Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications (LASER-1)
Onychomycosis
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
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.
Sites / Locations
- Isala Diabetes Centre, Isala Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Nd:YAG laser pulse therapy
Sham
Nd:YAG laser pulse therapy Patients are treated with laser session in week 0, 2, 4, and 12. The settings are; 1064 nm, spot size 3 mm, 20 J /cm2, 5 Hz, power 10 W, pulse duration 132 millisecond. A maximum of two sequential sessions (one session on the horizontal and one the vertical passing) will be applied to eliminate potential safety issues in those patients with a lack protective sensibility.
Sham treatment Patients are treated with a sham session in week 0, 2, 4, and 12. The study settings are similar to the laser except the laser beam. Because the patient is also blinded, they can't see the procedure. The sound and the beeps are audible similar to the laser treatment.