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:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT03596203
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years of age.
2. Prescription pharmacologic treatment is insufficient for treatment of pain.
3. Pain duration of more than one months.
4. Pain occurs daily.
5. Chronic DN associated pain that is located in bilateral feet and is not explained by a central anatomic nerve compression and can clearly be correlated with that patient's history of diabetes.
6. Pain intensity ≥ 5 in each foot at the time of enrollment.
Exclusion Criteria:
1. Life expectancy ≤ 6 months.
2. Oral pain medication doses or active ingredient has changed significantly in the prior 2 weeks.
3. Inability to walk at least 10 steps (with or without a cane) before and after having to sit in a chair.
4. Another pain condition that might confound results (e.g., neuropathy from cancer chemotherapy).
5. Inability to undergo study assessments or complete questionnaires independently.
6. Active psychological co-morbidities (i.e., uncontrolled schizophrenia)
7. Currently using an opioid medication for the treatment of foot pain.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT03596203
Study Brief:
Protocol Section:
NCT03596203