Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT01996995
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01996995
Study Brief:
Protocol Section:
NCT01996995