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NCT00525187 Clinical Trial

Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

Diabetic Neuropathic Patients Clinical Trial

Official title:
Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00525187
Other study ID # Onychomycosis
Secondary ID
Status Completed
Phase N/A
First received August 20, 2007
Last updated September 4, 2007
Start date December 2000
Est. completion date January 2005

Study information
Verified date August 2007
Source Vésale Hospital
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium CHU A Vésale Montigny-le-Tilleul Hainaut

Sponsors (2)
Lead Sponsor Collaborator
Vésale Hospital Janssen-Cilag Ltd.

Country where clinical trial is conducted

Belgium,