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Completed

NCT Number: NCT00525187

Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Vésale Hospital

Other

Collaborators

  • Janssen-Cilag Ltd.

Registry information

Important dates

Study start
2000
Study completion
2005
First posted
Sep 5, 2007
Registry last updated
Sep 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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