Clinical trial NCT03008629: Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails
Official title: Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ingrown Nail
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement (change) by Physician global assessment (0-6)
timeFrame: 1 month, 3 months and 6 months after the device applied
Secondary outcomes:
measure: Pain score (VAS0-10)
timeFrame: 1 month, 3 months and 6 months after the device applied
measure: Improvement (change) by Patient global assessment (VAS 0-10)
timeFrame: 1 month, 3 months and 6 months after the device applied
measure: Treatment satisfaction (VAS 0-10)
timeFrame: 1 month, 3 months and 6 months after the device applied
measure: Quality of life by Questionnaire
timeFrame: 1 month, 3 months and 6 months after the device applied
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Yu Chen Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: