment adjustments will be used.&#xD;
      Patients receiving services in the integrated care model (same day visits in the Foot Wound&#xD;
      and Diabetes Clinics at Parkland) will be eligible for inclusion in the intervention arm&#xD;
      which includes proactive glucose monitoring guided by remote glucose monitoring technology.&#xD;
      Patients receiving usual care services (non-integrated care model clinic days where Foot&#xD;
      Wound and Diabetes Clinic visits are on separate days) will be eligible for inclusion in the&#xD;
      control arm. The expectation is that patients in the intervention arm will experience greater&#xD;
      improvements in glycemic control, compared to the usual care model. The hypothesis is that&#xD;
      improved glycemic control in these patients will result in faster healing of diabetic foot&#xD;
      wound, infections or ulcers. The effectiveness of the technologically facilitated integrated&#xD;
      model of care will be evaluated compared to the usual care using metrics for diabetic foot&#xD;
      ulcers and wound healing, glycemic control, patient reported outcomes, health resource&#xD;
      utilization and medication adherence after 6 months of intervention. The Telcare 2.0 BGM for&#xD;
      remote self-blood glucose monitoring(FDA Cleared) will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to recruit participants&#xD;
  </why_stopped>
  <start_date type="Actual">July 9, 2019</start_date>
  <completion_date type="Actual">April 2, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>6 months</time_frame>
    <description>Mean change in HbA1c from baseline to end of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of patients with lower A1C and insulin use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot ulcer and/or wound healing</measure>
    <time_frame>6 months</time_frame>
    <description>Complete wound healing as defined by University of Texas Health System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported satisfaction with diabetes treatment</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported outcome assessment questionnaire using the Diabetes Treatment Satisfcation Questionnaire (DTSQ) [Scale range 0-48]; lower scores represent worse outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported health status</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported outcome assessment questionnaires using the 5 level EQ-5D health status measure (EQ-5D-5L) [Scale range 5-25]; higher scores represent worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with emergency department visits</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of patients with emergency department visits following enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of days covered score</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of days covered score represents an indirect measure of medication adherence and represents the proportion of days medication was dispensed (numerator) over the total potential days the medication should have been dispensed (denominator)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with hospitalization</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of patients with hospitalization following enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of invasive procedures</measure>
    <time_frame>6 months</time_frame>
    <description>Total number and type of invasive procedures related to diabetic foot ulcer and or wound infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of outpatient visits</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of outpatient visits for general or specialized care (including virtual visits) during trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of casts and boots used for treatment</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of casts and boots used for treatment related to diabetic foot ulcer and or wound infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall hospital incurred patient-specific cost</measure>
    <time_frame>6 months</time_frame>
    <description>Cost (in US $) of overall patient care for Parkland during study enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of glycemic management during study</measure>
    <time_frame>6 months</time_frame>
    <description>• Cost of glycemic management during trial, including cost of encounters (including telephone and virtual visits), testing supplies, drug costs, technology costs specifically related to glycemic management</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Frequency of hypoglycemic events</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison of frequency of severe hypoglycemic symptoms for usual care versus intervention arm</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes Complications</condition>
  <condition>Diabetes</condition>
  <condition>Diabetic Foot Ulcer</condition>
  <condition>Wound Infection</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <description>A Telcare 2.0 BGM, which is FDA cleared, will be used to upload blood glucose measurements to a cloud server accessible by providers. Intervention group will participate in an integrated care model where they will attend Diabetic Clinic and Foot Wound appointments on the same day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Control Group will receive usual care (a non-integrated care model where Diabetes Clinic and Foot Wound appointments are on separate days.) These patients will not receive a blood monitoring glucose device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telcare 2.0 BGM</intervention_name>
    <description>Blood glucose meter that uploads blood glucose measurements to a cloud server that providers can access and use to monitor patients' glycemic trends.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diabetic foot ulcer &amp;/or wound infection and poor glycemic control (A1C ≥&#xD;
        8.5%) seen in the Foot Wound clinic at a public hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 Diabetes&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  A1C greater than or equal to 8.5% within the preceding 6 months&#xD;
&#xD;
          -  A1C greater than 8% on day of enrollment&#xD;
&#xD;
          -  Active diabetic foot ulcer or wound receiving treatment in the Foot Wound clinic at&#xD;
             Parkland (ulcer that meets University of Texas Classification Grade 1 or 2 of any&#xD;
             stage)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic osteomyelitis (even if completed active therapy)&#xD;
&#xD;
          -  Moderate/severe lower limb infection (per Infectious Diseases Society of America&#xD;
             criteria)&#xD;
&#xD;
          -  Diabetic Foot Ulcer and Wound Infection on Charcot Foot&#xD;
&#xD;
          -  Any serious/unstable medical condition that interferes with treatment assignment&#xD;
&#xD;
          -  Ankle Brachial Index less than 0.7 or toe pressures less than 30mmHg&#xD;
&#xD;
          -  Unwilling to participate or receive injectable treatment or unable to keep&#xD;
             appointments&#xD;
&#xD;
          -  Non-English or Non-Spanish speakers&#xD;
&#xD;
          -  Pregnant or planning to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uma Gunasekaran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkland Health and Hospital System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Uma Gunasekaran</investigator_full_name>
    <investigator_title>Assistant Professor, Internal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Complications</mesh_term>
    <mesh_term>Ulcer</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03827902
org study id: STU 042018-008
nct id: NCT03827902
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The goal of the study is to compare whether an integrated model of care between Foot Wound
      and Diabetes Clinic with use of remote glucose monitoring technology (Intervention Arm), as
      compared with usual care without the use of remote glucose monitoring technology (Control
      Arm), will result in 1) improved glycemic control, 2) improved ulcer and wound healing, 3)
      improved patient reported outcomes (PROs), 4) reduced long-term healthcare resource
      utilization, and 5) improved adherence to anti-glycemic therapy for patients with DFUWI and
      poor glycemic control over the course of a 6-month intervention period.
This is a two-arm non-randomized convenient pilot trial to assess impact of an active
      glycemic management model through remote glucose monitoring technology amongst patients with
      DFUWI and poor glycemic control at the Parkland Diabetes Foot & Wound clinic. The plan is to
      implement a remote glucose monitoring technology to facilitate improved glycemic management
      and control. A cellular enabled glucose meter that will upload blood glucose measurements to
      a cloud server accessible by providers who can remotely review glycemic trends and remotely
      provide patients with proactive recommendations for treatment adjustments will be used.
      Patients receiving services in the integrated care model (same day visits in the Foot Wound
      and Diabetes Clinics at Parkland) will be eligible for inclusion in the intervention arm
      which includes proactive glucose monitoring guided by remote glucose monitoring technology.
      Patients receiving usual care services (non-integrated care model clinic days where Foot
      Wound and Diabetes Clinic visits are on separate days) will be eligible for inclusion in the
      control arm. The expectation is that patients in the intervention arm will experience greater
      improvements in glycemic control, compared to the usual care model. The hypothesis is that
      improved glycemic control in these patients will result in faster healing of diabetic foot
      wound, infections or ulcers. The effectiveness of the technologically facilitated integrated
      model of care will be evaluated compared to the usual care using metrics for diabetic foot
      ulcers and wound healing, glycemic control, patient reported outcomes, health resource
      utilization and medication adherence after 6 months of intervention. The Telcare 2.0 BGM for
      remote self-blood glucose monitoring(FDA Cleared) will be used.
observational model: Case-Control
time perspective: Prospective
measure: Change in HbA1c
time frame: 6 months
description: Mean change in HbA1c from baseline to end of treatment
measure: Glycemic control
time frame: 6 months
description: Proportion of patients with lower A1C and insulin use
measure: Foot ulcer and/or wound healing
time frame: 6 months
description: Complete wound healing as defined by University of Texas Health System
measure: Patient reported satisfaction with diabetes treatment
time frame: 6 months
description: Self-reported outcome assessment questionnaire using the Diabetes Treatment Satisfcation Questionnaire (DTSQ) [Scale range 0-48]; lower scores represent worse outcomes
measure: Patient reported health status
time frame: 6 months
description: Self-reported outcome assessment questionnaires using the 5 level EQ-5D health status measure (EQ-5D-5L) [Scale range 5-25]; higher scores represent worse outcome
measure: Proportion of patients with emergency department visits
time frame: 6 months
description: Proportion of patients with emergency department visits following enrollment
measure: Proportion of days covered score
time frame: 6 months
description: Proportion of days covered score represents an indirect measure of medication adherence and represents the proportion of days medication was dispensed (numerator) over the total potential days the medication should have been dispensed (denominator)
measure: Proportion of patients with hospitalization
time frame: 6 months
description: Proportion of patients with hospitalization following enrollment
measure: Frequency of invasive procedures
time frame: 6 months
description: Total number and type of invasive procedures related to diabetic foot ulcer and or wound infection
measure: Number of outpatient visits
time frame: 6 months
description: Total number of outpatient visits for general or specialized care (including virtual visits) during trial
measure: Number of casts and boots used for treatment
time frame: 6 months
description: Total number of casts and boots used for treatment related to diabetic foot ulcer and or wound infection
measure: Overall hospital incurred patient-specific cost
time frame: 6 months
description: Cost (in US $) of overall patient care for Parkland during study enrollment
measure: Cost of glycemic management during study
time frame: 6 months
description: • Cost of glycemic management during trial, including cost of encounters (including telephone and virtual visits), testing supplies, drug costs, technology costs specifically related to glycemic management
measure: Frequency of hypoglycemic events
time frame: 6 months
description: Comparison of frequency of severe hypoglycemic symptoms for usual care versus intervention arm
arm group label: Intervention Group
description: A Telcare 2.0 BGM, which is FDA cleared, will be used to upload blood glucose measurements to a cloud server accessible by providers. Intervention group will participate in an integrated care model where they will attend Diabetic Clinic and Foot Wound appointments on the same day.
arm group label: Control Group
description: Control Group will receive usual care (a non-integrated care model where Diabetes Clinic and Foot Wound appointments are on separate days.) These patients will not receive a blood monitoring glucose device.
intervention type: Device
intervention name: Telcare 2.0 BGM
description: Blood glucose meter that uploads blood glucose measurements to a cloud server that providers can access and use to monitor patients' glycemic trends.
arm group label: Intervention Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Uma Gunasekaran, MD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Uma Gunasekaran
investigator title: Assistant Professor, Internal Medicine
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Wound Infection
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Diabetes Mellitus
mesh term: Diabetes Complications
mesh term: Ulcer
mesh term: Wounds and Injuries
sharing ipd: No