Please select the eligibility criteria that correspond to the clinical trial below.
Title: Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications
Brief Summary: In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn leads to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent skiving and clipping of the nails. No effective curative local therapies exist and systemic agents are often withheld due to concerns for side effects and interactions.

Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application on the one-year clinical and microbiological cure rate in a randomised, double-blinded sham-controlled design with blinded outcome assessment.

Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot ulcers.

Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The laser procedure will be performed as a sham procedure by a second podiatrist.

Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate (clinical and microbiological) after one year.


Options:
A: Inclusion Criteria:

* Presence of onychomycosis of the target toenail
* A positive fungal culture from the target toenail

Exclusion Criteria:

* Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations
* Presence of tinea pedis (athletes foot)
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
B: Inclusion Criteria:

* Clinically diagnosed onychomycosis of the target nail
* Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
* Has a positive KOH examination from the target nail
* Has a positive dermatophyte culture from the target nail

Exclusion Criteria:

* Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
* Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
* Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
C: 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.
D: Inclusion Criteria:

* Clinically diagnosed onychomycosis of the target nail
* Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
* Has a positive KOH examination from the target nail
* Has a positive dermatophyte culture from the target nail

Exclusion Criteria:

* Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
* Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
* Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Answer: C