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

Acquired Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464839
• Other study ID #: Fungalhallux
• Status: Completed
• Phase: N/A
• First received: April 30, 2015
• Last updated: September 8, 2015
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Hallux Valgus
• Hallux Valgus

Locations

Country	Name	City	State
Thailand	Department of Dermatology	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes