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Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Primary Purpose

Ingrown Nail

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Podofix nail brace
Combiped nail brace
Podofix and then Combiped nail brace
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ingrown Nail

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • more or equal to 12 years old patient with ingrown toenail

Exclusion Criteria:

  • < 12 years old
  • under other nail bracing use
  • received partial nail resection within recent 2 months
  • psoriatic nail
  • target therapy related paronychia
  • received combiped or podofix previously and removed within recent 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Podofix nail brace

    Combiped nail brace

    Podofix and then Combiped nail brace

    Arm Description

    for mild ingrown toenails

    for Severe dystrophic ingrown toenails

    for Ingrown toenails with pyogenic granuloma

    Outcomes

    Primary Outcome Measures

    Improvement (change) by Physician global assessment (0-6)

    Secondary Outcome Measures

    Pain score (VAS0-10)
    Improvement (change) by Patient global assessment (VAS 0-10)
    Treatment satisfaction (VAS 0-10)
    Quality of life by Questionnaire

    Full Information

    First Posted
    December 22, 2016
    Last Updated
    December 29, 2016
    Sponsor
    Taipei Medical University WanFang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03008629
    Brief Title
    Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails
    Official Title
    Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Medical University WanFang Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ingrown Nail

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Podofix nail brace
    Arm Type
    Experimental
    Arm Description
    for mild ingrown toenails
    Arm Title
    Combiped nail brace
    Arm Type
    Experimental
    Arm Description
    for Severe dystrophic ingrown toenails
    Arm Title
    Podofix and then Combiped nail brace
    Arm Type
    Experimental
    Arm Description
    for Ingrown toenails with pyogenic granuloma
    Intervention Type
    Device
    Intervention Name(s)
    Podofix nail brace
    Intervention Description
    Podofix nail brace
    Intervention Type
    Device
    Intervention Name(s)
    Combiped nail brace
    Intervention Description
    Combiped nail brace
    Intervention Type
    Device
    Intervention Name(s)
    Podofix and then Combiped nail brace
    Intervention Description
    Podofix and then Combiped nail brace
    Primary Outcome Measure Information:
    Title
    Improvement (change) by Physician global assessment (0-6)
    Time Frame
    1 month, 3 months and 6 months after the device applied
    Secondary Outcome Measure Information:
    Title
    Pain score (VAS0-10)
    Time Frame
    1 month, 3 months and 6 months after the device applied
    Title
    Improvement (change) by Patient global assessment (VAS 0-10)
    Time Frame
    1 month, 3 months and 6 months after the device applied
    Title
    Treatment satisfaction (VAS 0-10)
    Time Frame
    1 month, 3 months and 6 months after the device applied
    Title
    Quality of life by Questionnaire
    Time Frame
    1 month, 3 months and 6 months after the device applied

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: more or equal to 12 years old patient with ingrown toenail Exclusion Criteria: < 12 years old under other nail bracing use received partial nail resection within recent 2 months psoriatic nail target therapy related paronychia received combiped or podofix previously and removed within recent 6 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu Chen Huang, MD
    Phone
    886970746772
    Email
    dhist2002@yahoo.com.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu Chen Huang, MD
    Organizational Affiliation
    Taipei Medical University WanFang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

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