Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications

Setting of the study: Hospital, outpatient departments (Foot clinic, Isala, Zwolle)

Inclusion criteria

Patients with clinical suspicion and microbiologic confirmation of onychomycosis , diagnosis of T1DM or T2DM, 18 years or older, at risk for diabetic foot ulcers defined by a modified Simm's classification score 1 or 2 with either neuropathy or PAD, nail involvement of at least 25% of the target nail.

Exclusion criteria

no microbiologic confirmation, Simms' classification score 3, the presence or history of diabetic foot ulcers, ischemic pain, ankle brachial index < 0.9, patients receiving dialysis, severe renal insufficiently (eGFR below 30 ml/min), a documented toe pressure below 50 mmHg, use of systemic or topical antifungal agents 3 months prior to inclusion, use of immunosuppressive drugs, presence of psoriasis, lichen planus, or other abnormalities that could result in clinically abnormal toenails, a history of epilepsy and insufficient knowledge of the Dutch language. Patients with a dark skin color (Fitzpatrick 4 and 5) are excluded since dark skin color is associated with dark nails, which theoretically leads to increased temperatures during laser application

Inclusion criteria

• Diabetes
• Over 18 years old
• Clinically suspicion with microbiologic confirmation of onychomycosis
• Patient is at risk for diabetic foot ulcers defines as Simms score 1, 2 .

Exclusion criteria

• Patients without the microbiological confirmation of fungal nail infection
• Patients with an active or history of a diabetic foot ulcer
• Patients who used systemic or topical anti fungal agents during the preceding 3 months
• Patients with ischemic rest pain
• Patients with ankle brachial index < 0.9
• Patients with a documented toe pressure below 50 mmHg
• Patients receiving dialysis, severe renal insufficiently (eGFR below 30 ml/min)
• Patients with an insufficient knowledge of the Dutch language to understand requirements of the study
• Patients with a dark skin color (Fitspatrick 4 and 5)
• Patients who uses immunosuppressive medication
• Patient suffering from nail psoriasis , lichen planus, or other abnormalities that could result in clinically abnormal toenails.