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:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT03213093
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Type 2 diabetic subject
* Absence of active diabetic foot ulcer
* Patients "Grade 0", "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by:
* absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 0"
* alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 1"
* alteration of perception of Monofilament 10g at the level of the plantar arch associated with foot deformity and / or an arteriopathy defined by the absence of perception of one of the two peripheral pulses for the "grade 2"
* History of diabetic foot ulcer for the "grade 3"
* Signature of consent to participate in the study
Exclusion Criteria:
* Chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day
* Pregnancy
* Congenital methemoglobinemia.
* Porphyria
* Skin injured on the tibia, whatever the lesion
* Recent major cardiovascular history (less than 3 months)
* Severe renal disease (serum creatinine\> 300 μmol.l-1)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03213093
Study Brief:
Protocol Section:
NCT03213093