<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/NCT02233140</url>
  </required_header>
  <id_info>
    <org_study_id>21660</org_study_id>
    <nct_id>NCT02233140</nct_id>
  </id_info>
  <brief_title>Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure</brief_title>
  <official_title>Do Physical Manipulation Exercises With EPAT Improve Ankle Dorsiflexion and Reduce Dynamic Plantar Forefoot Pressure in Diabetic Subjects With Equinus?: A Pilot RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic foot complications are a common and costly problem. Excessive plantar pressures due&#xD;
      to foot deformities and/or limited ankle dorsiflexion, especially in the presence of&#xD;
      peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers.&#xD;
      Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot&#xD;
      ulcers.&#xD;
&#xD;
      Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology)&#xD;
      was effective in treating subjects with chronic heel pain and Achilles tendonitis with no&#xD;
      serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to&#xD;
      perform more effective stretching exercises and may prevent recurrence of diabetic foot&#xD;
      ulcers.&#xD;
&#xD;
      The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus&#xD;
      manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk&#xD;
      subjects with a history of diabetic foot ulcer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks</measure>
    <time_frame>at baseline visit and at 4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.</measure>
    <time_frame>at baseline visit and 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.</measure>
    <time_frame>at 1 month and at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months.</measure>
    <time_frame>at 1 month and at 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Diabetes</condition>
  <condition>Equinus Contracture of the Ankle</condition>
  <arm_group>
    <arm_group_label>Shockwave with manual manipulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A shockwave (EPAT) therapy with two supervised manual manipulation per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual manipulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A Placebo (no) shockwave with two supervised manual manipulations per week</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Extra-corporeal pulsed-activated therapy or shockwave therapy</intervention_name>
    <arm_group_label>Manual manipulation</arm_group_label>
    <arm_group_label>Shockwave with manual manipulation</arm_group_label>
    <other_name>D-Actor® 200</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women between the ages of 21 to 65, inclusive&#xD;
&#xD;
          -  Diabetes, either type 1 or 2&#xD;
&#xD;
          -  Ankle equinus (&lt; 0º passive ankle dorsiflexion with knee extended)&#xD;
&#xD;
          -  Forefoot plantar hyperkeratosis (callus)&#xD;
&#xD;
          -  Able to walk independently without the use of walking aids (cane, crutches, or walker)&#xD;
&#xD;
          -  Able to understand the information in the informed consent form and willing and able&#xD;
             to comply with study-related procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of ankle-foot surgery or amputation&#xD;
&#xD;
          -  no active lower extremity skin ulcers&#xD;
&#xD;
          -  Peripheral vascular disease (non-palpable pedal pulses or ankle brachial index &lt;0.8)&#xD;
&#xD;
          -  Not willing or able to make required visits&#xD;
&#xD;
          -  Nursing or pregnant&#xD;
&#xD;
          -  Not willing or able to follow procedures specified by protocol and/or instructions of&#xD;
             the study personnel, including discontinuation of icing, NSAIDs and natural&#xD;
             anti-inflammatory agents (such as Arnica)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinsup Song, DPM, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jinsup Song, D.P.M., Ph.D.</last_name>
    <phone>215-625-5369</phone>
    <email>jsong@temple.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gait Study Center at the Temple University School of Podiatric Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinsup Song, D.P.M., Ph.D.</last_name>
      <phone>215-625-5369</phone>
      <email>jsong@temple.edu</email>
    </contact>
    <investigator>
      <last_name>Jinsup Song, D.P.M., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>August 26, 2015</last_update_submitted>
  <last_update_submitted_qc>August 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Ankle equinus</keyword>
  <keyword>ankle dorsiflexion</keyword>
  <keyword>dynamic plantar pressure</keyword>
  <keyword>shockwave therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contracture</mesh_term>
    <mesh_term>Equinus Deformity</mesh_term>
    <mesh_term>Talipes</mesh_term>
    <mesh_term>Clubfoot</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/NCT02233140
org study id: 21660
nct id: NCT02233140
lead sponsor: 
has dmc: No
Diabetic foot complications are a common and costly problem. Excessive plantar pressures due
      to foot deformities and/or limited ankle dorsiflexion, especially in the presence of
      peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers.
      Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot
      ulcers.

      Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology)
      was effective in treating subjects with chronic heel pain and Achilles tendonitis with no
      serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to
      perform more effective stretching exercises and may prevent recurrence of diabetic foot
      ulcers.

      The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus
      manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk
      subjects with a history of diabetic foot ulcer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
time frame: at baseline visit and at 4 weeks
measure: Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.
time frame: at baseline visit and 4 weeks
measure: Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.
time frame: at 1 month and at 3 months
measure: Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months.
time frame: at 1 month and at 3 months
arm group label: Shockwave with manual manipulation
arm group type: Experimental
description: A shockwave (EPAT) therapy with two supervised manual manipulation per week
arm group label: Manual manipulation
arm group type: Active Comparator
description: A Placebo (no) shockwave with two supervised manual manipulations per week
intervention type: Device
intervention name: Extra-corporeal pulsed-activated therapy or shockwave therapy
arm group label: Manual manipulation
arm group label: Shockwave with manual manipulation
other name: D-Actor® 200
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jinsup Song, DPM, PhD
role: Principal Investigator
affiliation: Temple University
last name: Jinsup Song, D.P.M., Ph.D.
phone: 215-625-5369
email: jsong@temple.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Contracture
mesh term: Equinus Deformity
mesh term: Talipes
mesh term: Clubfoot