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CompletedNCT00525187Updated Sep 5, 2007

Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

An observational study in Prevalence of Onychomycosis, Diabetic Neuropathic Patients and Diagnostic of Onychomycosis, sponsored by Vésale Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-09-05.

Sponsored by Vésale Hospital · Observational

Study type
Observational
Model
Defined population
Time perspective
Other
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • 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
03

In context

Onychomycosis

147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.

Browse Onychomycosis studies →

Lead sponsor

This is the only study on the registry with Vésale Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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:

  • Exclusion criteria were a history of psoriasis, systemic antifungal therapy during the year preceding the enrolment, immunosuppression either by disease or treatment induced.
05

Study design

Observational model
Defined population
Time perspective
Other
Enrollment
100 participants (actual)
06

Study locations

1 site
  • CHU A Vésale
    Montigny-le-Tilleul, Hainaut 1190, Belgium
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00525187
Lead sponsor
Vésale Hospital
Collaborators
Janssen-Cilag Ltd.
First posted
Sep 5, 2007
Start date
Dec 2000
Completion
Jan 2005
Last update
Sep 5, 2007

Study contacts

Isabelle J DUMONT, MD
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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