Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Ingrown Nail Clinical Trial

Official title:

Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03008629
• Other study ID #: N201610005
• Status: Not yet recruiting
• Phase: N/A
• First received: December 22, 2016
• Last updated: December 29, 2016
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Taipei Medical University WanFang Hospital
• Contact: Yu Chen Huang, MD
• Phone: 886970746772
• Email: dhist2002[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ingrown Nail
• Nails, Ingrown

Intervention

Device:
• Podofix nail brace
Podofix nail brace
• Combiped nail brace
Combiped nail brace
• Podofix and then Combiped nail brace
Podofix and then Combiped nail brace

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement (change) by Physician global assessment (0-6)		1 month, 3 months and 6 months after the device applied	No
Secondary	Pain score (VAS0-10)		1 month, 3 months and 6 months after the device applied	No
Secondary	Improvement (change) by Patient global assessment (VAS 0-10)		1 month, 3 months and 6 months after the device applied	No
Secondary	Treatment satisfaction (VAS 0-10)		1 month, 3 months and 6 months after the device applied	No
Secondary	Quality of life by Questionnaire		1 month, 3 months and 6 months after the device applied	No