Ingrown NailNCT03008629
Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails
A study testing Podofix nail brace, Combiped nail brace and Podofix and then Combiped nail brace in people with Ingrown Nail, run by Taipei Medical University WanFang Hospital.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Ingrown Nail
- What is being tested?
- Podofix nail brace, Combiped nail brace and Podofix and then Combiped nail brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- more or equal to 12 years old patient with ingrown toenail
Who cannot join
- < 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Ingrown Nail
- Being tested
- Podofix nail brace, Combiped nail brace, Podofix and then Combiped nail brace
- Medical subject headings
- Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podofix nail braceDevice
Podofix nail brace
Combiped nail braceDevice
Combiped nail brace
Podofix and then Combiped nail braceDevice
Podofix and then Combiped nail brace
| Study group | Role | What they receive |
|---|---|---|
| Podofix nail brace | Experimental | for mild ingrown toenails Receives: Device: Podofix nail brace |
| Combiped nail brace | Experimental | for Severe dystrophic ingrown toenails Receives: Device: Combiped nail brace |
| Podofix and then Combiped nail brace | Experimental | for Ingrown toenails with pyogenic granuloma Receives: Device: Podofix and then Combiped nail brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement (change) by Physician global assessment (0-6)
Measured: 1 month, 3 months and 6 months after the device applied
Secondary outcomes (4)
Pain score (VAS0-10)
Measured: 1 month, 3 months and 6 months after the device applied
Improvement (change) by Patient global assessment (VAS 0-10)
Measured: 1 month, 3 months and 6 months after the device applied
Treatment satisfaction (VAS 0-10)
Measured: 1 month, 3 months and 6 months after the device applied
Quality of life by Questionnaire
Measured: 1 month, 3 months and 6 months after the device applied
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ingrown NailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Yu Chen, Taipei Medical University WanFang Hospital
- Investigators
- Yu Chen Huang, MD, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008629
- Sponsor's protocol ID
- N201610005
- Status last verified
- Dec 2016
- First submitted
- 22 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails
- ClinicalTrials.gov ID
- NCT03008629
- Acronym / sponsor ID
- N201610005
- Conditions
- Ingrown Nail
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Podofix nail brace | Experimental | Device: Podofix nail bracefor mild ingrown toenails |
| Combiped nail brace | Experimental | Device: Combiped nail bracefor Severe dystrophic ingrown toenails |
| Podofix and then Combiped nail brace | Experimental | Device: Podofix and then Combiped nail bracefor Ingrown toenails with pyogenic granuloma |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- more or equal to 12 years old patient with ingrown toenail
Key exclusion criteria (6 listed)
- < 12 years old
- under other nail bracing use
- received partial nail resection within recent 2 months
- psoriatic nail
- target therapy related paronychia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Podofix nail bracePodofix nail brace | Device | Podofix nail brace |
| Combiped nail braceCombiped nail brace | Device | Combiped nail brace |
| Podofix and then Combiped nail bracePodofix and then Combiped nail brace | Device | Podofix and then Combiped nail brace |
Primary outcome
Improvement (change) by Physician global assessment (0-6)
Time frame: 1 month, 3 months and 6 months after the device applied
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Chen Huang, MD principal investigator
Taipei Medical University WanFang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Podofix nail brace, Combiped nail brace and Podofix and then Combiped nail brace in people with Ingrown Nail, run by Taipei Medical University WanFang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Chen Huang, MD (886970746772, dhist2002@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement (change) by Physician global assessment (0-6) (time frame: 1 month, 3 months and 6 months after the device applied). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.