Skip to content

Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03008629
Enrollment
40
Registered
2017-01-02
Start date
2017-01-31
Completion date
2017-12-31
Last updated
2017-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ingrown Nail

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.

Interventions

DEVICEPodofix nail brace

Podofix nail brace

DEVICECombiped nail brace

Combiped nail brace

DEVICEPodofix and then Combiped nail brace

Podofix and then Combiped nail brace

Sponsors

Taipei Medical University WanFang Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Improvement (change) by Physician global assessment (0-6)1 month, 3 months and 6 months after the device applied

Secondary

MeasureTime 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 Questionnaire1 month, 3 months and 6 months after the device applied

Contacts

Primary ContactYu Chen Huang, MD
dhist2002@yahoo.com.tw886970746772

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026