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.

Study Overview

• Status: Completed
• Conditions: Acquired Hallux Valgus

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.

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hallux valgus patients; All of participants will perform a potassium hydroxide (KOH) examination and fungal culture to prove a fungal nail and feet fungal infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of onychomycosis cases in hallux valgus patients	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of onychomycosis in hallux valgus patients by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline	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.	4 months
The number of coexisting of tinea pedis cases with onychomycosis in hallux valgus patients	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.	4 months

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Charussri - Leeyaphan, MD., Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Onychomycosis; Fungal nails and feet infection; Hallux valgus
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Infections; Hallux Valgus; Bunion
• Other Study ID Numbers: Fungalhallux

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No