Acquired Hallux ValgusNCT02464839
Prevalence and Clinical Characteristics of the Fungal Nail and Feet Infection in Patients With Hallux Valgus
An observational study of Acquired Hallux Valgus, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Hallux Valgus
- How many people
- 81 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acquired Hallux Valgus
- Keywords
- Fungal nails and feet infection, Onychomycosis, Hallux valgus
- Medical subject headings
- Hallux Valgus, Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charussri - Leeyaphan, MD., Principal investigator, Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464839
- Sponsor's protocol ID
- Fungalhallux
- Status last verified
- Sep 2015
- First submitted
- 30 Apr 2015
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Characteristics of the Fungal Nail and Feet Infection in Patients With Hallux Valgus
- ClinicalTrials.gov ID
- NCT02464839
- Acronym / sponsor ID
- Fungalhallux
- Conditions
- Acquired Hallux Valgus
- Keywords
- Fungal nails and feet infection, Onychomycosis, Hallux valgus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
The severity of onychomycosis in hallux valgus patients by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline
Time frame: 4 months
The number of coexisting of tinea pedis cases with onychomycosis in hallux valgus patients
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charussri - Leeyaphan, MD. principal investigator
Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Hallux Valgus, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of onychomycosis cases in hallux valgus patients (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2015.