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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT02927951
Eligibility Criteria:
Inclusion Criteria:
* Individuals with painful, peripheral neuropathy (ages 40-75 years) and type 2 diabetes (n=40).
Exclusion Criteria:
* Active ocular or systemic disease
* Recent or recurrent history of musculoskeletal injury,
* Presence of neurological conditions or idiopathic neuropathy
* History of or vertigo
* Use of an aid while walking or difficulty with standing upright
* Visible tremor or uncorrected visual deficits.
* Presence of type 1 diabetes mellitus (defined as C-peptide \< 1 ng/ml or diabetes onset at \< 35 years of age in a non-obese patient).
* Presence of diabetic retinopathy that is more severe than "background" level.
* Presence of diabetic nephropathy
* Presence of clinically significant neuropathy that is clearly of non-diabetic origin, e.g. alcoholic or autoimmune.
* Bilateral amputation of lower extremities or foot ulcers involving the great toes.
* Presence of neuroarthropathy (Charcot deformity) is allowable.
* History of major macrovascular events such as myocardial infarction or stroke within the past 6 months.
* Patients with moderate or severe hepatic insufficiency or abnormalities of liver function.
* Presence of significant pedal edema.
* Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT02927951
Study Brief:
Protocol Section:
NCT02927951