| Registry | NCT03008629 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Taipei Medical University WanFang Hospital (Other) |
| Conditions | Ingrown Nail |
| Interventions | Podofix nail brace, Combiped nail brace, Podofix and then Combiped nail brace (Device) |
| Dates | start 2017-01-01, primary completion 2017-12-01 (estimated), completion 2017-12-01 (estimated), first posted 2017-01-02, last updated 2017-01-02 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Podofix nail brace | Experimental | Device: Podofix nail brace | for mild ingrown toenails |
| Combiped nail brace | Experimental | Device: Combiped nail brace | for Severe dystrophic ingrown toenails |
| Podofix and then Combiped nail brace | Experimental | Device: Podofix and then Combiped nail brace | for Ingrown toenails with pyogenic granuloma |
Sex: All, ages: 12 Years to any
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