<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/NCT03008629</url>
  </required_header>
  <id_info>
    <org_study_id>N201610005</org_study_id>
    <nct_id>NCT03008629</nct_id>
  </id_info>
  <brief_title>Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails</brief_title>
  <official_title>Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University WanFang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Ingrown toenails are one of the most frequent nail disorders and can be treated&#xD;
      with conservative or surgical approaches. Although discovered a long time ago, the available&#xD;
      data are still very limited on the potential effectiveness of nail braces for ingrown toenail&#xD;
      treatment.&#xD;
&#xD;
      Objective: This study aimed to evaluate the efficacy of nail brace (combiped and podofix) for&#xD;
      treatment of ingrown toenails.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Method: Participants with ingrown toenail and &gt;= 12 years old with total 40 ingrown toenails&#xD;
      were included. Investigators divide patients to 3 group: (1) combiped group: Participants&#xD;
      with non-infected or mild infected ingrown nail, combiped nail brace was applied instantly.20&#xD;
      patients(2) combine combiped and podofix group: Participants with severe paronychia with&#xD;
      pyogenic granuloma, oral analgesics and antibiotics were prescribed first and nail brace was&#xD;
      applied 1 week later. Depends on disease condition, investigators applied 1-2 combiped nail&#xD;
      brace. If the pyogenic granuloma is not resolved after 1 week, investigators applied podofix&#xD;
      first for 2-4 weeks and then combiped nail brace. After the nail brace applied, participants&#xD;
      must come back between 2-4 weeks depends on disease condition.10 patients (3) podofix group:&#xD;
      participants who are afraid of combiped implantation, or with mild recurrence will be applied&#xD;
      with podofix.&#xD;
&#xD;
      Participants come back every month for evaluation and photography. Physician global&#xD;
      assessment (0-6),Patient global assessment (VAS 0-10), Treatment satisfaction (VAS 0-10), and&#xD;
      questionnaire were evaluated 1 month, 3 months and 6 months after the device applied.&#xD;
      Participants need to be followed for recurrence at 3rd month and 6th month after removed the&#xD;
      nail brace.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement (change) by Physician global assessment (0-6)</measure>
    <time_frame>1 month, 3 months and 6 months after the device applied</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain score (VAS0-10)</measure>
    <time_frame>1 month, 3 months and 6 months after the device applied</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement (change) by Patient global assessment (VAS 0-10)</measure>
    <time_frame>1 month, 3 months and 6 months after the device applied</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction (VAS 0-10)</measure>
    <time_frame>1 month, 3 months and 6 months after the device applied</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life by Questionnaire</measure>
    <time_frame>1 month, 3 months and 6 months after the device applied</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Ingrown Nail</condition>
  <arm_group>
    <arm_group_label>Podofix nail brace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for mild ingrown toenails</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combiped nail brace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for Severe dystrophic ingrown toenails</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Podofix and then Combiped nail brace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for Ingrown toenails with pyogenic granuloma</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Podofix nail brace</intervention_name>
    <description>Podofix nail brace</description>
    <arm_group_label>Podofix nail brace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Combiped nail brace</intervention_name>
    <description>Combiped nail brace</description>
    <arm_group_label>Combiped nail brace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Podofix and then Combiped nail brace</intervention_name>
    <description>Podofix and then Combiped nail brace</description>
    <arm_group_label>Podofix and then Combiped nail brace</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  more or equal to 12 years old patient with ingrown toenail&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 12 years old&#xD;
&#xD;
          -  under other nail bracing use&#xD;
&#xD;
          -  received partial nail resection within recent 2 months&#xD;
&#xD;
          -  psoriatic nail&#xD;
&#xD;
          -  target therapy related paronychia&#xD;
&#xD;
          -  received combiped or podofix previously and removed within recent 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu Chen Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University WanFang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yu Chen Huang, MD</last_name>
    <phone>886970746772</phone>
    <email>dhist2002@yahoo.com.tw</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University WanFang Hospital</investigator_affiliation>
    <investigator_full_name>Huang Yu Chen</investigator_full_name>
    <investigator_title>Attending physician of Dermatology Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nails, Ingrown</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/NCT03008629
org study id: N201610005
nct id: NCT03008629
lead sponsor: 
has dmc: No
Background: Ingrown toenails are one of the most frequent nail disorders and can be treated
      with conservative or surgical approaches. Although discovered a long time ago, the available
      data are still very limited on the potential effectiveness of nail braces for ingrown toenail
      treatment.

      Objective: This study aimed to evaluate the efficacy of nail brace (combiped and podofix) for
      treatment of ingrown toenails.
Method: Participants with ingrown toenail and >= 12 years old with total 40 ingrown toenails
      were included. Investigators divide patients to 3 group: (1) combiped group: Participants
      with non-infected or mild infected ingrown nail, combiped nail brace was applied instantly.20
      patients(2) combine combiped and podofix group: Participants with severe paronychia with
      pyogenic granuloma, oral analgesics and antibiotics were prescribed first and nail brace was
      applied 1 week later. Depends on disease condition, investigators applied 1-2 combiped nail
      brace. If the pyogenic granuloma is not resolved after 1 week, investigators applied podofix
      first for 2-4 weeks and then combiped nail brace. After the nail brace applied, participants
      must come back between 2-4 weeks depends on disease condition.10 patients (3) podofix group:
      participants who are afraid of combiped implantation, or with mild recurrence will be applied
      with podofix.

      Participants come back every month for evaluation and photography. Physician global
      assessment (0-6),Patient global assessment (VAS 0-10), Treatment satisfaction (VAS 0-10), and
      questionnaire were evaluated 1 month, 3 months and 6 months after the device applied.
      Participants need to be followed for recurrence at 3rd month and 6th month after removed the
      nail brace.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement (change) by Physician global assessment (0-6)
time frame: 1 month, 3 months and 6 months after the device applied
measure: Pain score (VAS0-10)
time frame: 1 month, 3 months and 6 months after the device applied
measure: Improvement (change) by Patient global assessment (VAS 0-10)
time frame: 1 month, 3 months and 6 months after the device applied
measure: Treatment satisfaction (VAS 0-10)
time frame: 1 month, 3 months and 6 months after the device applied
measure: Quality of life by Questionnaire
time frame: 1 month, 3 months and 6 months after the device applied
arm group label: Podofix nail brace
arm group type: Experimental
description: for mild ingrown toenails
arm group label: Combiped nail brace
arm group type: Experimental
description: for Severe dystrophic ingrown toenails
arm group label: Podofix and then Combiped nail brace
arm group type: Experimental
description: for Ingrown toenails with pyogenic granuloma
intervention type: Device
intervention name: Podofix nail brace
description: Podofix nail brace
arm group label: Podofix nail brace
intervention type: Device
intervention name: Combiped nail brace
description: Combiped nail brace
arm group label: Combiped nail brace
intervention type: Device
intervention name: Podofix and then Combiped nail brace
description: Podofix and then Combiped nail brace
arm group label: Podofix and then Combiped nail brace
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Yu Chen Huang, MD
role: Principal Investigator
affiliation: Taipei Medical University WanFang Hospital
last name: Yu Chen Huang, MD
phone: 886970746772
email: dhist2002@yahoo.com.tw
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University WanFang Hospital
investigator full name: Huang Yu Chen
investigator title: Attending physician of Dermatology Department
mesh term: Nails, Ingrown
sharing ipd: No