Prevalence of OnychomycosisNCT00525187
Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients
An observational study of Prevalence of Onychomycosis and Diabetic Neuropathic Patients, run by Vésale Hospital at 1 site in Belgium.
Trial summary
The prevalence of onychomycosis among diabetic patients is still a debated question as well as the best way to diagnose the disease. We conducted a prospective study to assess the prevalence of onychomycosis in diabetic neuropathic (DN) patients clinically suspected of this disease and to assess the reliability of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prevalence of Onychomycosis, Diabetic Neuropathic Patients, Diagnostic of Onychomycosis
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2000to Jan 2005
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria were: presence of diabetes mellitus, type 1 or type 2, age between 18 and 80 years, neuropathy demonstrated by a VPT (Vibration Perception Threshold) >25 volts tested with a neurothesiometer (Horwell Scientific, London, UK) and a clinical diagnosis of onychomycosis.
Who cannot join
- Exclusion criteria were a history of psoriasis, systemic antifungal therapy during the year preceding the enrolment, immunosuppression either by disease or treatment induced.
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of onychomycosis among diabetic patients is still a debated question as well as the best way to diagnose the disease. We conducted a prospective study to assess the prevalence of onychomycosis in diabetic neuropathic (DN) patients clinically suspected of this disease and to assess the reliability of the diagnosis of onychomycosis.
Read the detailed description
From December 2000 to January 2005, we followed 100 successive diabetic patients, type 1 and type 2, suffering from (DN). At baseline we assessed age, gender, medical history and medications, foot insensitivity defined by a vibration perception threshold (VPT) >25 volts and onychomycosis by clinical diagnosis.
Multiple samples of the most affected nail, often the big toe, were taken. A potassium hydroxide (KOH) test was done by 2 independent and blinded investigators and a culture in a laboratory (lab) specialized in mycology.
Pictures of the nails and particularly of the sampled nail were taken. Apart from the laboratory results, two independent and blinded dermatologists gave their diagnosis looking at the pictures.
- Conditions
- Prevalence of Onychomycosis, Diabetic Neuropathic Patients, Diagnostic of Onychomycosis, Patients Clinically Suspected of Onychomycosis, Reliability of the Diagnosis of Onychomycosis
- Keywords
- onychomycosis, diabetic neuropathic patients, reliability of the diagnostic of onychomycosis
- Medical subject headings
- Onychomycosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startDec 2000
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevalence of OnychomycosisStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vésale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Investigators
- Isabelle J DUMONT, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525187
- Sponsor's protocol ID
- Onychomycosis
- Status last verified
- Aug 2007
- First submitted
- 20 Aug 2007
- Last updated
- 5 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients
- ClinicalTrials.gov ID
- NCT00525187
- Acronym / sponsor ID
- Onychomycosis
- Conditions
- Prevalence of Onychomycosis, Diabetic Neuropathic Patients, Diagnostic of Onychomycosis, Patients Clinically Suspected of Onychomycosis, Reliability of the Diagnosis of Onychomycosis
- Keywords
- onychomycosis, diabetic neuropathic patients, reliability of the diagnostic of onychomycosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vésale HospitalUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- Dec 2000
- Study completion
- Jan 2005 (actual)
- First posted
- 5 Sep 2007 (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.
The prevalence of onychomycosis among diabetic patients is still a debated question as well as the best way to diagnose the disease. We conducted a prospective study to assess the prevalence of onychomycosis in diabetic neuropathic (DN) patients clinically suspected of this disease and to assess the reliability of the diagnosis of onychomycosis.
Detailed description
From December 2000 to January 2005, we followed 100 successive diabetic patients, type 1 and type 2, suffering from (DN). At baseline we assessed age, gender, medical history and medications, foot insensitivity defined by a vibration perception threshold (VPT) >25 volts and onychomycosis by clinical diagnosis.
Multiple samples of the most affected nail, often the big toe, were taken. A potassium hydroxide (KOH) test was done by 2 independent and blinded investigators and a culture in a laboratory (lab) specialized in mycology.
Pictures of the nails and particularly of the sampled nail were taken. Apart from the laboratory results, two independent and blinded dermatologists gave their diagnosis looking at the pictures.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were: presence of diabetes mellitus, type 1 or type 2, age between 18 and 80 years, neuropathy demonstrated by a VPT (Vibration Perception Threshold) >25 volts tested with a neurothesiometer (Horwell Scientific, London, UK) and a clinical diagnosis of onychomycosis.
Key exclusion criteria (1 listed)
- Exclusion criteria were a history of psoriasis, systemic antifungal therapy during the year preceding the enrolment, immunosuppression either by disease or treatment induced.
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
Not reported in the source record.
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 5 Sep 2007.
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.
Isabelle J DUMONT, MD principal investigator
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 Prevalence of Onychomycosis and Diabetic Neuropathic Patients, run by Vésale Hospital at 1 site in Belgium.
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 1 inclusion and 1 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 5 Sep 2007. 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 Belgium. 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.
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 5 Sep 2007.