Clinical trial NCT02464839: Prevalence and Clinical Characteristics of the Fungal Nail and Feet Infection in Patients With Hallux Valgus
Official title: Prevalence and Clinical Characteristics of the Fungal Nail and Feet Infection in Patients With Hallux Valgus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Hallux Valgus
Keywords: Fungal nails and feet infection
Onychomycosis
Hallux valgus
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were diagnosed hallux valgus foot deformity by specialists of physical medicine and rehabilitation based on clinical presentation at Foot Clinic, Siriraj hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of onychomycosis cases in hallux valgus patients
timeFrame: 4 months
Secondary outcomes:
measure: The severity of onychomycosis in hallux valgus patients by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline
timeFrame: 4 months
measure: The number of coexisting of tinea pedis cases with onychomycosis in hallux valgus patients
timeFrame: 4 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Department of Dermatology
state: Bangkok
Study officials:
affiliation: Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
name: Charussri - Leeyaphan, MD.
role: PRINCIPAL_INVESTIGATOR
References: