Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Not Applicable

• Conditions: Ingrown Nail
• Interventions: Device: Podofix nail brace; Device: Combiped nail brace; Device: Podofix and then Combiped nail brace

• Registration Number: NCT03008629
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-29
• Last Update Submitted: 2016-12-29
• Study Start: 2017-01
• Study First Posted: 2017-01-02
• Last Update Posted: 2017-01-02
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Podofix nail brace	Podofix nail brace	for mild ingrown toenails
Combiped nail brace	Combiped nail brace	for Severe dystrophic ingrown toenails
Podofix and then Combiped nail brace	Podofix and then Combiped nail brace	for Ingrown toenails with pyogenic granuloma

Primary Outcome Measures

Name	Time	Method
Improvement (change) by Physician global assessment (0-6)	1 month, 3 months and 6 months after the device applied

Secondary Outcome Measures

Name	Time	Method
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
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