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Completed

NCT Number: NCT02464839

Prevalence and Clinical Characteristics of the Fungal Nail and Feet Infection in Patients With Hallux Valgus

This study was designed to demonstrate the prevalence of onychomycosis in hallux valgus patients. Additionally, all the prevalence of tinea pedis, the pattern of clinical manifestations, risk factors and coexistence foot deformities with hallux valgus were observed and recorded.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology

Bangkoknoi, Bangkok, 10700, Thailand

About this study

Hallux valgus is an abnormal deviation of the big toe away from the midline of the body or toward the other toes of the foot that is associated especially with the wearing of ill-fitting shoes-compare bunion. According to the previous studies, the association of nails and feet of disorder such as superficial fugal foot infection, abnormal nail shape and onychomycosis was reported. Nevertheless, nail disorders have been neglected for examination and treatment due to asymptomatic clinical manifestations and low effects in quality of life, even though it is the common dermatologic problem in general population.

Nail disorders that coincidentally happen with foot deformities can cause by either onychomycosis or nail trauma. Unfortunately, clinical presentation of them is similar. Nevertheless onychomycosis is the common superficial fungal infection in Thai population. So that the empirical systemic treatment of onychomycosis in older patients by systemic therapy such as azoles group and terbinafine according to the standard regimen maybe induce serious side effects. If onychomycosis is suspected, the abnormal nail should be taken to confirm the diagnosis will be required. Therefore, this study was designed to demonstrate the prevalence of onychomycosis in hallux valgus patients. Additionally, all the prevalence of tinea pedis, the pattern of clinical manifestations, risk factors and coexistence foot deformities with hallux valgus were observed and recorded.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants was 18 years old or above.
  • Participants were diagnosed hallux valgus foot deformity by specialists of physical medicine and rehabilitation based on clinical presentation at Foot Clinic, Siriraj hospital
  • Participants accept the aim of this project and sign the consent form by themselves.

Exclusion criteria

  • Participants have other nail disorders before participate the research.
  • Participants have the history of fungal infection treatment with one-month by topical or systemic therapy.
  • Participants have coincidental bacterial infection.

Treatment and study plan

Primary outcomes

  1. The number of onychomycosis cases in hallux valgus patients

    Time frame: 4 months

    To record the number of onychomycosis cases in hallux valgus patients from date of first patients documented progression until the date of end of study. The data was analysed as percentage.

Secondary outcomes

  1. The severity of onychomycosis in hallux valgus patients by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline

    Time frame: 4 months

    Patients with hallux valgus condition in this study were evaluated the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline.

  2. The number of coexisting of tinea pedis cases with onychomycosis in hallux valgus patients

    Time frame: 4 months

    To record the number of coexisting of tinea pedis cases in hallux valgus patients from date of first patients documented progression until the date of end of study.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2015
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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