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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
History of Changes
  Purpose

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
Prevalence of Onychomycosis
Diabetic Neuropathic Patients
Diagnostic of Onychomycosis
Patients Clinically Suspected of Onychomycosis
Reliability of the Diagnosis of Onychomycosis

Study Type: Observational
Study Design: 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

Further study details as provided by Vésale Hospital:

Enrollment: 100
Study Start Date: December 2000
Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525187

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

No publications provided

ClinicalTrials.gov Identifier: NCT00525187     History of Changes
Other Study ID Numbers: Onychomycosis
Study First Received: August 20, 2007
Last Updated: September 4, 2007
Health Authority: Belgium: Institutional Review Board

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

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013