Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Not Applicable

• Conditions: Ingrown Nail

• 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

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
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