Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00525187

Enrollment

100

Registered

2007-09-05

Start date

2000-12-31

Completion date

2005-01-31

Last updated

2007-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

onychomycosis, diabetic neuropathic patients, reliability of the diagnostic of onychomycosis

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.

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.

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Countries

Belgium

Outcome results