Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Conditions
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Ingrown Nail

Intervention / Treatment
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* Device: Podofix nail brace
* Device: Combiped nail brace
* Device: Podofix and then Combiped nail brace


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Podofix nail brace<br>for mild ingrown toenails | Device: Podofix nail brace<br>* Podofix nail brace<br>|
| Experimental: Combiped nail brace<br>for Severe dystrophic ingrown toenails | Device: Combiped nail brace<br>* Combiped nail brace<br>|
| Experimental: Podofix and then Combiped nail brace<br>for Ingrown toenails with pyogenic granuloma | Device: Podofix and then Combiped nail brace<br>* Podofix and then Combiped nail brace<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement (change) by Physician global assessment (0-6) |  | 1 month, 3 months and 6 months after the device applied | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (VAS0-10) |  | 1 month, 3 months and 6 months after the device applied | 
| Improvement (change) by Patient global assessment (VAS 0-10) |  | 1 month, 3 months and 6 months after the device applied | 
| Treatment satisfaction (VAS 0-10) |  | 1 month, 3 months and 6 months after the device applied | 
| Quality of life by Questionnaire |  | 1 month, 3 months and 6 months after the device applied |