Clinical Trial: Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

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 Summary:

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.


Sponsor: Taipei Medical University WanFang Hospital

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain score (VAS0-10) [ Time Frame: 1 month, 3 months and 6 months after the device applied ]
  • Improvement (change) by Patient global assessment (VAS 0-10) [ Time Frame: 1 month, 3 months and 6 months after the device applied ]
  • Treatment satisfaction (VAS 0-10) [ Time Frame: 1 month, 3 months and 6 months after the device applied ]
  • Quality of life by Questionnaire [ Time Frame: 1 month, 3 months and 6 months after the device applied ]


Original Secondary Outcome: Same as current

Information By: Taipei Medical University WanFang Hospital

Dates:
Date Received: December 22, 2016
Date Started: January 2017
Date Completion: December 2017
Last Updated: December 29, 2016
Last Verified: December 2016