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
About this trial
This is an interventional treatment trial for Ingrown Nail
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
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
NCT ID
NCT03008629
First Posted
December 22, 2016
Last Updated
December 29, 2016
Sponsor
Taipei Medical University WanFang Hospital
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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