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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT04025320
Eligibility Criteria:
Inclusion Criteria:
* Patients with Diabetes Type 2 and Diabetic Peripheral Neuropathy with no other known underlying disease
* Below ankle Diabetic Peripheral Neuropathy symptoms (numbness, tingling, burning, sharp pain, increased sensitivity, etc.)
* ≥10 on Quality of Life- Diabetic Neuropathy Scale (QOL- DN)
* Between age 50-75 years
Exclusion Criteria:
* Patients with a medical condition that suggested possible decline in function over the next 6 months such as; a current regimen of chemotherapy, radiation therapy, or dialysis
* Any lower extremity amputations or wounds
* Documented active alcohol and/or drug misuse
* Known health conditions: end stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, advanced chronic obstructive pulmonary disease and active inflammations
* DM patients with inflammatory neuropathies including chronic inflammatory demyelinating polyneuropathy (CIDP), proximal diabetes neuropathy, and autonomic neuropathies
* Patients with other types of neuropathies not associated with Diabetes Mellitus such as B12 deficiency, hypothyroidism, and uremia
* Other severe chronic medical condition requiring active treatment
* Morbidly Obese patients
* Pregnancy (self reported)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT04025320
Study Brief:
Protocol Section:
NCT04025320