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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT03909802
Eligibility Criteria:
Individual inclusion criteria:
1. Individual both men and women who were diagnosed stage 2 and more of DFU by certified wound care nurses.
2. Individual having DFU located on the one or two legs.
3. An individual who either regularly or not regularly visits the selected wound care clinics.
4. Individual not in the fasting period either in Ramadan or another occasion.
5. An individual who able to read and communicate in Indonesia language.
Individual exclusion criteria:
1. Individual who is hospitalized due to the complexities of diabetes.
2. Individual who at the end of life care.
3. Individual who is currently having any critical condition which potentially interferes data collection processes such as acute diabetic ketoacidosis and impaired consciousness.
4. An individual who has blindness due to diabetes or aging.
Family inclusion criteria:
1. The individual is the caregiver or family members of an individual having DFU.
2. An individual who able to read and communicate in Indonesia language.
Family exclusion criteria:
Individuals who attend the program less than 80 percent due to getting sick or other reasons.
Termination criteria:
This study will be suspended or terminated some or all research activities if events are identified representing serious or continuing noncompliance or unanticipated health issues involving risk to subjects or others related to DFU complications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03909802
Study Brief:
Protocol Section:
NCT03909802