- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03008629
Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu Chen Huang, MD
- Phone Number: 886970746772
- Email: dhist2002@yahoo.com.tw
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Podofix nail brace
for mild ingrown toenails
|
Podofix nail brace
|
Experimental: Combiped nail brace
for Severe dystrophic ingrown toenails
|
Combiped nail brace
|
Experimental: Podofix and then Combiped nail brace
for Ingrown toenails with pyogenic granuloma
|
Podofix and then Combiped nail brace
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement (change) by Physician global assessment (0-6)
Time Frame: 1 month, 3 months and 6 months after the device applied
|
1 month, 3 months and 6 months after the device applied
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain score (VAS0-10)
Time Frame: 1 month, 3 months and 6 months after the device applied
|
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
|
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
|
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
|
1 month, 3 months and 6 months after the device applied
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yu Chen Huang, MD, Taipei Medical University WanFang Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201610005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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