Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Taipei Medical University

Status: Unknown

Conditions: Ingrown Nail

Treatments: Device: Combiped nail brace; Device: Podofix and then Combiped nail brace; Device: Podofix nail brace

Study type: Interventional

Funder types: Other

Identifiers

NCT03008629

N201610005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 3 patient groups

Podofix nail brace

Experimental group

Description:

for mild ingrown toenails

Treatment:

Device: Podofix nail brace

Combiped nail brace

Experimental group

Description:

for Severe dystrophic ingrown toenails

Treatment:

Device: Combiped nail brace

Podofix and then Combiped nail brace

Experimental group

Description:

for Ingrown toenails with pyogenic granuloma

Treatment:

Device: Podofix and then Combiped nail brace