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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03815305
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with Diabetes Mellitus Type 2
* \<60 years old by the end of the study
* suffered from dry skin on lower leg skin area, (minimum score= 3, measured using SRRC)
* agree to not use any skin care product orally or topically on lower leg skin and any other drugs (unless its part of diabetes mellitus management)
* normal ankle brachial index value ranged from 0.91-1.3
Exclusion Criteria:
* the presence of diabetic ulcer on one of patient's foot
* the presence of infection or dermatitis on the experimented foot
* the presence of severe inflammation on the experimented skin (redness score \>2 or/and fissure score \>2 measured by SRRC or/and total SRRC score ranged from12-16)
* estimated glomerular filtration rate value (eGFR) \< 45
* impaired liver function (increased by 2x from upper limit reference for AST/ALT)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
60 Years
Study:
NCT03815305
Study Brief:
Protocol Section:
NCT03815305