NCT03008629

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

December 22, 2016

Last Update Submit

December 29, 2016

Conditions

Ingrown Nail

Outcome Measures

Primary Outcomes (1)

  • Improvement (change) by Physician global assessment (0-6)

    1 month, 3 months and 6 months after the device applied

Secondary Outcomes (4)

  • 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 Questionnaire

    1 month, 3 months and 6 months after the device applied

Study Arms (3)

Podofix nail brace

EXPERIMENTAL

for mild ingrown toenails

Device: Podofix nail brace

Combiped nail brace

EXPERIMENTAL

for Severe dystrophic ingrown toenails

Device: Combiped nail brace

Podofix and then Combiped nail brace

EXPERIMENTAL

for Ingrown toenails with pyogenic granuloma

Device: Podofix and then Combiped nail brace

Interventions

Podofix nail braceDEVICE

Podofix nail brace

Podofix nail brace
Combiped nail braceDEVICE

Combiped nail brace

Combiped nail brace
Podofix and then Combiped nail braceDEVICE

Podofix and then Combiped nail brace

Podofix and then Combiped nail brace

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • more or equal to 12 years old patient with ingrown toenail

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nails, Ingrown

Condition Hierarchy (Ancestors)

Nail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yu Chen Huang, MD

    Taipei Medical University WanFang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Chen Huang, MD

CONTACT

886970746772dhist2002@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician of Dermatology Department

Study Record Dates

First Submitted

December 22, 2016

First Posted

January 2, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share