fungal nail infection onychomycosis
Conditions
Interventions
One group receives treatment with a local laser treatment (Diode-pumped
solid-state laser) from a podiatrist and the other group receives treatment
according to a control procedure. The laser proced
1064 nm, spot
size 3 mm, 20 J /cm2, 5 Hz, power 10 W, pulse duration 132 millisecond.
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: known diabetes (type 1 or 2) over 18 years old clinically suspicion with microbiologic confirmation of onychomycosis at risk for diabetic foot ulcers defined by a Simm*s score 1 or 2 the nail has to be involved for at least 25% .
Exclusion criteria
Exclusion criteria: patients without microbiologic confirmation of fungal nail infection patients with diabetic foot ulcers or foot ulcer in the medical history patients who used systemic or topical antifungal agents during the preceding 3 months patients with insufficient knowledge of the Dutch language to understand the requirements of the study patients who use immunosuppressive medication will also be excluded. patients suffering from psoriasis with nail involvement, lichen planus, or other abnormalities that could result in clinically abnormal toenails will be excluded. patients with an ankle brachial index
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Complete cure of the target nail | — |
Secondary
| Measure | Time frame |
|---|---|
| • Microbiological cure of the target nail • Complete clinical cure of the target nail • Markedly improved target nail • Complete clinical cure of all clinically infected toes • Nail severity index below 6 (in patients with a score >6 at study entry) of the target toe • Health related quality of life • Surface with healthy target nail / all clinically infected toes • Patients free of hyperkeratosis | — |
Countries
Netherlands
Outcome results
None listed