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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT04504305
Eligibility Criteria:
Inclusion Criteria:
* Male and Females aged ≥ 40 and ≤ 65 years of age.
* Participants with primary complaints of lower limb pain.
* History of Diabetes mellitus for more than one year.
* Participants with HbA1c ≥ 7.1 and ≤ 9.5%
Exclusion Criteria:
* Diagnosed with severe cardiac disease
* Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥ 85.
* Type II DM with history of foot ulcers in the last six months prior to the study
* History of nerve damage not due to Painful Diabetic Neuropathy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT04504305
Study Brief:
Protocol Section:
NCT04504305