Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients - Full Text View

Sponsors and Collaborators:	Vésale Hospital Janssen-Cilag Ltd.
Information provided by:	Vésale Hospital
ClinicalTrials.gov Identifier:	NCT00525187

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Defined Population, Prospective Study
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, Hainaut
CHU A Vésale
Montigny-le-Tilleul, Hainaut, Belgium, 1190

Sponsors and Collaborators

Vésale Hospital

Janssen-Cilag Ltd.

Investigators

Principal Investigator:

Isabelle J DUMONT, MD

unaffiliated

More Information

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

Keywords provided by Vésale Hospital:

onychomycosis
diabetic neuropathic patients
reliability of the diagnostic of onychomycosis

Study placed in the following topic categories:

Mycoses
Skin Diseases, Infectious
Onychomycosis

Skin Diseases
Tinea
Dermatomycoses

Additional relevant MeSH terms:

Nail Diseases
Infection

ClinicalTrials.gov processed this record on January 14, 2009