Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

Completed

• Conditions: Prevalence of Onychomycosis; Diabetic Neuropathic Patients; Diagnostic of Onychomycosis; Patients Clinically Suspected of Onychomycosis; Reliability of the Diagnosis of Onychomycosis

• Registration Number: NCT00525187
• Lead Sponsor: Vésale Hospital

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.

Study Timeline

• Study Start: 2000-12
• Study Completion: 2005-01
• Status Verified: 2007-08
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-09-04
• Last Update Submitted: 2007-09-04
• Study First Posted: 2007-09-05
• Last Update Posted: 2007-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

CHU A Vésale; 🇧🇪 Montigny-le-Tilleul, Hainaut, Belgium