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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT06778005
Eligibility Criteria:
Inclusion Criteria (Group 1):
* Being between the ages of 18-65
* Being literate
* Signed a voluntary consent form agreeing to participate in the study
Inclusion Criteria (Group 2):
* Diagnosed with Type 2 Diabetes based on at least one of the following diagnostic criteria: fasting plasma glucose ≥ 126 mg/dl, 2-hour plasma glucose ≥ 200 mg/dl in an oral glucose tolerance test, HbA1c ≥ 6.5%, or diabetes symptoms (excessive thirst, eating, urination, and weight loss) + random plasma glucose ≥ 200 mg/dl. (14)
* Diagnosed with diabetic peripheral polyneuropathy through EMG evaluation in addition to Type 2 Diabetes.
* Being between the ages of 18-65
* Being literate
* Signed a voluntary consent form agreeing to participate in the study.
Exclusion Criteria:
* Individuals under 18 years old and over 65 years old
* Diagnosed with Type 1 diabetes
* Use of medications that can cause polyneuropathy
* Other causes of neuropathic pain (lumbar radiculopathy, spinal stenosis, -hereditary, inflammatory, entrapment neuropathies)
* Undergoing lower extremity surgery (spine/hip/knee/foot) in the last 6 months
* Having peripheral artery disease
* B12 vitamin deficiency
* Active foot ulcer
* History of lower extremity amputation
* Severe cardiopulmonary insufficiency (stage 3-4)
* History of myocardial infarction within the last 1 month
* History of unstable angina
* Active systemic inflammatory diseases and active malignancy
* Presence of vestibular disorders
* Presence of cognitive impairment
* Osteoarthritis in the lower extremity
* Pregnancy
* Body Mass Index (BMI) of 30 or higher
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06778005
Study Brief:
Protocol Section:
NCT06778005