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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04000867
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years of age.
2. Pain duration of more than one month.
3. Pain occurs daily.
4. Chronic DN associated bilateral foot pain and is not explained by a central anatomic nerve compression and can clearly be correlated with that patient's history of diabetes.
5. Average Pain intensity ≥ 5 in each foot for at least 3 days 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/walker) before and after having to sit in a chair.
4. Another pain condition that might confound results (e.g., neuropathy from cancer chemotherapy, plantar fasciitis or arthritis of ankle and foot)
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\*\*.
8. Pregnancy
9. Inability to have MRI
10. Metal hardware and/or fragments in feet and ankles
11. Implanted pacemaker or a defibrillator, unless the device is considered MRI safe
* A significant change for this study is defined as a 20% increase or decrease in dosing of the patient's medication dose and/or or a change in the medication class (adding or removing other types of medicines used to treat pain).
* This exclusion is restricted to opioids, benzodiazepines and psychotropic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04000867
Study Brief:
Protocol Section:
NCT04000867