<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/NCT01699100</url>
  </required_header>
  <id_info>
    <org_study_id>SF11024</org_study_id>
    <nct_id>NCT01699100</nct_id>
  </id_info>
  <brief_title>Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Insoles With Removable Pegs Design</brief_title>
  <official_title>Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Offloading Technique: Insoles With Peg Assist Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to determine if insoles with removable pegs could effectively&#xD;
      reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for&#xD;
      guidance of peg removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators tested the effect of plantar pressure reduction in four conditions:&#xD;
&#xD;
        1. insole of the original shoe&#xD;
&#xD;
        2. peg assist insole but the pegs are not yet removed&#xD;
&#xD;
        3. peg assist insole and the pegs were removed&#xD;
&#xD;
        4. condition3. plus arch support to the insole&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>plantar pressure of region of interest</measure>
    <time_frame>30 minutes</time_frame>
    <description>In-shoe plantar pressure difference between before and after insole use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plantar pressure of non-region of interest</measure>
    <time_frame>30 minutes</time_frame>
    <description>In-shoe plantar pressure difference between before and after insole use.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>plantar pressure of midfoot area</measure>
    <time_frame>30 minutes</time_frame>
    <description>In-shoe plantar pressure difference between before and after insole use.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Foot Ulcer, Diabetic</condition>
  <arm_group>
    <arm_group_label>device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In-shoe plantar pressure measurements were performed in 26 patients with diabetic neuropathic feet at baseline condition, and 52 regions of interest (ROIs, with mean peak pressure &gt; 200kPa or with the highest mean peak pressure in the forefoot area) were identified as suitable areas for removal of pegs. Data of in-shoe plantar pressures of the three insole conditions (pre-peg removal, post-peg removal, and post-peg removal plus arch support) were collected. Mean peak pressure (MPP) and pressure-time integral (PTI) were recorded for analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>device</intervention_name>
    <description>Experimental: insole In-shoe plantar pressure measurements were performed in 26 patients with diabetic neuropathic feet at baseline condition, and 52 regions of interest (ROIs, with mean peak pressure &gt; 200kPa or with the highest mean peak pressure in the forefoot area) were identified as suitable areas for removal of pegs. Data of in-shoe plantar pressures of the three insole conditions (pre-peg removal, post-peg removal, and post-peg removal plus arch support) were collected. Mean peak pressure (MPP) and pressure-time integral (PTI) were recorded for analysis.</description>
    <arm_group_label>device</arm_group_label>
    <other_name>Insoles from Dr.Foot Technology</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  previously diagnosed type 2 diabetes with neuropathic foot were recruited from the&#xD;
             outpatient endocrinology and metabolism division of Taichung Veterans General Hospital&#xD;
             in central Taiwan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria were history of lower extremities amputation, major foot&#xD;
             deformities, presence of active plantar foot wound or ulcer, and difficulty walking&#xD;
             more than 100 m.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tung-Liang Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Verterans General Hospital</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taichung Veterans General Hospital</investigator_affiliation>
    <investigator_full_name>Tung-Liang,Lin</investigator_full_name>
    <investigator_title>Taichung Veterans General Hospital</investigator_title>
  </responsible_party>
  <keyword>offloading</keyword>
  <keyword>plantar pressure</keyword>
  <keyword>insole</keyword>
  <keyword>foot ulcer</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>
  </condition_browse>
  <!-- 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/NCT01699100
org study id: SF11024
nct id: NCT01699100
lead sponsor: 
has dmc: Yes
The purpose of this study was to determine if insoles with removable pegs could effectively
      reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for
      guidance of peg removal.
The investigators tested the effect of plantar pressure reduction in four conditions:

        1. insole of the original shoe

        2. peg assist insole but the pegs are not yet removed

        3. peg assist insole and the pegs were removed

        4. condition3. plus arch support to the insole
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: plantar pressure of region of interest
time frame: 30 minutes
description: In-shoe plantar pressure difference between before and after insole use.
measure: Plantar pressure of non-region of interest
time frame: 30 minutes
description: In-shoe plantar pressure difference between before and after insole use.
measure: plantar pressure of midfoot area
time frame: 30 minutes
description: In-shoe plantar pressure difference between before and after insole use.
arm group label: device
arm group type: Experimental
description: In-shoe plantar pressure measurements were performed in 26 patients with diabetic neuropathic feet at baseline condition, and 52 regions of interest (ROIs, with mean peak pressure > 200kPa or with the highest mean peak pressure in the forefoot area) were identified as suitable areas for removal of pegs. Data of in-shoe plantar pressures of the three insole conditions (pre-peg removal, post-peg removal, and post-peg removal plus arch support) were collected. Mean peak pressure (MPP) and pressure-time integral (PTI) were recorded for analysis.
intervention type: Other
intervention name: device
description: Experimental: insole In-shoe plantar pressure measurements were performed in 26 patients with diabetic neuropathic feet at baseline condition, and 52 regions of interest (ROIs, with mean peak pressure > 200kPa or with the highest mean peak pressure in the forefoot area) were identified as suitable areas for removal of pegs. Data of in-shoe plantar pressures of the three insole conditions (pre-peg removal, post-peg removal, and post-peg removal plus arch support) were collected. Mean peak pressure (MPP) and pressure-time integral (PTI) were recorded for analysis.
arm group label: device
other name: Insoles from Dr.Foot Technology
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tung-Liang Lin, MD
role: Principal Investigator
affiliation: Taichung Verterans General Hospital
responsible party type: Principal Investigator
investigator affiliation: Taichung Veterans General Hospital
investigator full name: Tung-Liang,Lin
investigator title: Taichung Veterans General Hospital
mesh term: Diabetic Foot
mesh term: Foot Ulcer