Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

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.

Study Overview

• Status: Unknown
• Conditions: Ingrown Nail
• Intervention / Treatment: Device: Podofix nail brace; Device: Combiped nail brace; Device: Podofix and then Combiped nail brace

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Podofix nail brace; for mild ingrown toenails	Device: Podofix nail brace; Podofix nail brace
Experimental: Combiped nail brace; for Severe dystrophic ingrown toenails	Device: Combiped nail brace; Combiped nail brace
Experimental: Podofix and then Combiped nail brace; for Ingrown toenails with pyogenic granuloma	Device: Podofix and then Combiped nail brace; Podofix and then Combiped nail brace

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Yu Chen Huang, MD, Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Estimate): January 2, 2017
• Last Update Submitted That Met QC Criteria: December 29, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Nail Diseases; Nails, Ingrown
• Other Study ID Numbers: N201610005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No