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Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

This study has been completed.
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by:
Vésale Hospital
ClinicalTrials.gov Identifier:
NCT00525187
First received: August 20, 2007
Last updated: September 4, 2007
Last verified: August 2007

August 20, 2007
September 4, 2007
December 2000
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Complete list of historical versions of study NCT00525187 on ClinicalTrials.gov Archive Site
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Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients
Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Cross-Sectional
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  • Prevalence of Onychomycosis
  • Diabetic Neuropathic Patients
  • Diagnostic of Onychomycosis
  • Patients Clinically Suspected of Onychomycosis
  • Reliability of the Diagnosis of Onychomycosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2005
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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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00525187
Onychomycosis
No
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Vésale Hospital
Janssen-Cilag Ltd.
Principal Investigator: Isabelle J DUMONT, MD
Vésale Hospital
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP