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Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

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ClinicalTrials.gov Identifier: NCT00525187
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : September 5, 2007
Information provided by:

Study Description
Brief 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 diagnosis of onychomycosis.

Condition or disease
Prevalence of Onychomycosis Diabetic Neuropathic Patients Diagnostic of Onychomycosis Patients Clinically Suspected of Onychomycosis 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

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients
Study Start Date : December 2000
Study Completion Date : January 2005
Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclusion criteria were a history of psoriasis, systemic antifungal therapy during the year preceding the enrolment, immunosuppression either by disease or treatment induced.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525187

CHU A Vésale
Montigny-le-Tilleul, Hainaut, Belgium, 1190
Sponsors and Collaborators
Vésale Hospital
Janssen-Cilag Ltd.
Principal Investigator: Isabelle J DUMONT, MD
More Information

ClinicalTrials.gov Identifier: NCT00525187     History of Changes
Other Study ID Numbers: Onychomycosis
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: September 5, 2007
Last Verified: August 2007

Keywords provided by Vésale Hospital:
diabetic neuropathic patients
reliability of the diagnostic of onychomycosis

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases