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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Podofix nail brace | Experimental | for mild ingrown toenails |
|
| Combiped nail brace | Experimental | for Severe dystrophic ingrown toenails |
|
| Podofix and then Combiped nail brace | Experimental | for Ingrown toenails with pyogenic granuloma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Podofix nail brace | Device | Podofix nail brace |
| |
| Combiped nail brace |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement (change) by Physician global assessment (0-6) | 1 month, 3 months and 6 months after the device applied |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Chen Huang, MD | Contact | 886970746772 | dhist2002@yahoo.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yu Chen Huang, MD | Taipei Medical University WanFang Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D009263 | Nails, Ingrown |
| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Device |
Combiped nail brace |
|
| Podofix and then Combiped nail brace | Device | Podofix and then Combiped nail brace |
|
| 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 |