xml: <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/NCT06026813</url>
    </required_header>
    <id_info>
      <org_study_id>STU-2022-1038</org_study_id>
      <nct_id>NCT06026813</nct_id>
    </id_info>
    <brief_title>Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers</brief_title>
    <official_title>Pressure Alternating Shoes (PAS) for Prevention of Diabetic Foot Ulcers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas Southwestern Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>The University of Texas at Arlington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Texas Southwestern Medical Center</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The project is designed to develop and test Pressure Alternating Shoes (PAS), which will&#xD;
        periodically off-load certain regions of the foot in order to prevent foot ulcers. An&#xD;
        automated dual layer insole compromised of an active pressurized actuator array in&#xD;
        combination with a passive compliant layer on top of each actuator to modulate and distribute&#xD;
        the plantar surface pressure as desired will be tested. This device will allow us to&#xD;
        simultaneously load and offload select areas of the foot using the active layer by inflating&#xD;
        and deflating individual actuators using pressurized air. After offloading, the remaining&#xD;
        load will be distributed to other areas with inflated actuators. Automatic modulation will be&#xD;
        provided through programmable control hardware which will cyclically relieve mechanical&#xD;
        loading based on a prescribed duration and frequency.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Plantar pressure</measure>
      <time_frame>Baseline</time_frame>
      <description>Plantar pressures measured by the internal air pressure of the insole (kPa or mmHg)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plantar skin temperature</measure>
      <time_frame>Baseline</time_frame>
      <description>Plantar skin temperature measured by a noncontact thermal imaging camera (*Celcius)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tissue oxygenation</measure>
      <time_frame>Baseline</time_frame>
      <description>Plantar foot tissue oxygenation measure by noncontact hyperspectral imaging camera (StO2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Balance</measure>
      <time_frame>Baseline</time_frame>
      <description>Positional sense measured by body-worn sensors (cm)</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Foot Ulcer, Diabetic</condition>
    <arm_group>
      <arm_group_label>Healthy controls</arm_group_label>
      <description>Patients without diabetes who do not have foot wounds or history of amputation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients with Diabetic Neuropathy</arm_group_label>
      <description>Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          1. Healthy controls&#xD;
  &#xD;
            2. Patients with Diabetic Neuropathy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Healthy Controls:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 or greater&#xD;
  &#xD;
            -  Ability to wear insoles in shoes provided&#xD;
  &#xD;
            -  Ability to walk unaided&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diabetic Neuropathy&#xD;
  &#xD;
            -  Charcot foot&#xD;
  &#xD;
            -  Knee pain&#xD;
  &#xD;
            -  Previous amputations&#xD;
  &#xD;
            -  Inflammatory diseases such as rheumatoid arthritis&#xD;
  &#xD;
            -  Open wounds, ulcers, sores or blisters on the feet; signs of infection in the feet&#xD;
  &#xD;
          Diabetic population:&#xD;
  &#xD;
          Inclusion:&#xD;
  &#xD;
            -  Age 18 or greater&#xD;
  &#xD;
            -  Ability to wear insoles in shoes provided&#xD;
  &#xD;
            -  Ability to walk unaided&#xD;
  &#xD;
            -  Diagnosis of diabetic neuropathy&#xD;
  &#xD;
          Excluision:&#xD;
  &#xD;
            -  Charcot foot&#xD;
  &#xD;
            -  Knee Pain&#xD;
  &#xD;
            -  Previous amputations&#xD;
  &#xD;
            -  Inflammatory diseases such as rheumatoid arthritis&#xD;
  &#xD;
            -  Open wounds, ulcers, sores or blistesr on the feet; signs of infection in the feet&#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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</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>Larry Lavery</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <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>
  
  
text: 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/NCT06026813
  org study id: STU-2022-1038
  nct id: NCT06026813
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The project is designed to develop and test Pressure Alternating Shoes (PAS), which will
        periodically off-load certain regions of the foot in order to prevent foot ulcers. An
        automated dual layer insole compromised of an active pressurized actuator array in
        combination with a passive compliant layer on top of each actuator to modulate and distribute
        the plantar surface pressure as desired will be tested. This device will allow us to
        simultaneously load and offload select areas of the foot using the active layer by inflating
        and deflating individual actuators using pressurized air. After offloading, the remaining
        load will be distributed to other areas with inflated actuators. Automatic modulation will be
        provided through programmable control hardware which will cyclically relieve mechanical
        loading based on a prescribed duration and frequency.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Plantar pressure
  time frame: Baseline
  description: Plantar pressures measured by the internal air pressure of the insole (kPa or mmHg)
  measure: Plantar skin temperature
  time frame: Baseline
  description: Plantar skin temperature measured by a noncontact thermal imaging camera (*Celcius)
  measure: Tissue oxygenation
  time frame: Baseline
  description: Plantar foot tissue oxygenation measure by noncontact hyperspectral imaging camera (StO2)
  measure: Balance
  time frame: Baseline
  description: Positional sense measured by body-worn sensors (cm)
  arm group label: Healthy controls
  description: Patients without diabetes who do not have foot wounds or history of amputation
  arm group label: Patients with Diabetic Neuropathy
  description: Patients with diagnosed diabetes and neuropathy who do not have foot wounds or history of amputation.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas Southwestern Medical Center
  investigator full name: Larry Lavery
  investigator title: Professor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Ulcer
  sharing ipd: No