Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Altering Toenail Biomechanic in Managing Ingrown Toenail.

NCT03732313

Ingrown Toenail

COMPLETED NA

Percutaneous Tenotomy of the Toe Flexor Tendon is a Simple and Efficient Method in Treating Checkrein Deformity

NCT01725893

Claw Toe

UNKNOWN

Nonrandomized Assessment of Ingrown ToenaiLs Treated by Excision of Skinfold Rather Than Toenail

NCT02067897

Nails, Ingrown

UNKNOWN

Management of Nailbed Injuries

NCT04652635

Nail Bed Injury

NOT_YET_RECRUITING NA

Conservative Treatment of Ingrown Toenail

NCT05214586

Ingrown Nail Nails, Abnormal

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ingrown Nail

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Podofix nail brace

for mild ingrown toenails

Group Type EXPERIMENTAL

Podofix nail brace

Intervention Type DEVICE

Podofix nail brace

Combiped nail brace

for Severe dystrophic ingrown toenails

Group Type EXPERIMENTAL

Combiped nail brace

Intervention Type DEVICE

Combiped nail brace

Podofix and then Combiped nail brace

for Ingrown toenails with pyogenic granuloma

Group Type EXPERIMENTAL

Podofix and then Combiped nail brace

Intervention Type DEVICE

Podofix and then Combiped nail brace

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Podofix nail brace

Intervention Type DEVICE

Combiped nail brace

Intervention Type DEVICE

Podofix and then Combiped nail brace

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No