<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/NCT02220881</url>
  </required_header>
  <id_info>
    <org_study_id>silicone HV</org_study_id>
    <nct_id>NCT02220881</nct_id>
  </id_info>
  <brief_title>Mold Making Silicone Toe Separator on Hallux Valgus</brief_title>
  <official_title>Effectiveness of Mold Making Silicone Toe Separator on Hallux Valgus: A Prospective, Randomized Single-Blinded Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to investigate the effectiveness of mold making&#xD;
      silicone toe separator on reducing the hallux valgus angle. In addition, this study aims to&#xD;
      determine the compliance of mold making silicone toe separator, the change in pain level and,&#xD;
      including, the satisfaction of the participants after using mold making silicone toe&#xD;
      separator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Protocol, Data collection&#xD;
&#xD;
      Ninety recruited sample is the patient come to the foot clinic, Siriraj Hospital with the age&#xD;
      over eighteen years old, presence of hallux valgus deformity in moderate level (without the&#xD;
      condition of hallux rigidus), and never use hallux valgus strap or toes separator before.&#xD;
&#xD;
      The sample is given a physical assessment by physician and is asked to fill in a&#xD;
      self-administered questionnaire which composes of general information, the foot problem&#xD;
      information and the impact of deformity to patients function information. General information&#xD;
      section requires the detail regarding age, genders, and the average walking hours. Foot&#xD;
      problem information section composes of side, duration of hallux valgus and family history.&#xD;
      Impacts of the hallux valgus deformity section includes walking problem, shoes-fitting&#xD;
      problem, working problem, and daily activities problem, were recorded by using a numeric&#xD;
      rating scale from 0 to 10; 0 refers as no problem and 10 refers as the worst problem. The&#xD;
      sample then will be taken the radiograph of the feet in order to evaluate the degree of&#xD;
      hallux valgus angle and intermetatarsal angle.&#xD;
&#xD;
      After the completion of assessment, the sample is randomly divided into 2 groups; control and&#xD;
      experimental group by using computer program.&#xD;
&#xD;
        -  Control group receives the recommendation of use the proper shoes without determination&#xD;
           of current drug use&#xD;
&#xD;
        -  Experimental group receives the custom-made mold making silicone toe separator made by&#xD;
           certified orthotist and the recommendation of use the proper shoes without determination&#xD;
           of current drug use&#xD;
&#xD;
      The follow up activity is on every 3rd, 6th, 9th and 12th of the study period in both groups&#xD;
      by using questionnaire; pain score (NRS), satisfaction of using the custom-made mold making&#xD;
      silicone toe separator (NRS) and report of complication. In the 6th and 12th month, the&#xD;
      progress evaluation on hallux valgus and intermetatarsal angle is done by radiograph. The&#xD;
      angle then is recorded by mean of the three values.&#xD;
&#xD;
      Descriptive statistics; mean, standard deviation or interquartile range, will be used to&#xD;
      identify the demographic data of the participant and compliance of device usage. Analytical&#xD;
      statistics; Unpaired t-test or Mann Whitney U test will be used for determining the average&#xD;
      device usage time, pain score, and satisfaction of the participants after using mold making&#xD;
      silicone toe separator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of degree of Hallux valgus angle at month 6 ans month 12</measure>
    <time_frame>Baseline, month 6, month 12</time_frame>
    <description>Hallux valgus angle will be measured from the x-ray film taken in standing position with full weight bearing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of degree of intermetatarsal angle at month 6 ans month 12</measure>
    <time_frame>Baseline, month 6, month 12</time_frame>
    <description>Intermetatarsal angle will be measured from the x-ray film taken in standing position with full weight bearing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in pain score on 11-point Visual Analog Scale at month 3, month 6, month 9 and month 12</measure>
    <time_frame>Baseline, month 3, month 6, month 9 and month 12</time_frame>
    <description>To measure the pain score of the hallux by using the numeric rating scale in the 3rd, 6th, 9th and 12th month</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Compliance of using Mold Making Silicone Toe Separator</measure>
    <time_frame>Baseline, month 3, month 6, month 9 and month 12</time_frame>
    <description>To identify the compliance by questionnaire in the 6th and 12th month, and self report (diary)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Hallux Valgus</condition>
  <arm_group>
    <arm_group_label>Mold making silicone toe separator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subject in experimental group will use mold making silicone toe separator everyday</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This group will follow the physician instruction of care for the hallux valgus</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mold making silicone toe separator</intervention_name>
    <description>Each subject in the controlled receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use</description>
    <arm_group_label>Mold making silicone toe separator</arm_group_label>
    <other_name>Toe separator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>The participants in this groups will be educated on how to care the hallux valgus without any intervention. The follow up will be on the 3rd, 6th, 9th and 12th month.</description>
    <arm_group_label>Observation</arm_group_label>
    <other_name>Control group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  More than 18 years of age&#xD;
&#xD;
          -  Presence of hallux valgus deformity in moderate level, if the condition presents in&#xD;
             both side, the one with greater angle will be selected&#xD;
&#xD;
          -  Never use hallux valgus strap or toes separator before&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of hallux rigidus and hallux limitus&#xD;
&#xD;
          -  Presence of acute hallux inflammation&#xD;
&#xD;
          -  Experience the use hallux valgus strap or toes separator in a past year&#xD;
&#xD;
          -  Experience the allergy to silicone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Navaporn Chadchavalpanichaya, MD, C.Ped</last_name>
    <email>drnavaporn@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sirirat Sengiad, BSc, MA</last_name>
    <email>siriratseng@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine Siriraj Hospital</name>
      <address>
        <city>Bangkok-noi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Navaporn Chadchavalpanichaya, MD, C.Ped</last_name>
      <email>drnavaporn@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sirirat Sengiad, BSc, MA</last_name>
      <email>siriratseng@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Navaporn Chadchavalpanichaya, MD, CPed</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>January 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Navaporn Chadchavalpanichaya</investigator_full_name>
    <investigator_title>Assistance Professor</investigator_title>
  </responsible_party>
  <keyword>Hallux valgus, Mold making silicone toe separator, Toe separator</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallux Valgus</mesh_term>
    <mesh_term>Bunion</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>March 28, 2017</submitted>
    <returned>June 14, 2017</returned>
    <submitted>July 13, 2017</submitted>
    <returned>January 31, 2018</returned>
  </pending_results>
  <!-- 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/NCT02220881
org study id: silicone HV
nct id: NCT02220881
lead sponsor: 
has dmc: No
The primary objective of this study is to investigate the effectiveness of mold making
      silicone toe separator on reducing the hallux valgus angle. In addition, this study aims to
      determine the compliance of mold making silicone toe separator, the change in pain level and,
      including, the satisfaction of the participants after using mold making silicone toe
      separator.
Study Protocol, Data collection

      Ninety recruited sample is the patient come to the foot clinic, Siriraj Hospital with the age
      over eighteen years old, presence of hallux valgus deformity in moderate level (without the
      condition of hallux rigidus), and never use hallux valgus strap or toes separator before.

      The sample is given a physical assessment by physician and is asked to fill in a
      self-administered questionnaire which composes of general information, the foot problem
      information and the impact of deformity to patients function information. General information
      section requires the detail regarding age, genders, and the average walking hours. Foot
      problem information section composes of side, duration of hallux valgus and family history.
      Impacts of the hallux valgus deformity section includes walking problem, shoes-fitting
      problem, working problem, and daily activities problem, were recorded by using a numeric
      rating scale from 0 to 10; 0 refers as no problem and 10 refers as the worst problem. The
      sample then will be taken the radiograph of the feet in order to evaluate the degree of
      hallux valgus angle and intermetatarsal angle.

      After the completion of assessment, the sample is randomly divided into 2 groups; control and
      experimental group by using computer program.

        -  Control group receives the recommendation of use the proper shoes without determination
           of current drug use

        -  Experimental group receives the custom-made mold making silicone toe separator made by
           certified orthotist and the recommendation of use the proper shoes without determination
           of current drug use

      The follow up activity is on every 3rd, 6th, 9th and 12th of the study period in both groups
      by using questionnaire; pain score (NRS), satisfaction of using the custom-made mold making
      silicone toe separator (NRS) and report of complication. In the 6th and 12th month, the
      progress evaluation on hallux valgus and intermetatarsal angle is done by radiograph. The
      angle then is recorded by mean of the three values.

      Descriptive statistics; mean, standard deviation or interquartile range, will be used to
      identify the demographic data of the participant and compliance of device usage. Analytical
      statistics; Unpaired t-test or Mann Whitney U test will be used for determining the average
      device usage time, pain score, and satisfaction of the participants after using mold making
      silicone toe separator.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline of degree of Hallux valgus angle at month 6 ans month 12
time frame: Baseline, month 6, month 12
description: Hallux valgus angle will be measured from the x-ray film taken in standing position with full weight bearing
measure: Change from baseline of degree of intermetatarsal angle at month 6 ans month 12
time frame: Baseline, month 6, month 12
description: Intermetatarsal angle will be measured from the x-ray film taken in standing position with full weight bearing
measure: Change from baseline in pain score on 11-point Visual Analog Scale at month 3, month 6, month 9 and month 12
time frame: Baseline, month 3, month 6, month 9 and month 12
description: To measure the pain score of the hallux by using the numeric rating scale in the 3rd, 6th, 9th and 12th month
measure: Compliance of using Mold Making Silicone Toe Separator
time frame: Baseline, month 3, month 6, month 9 and month 12
description: To identify the compliance by questionnaire in the 6th and 12th month, and self report (diary)
arm group label: Mold making silicone toe separator
arm group type: Experimental
description: The subject in experimental group will use mold making silicone toe separator everyday
arm group label: Observation
arm group type: Other
description: This group will follow the physician instruction of care for the hallux valgus
intervention type: Device
intervention name: Mold making silicone toe separator
description: Each subject in the controlled receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use
arm group label: Mold making silicone toe separator
other name: Toe separator
intervention type: Other
intervention name: Observation
description: The participants in this groups will be educated on how to care the hallux valgus without any intervention. The follow up will be on the 3rd, 6th, 9th and 12th month.
arm group label: Observation
other name: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Navaporn Chadchavalpanichaya, MD, C.Ped
email: drnavaporn@gmail.com
last name: Sirirat Sengiad, BSc, MA
email: siriratseng@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Navaporn Chadchavalpanichaya
investigator title: Assistance Professor
mesh term: Hallux Valgus
mesh term: Bunion
submitted: March 28, 2017
returned: June 14, 2017
submitted: July 13, 2017
returned: January 31, 2018