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 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT05165368
Eligibility Criteria:
Inclusion Criteria
Participants in this study must be/have:
* Older adults between 50 to 75 years of age
* Willing to actively improve neuropathy symptoms
* Diagnosed with Type II diabetes
* Moderate to severe DPN (diabetic peripheral neuropathy) with symptoms below the knees of numbness, tingling, burning, sharp pain, and/or increased sensitivity
* Distal Symmetric Polyneuropathy (DSPN) form of DPN
* Independent in daily activities
* Do not use any assistive device for walking such as a cane, walker, or wheelchair
Exclusion Criteria
* Currently consuming a mainly plant-based or gluten-free diet
* Known allergy to chrome, nickel, or cobalt
Any of the following medical conditions:
* Current regimen of chemotherapy, radiation, or dialysis
* Lower extremity amputations and open wounds
* Documented active drug and/or alcohol misuse
* End stage renal failure
* End stage congestive heart failure
* Uncontrolled hypertension
* Chronic liver disease
* Advanced chronic obstructive pulmonary disease
* Active inflammations
* Other types of neuropathies not associated with diabetes including B12 deficiency
* Any other chronic medical conditions requiring active treatment
* Morbid obesity
* Pregnancy (self-reported)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT05165368
Study Brief:
Protocol Section:
NCT05165368