Lead Sponsor

University of Miami

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

•1. Subjects between the ages of 18 - 65.
•2. Subjects with confirmed Diabetes Mellitus as defined by the American Diabetes Association (ADA), a glycosylated hemoglobin (HbA1c) of 6.5%, a fasting blood glucose \> 126 mg/dL, or an oral glucose tolerance test \> 200 mg/dL.
•3. Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
•4. Subjects who have neuropathic pain as defined by a minimum score of 4 or higher on the Douleur Neuropathique en 4 Questions (DN4). In addition, the location of pain must be present within the same region of neuropathy symptoms.
•5. Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.

•1. Subjects who have pain due to some other form of neuropathy (chemo-induced neuropathy, alcohol induced neuropathy, exposure to toxins/chemicals, vitamin b12 deficiency, etc.) assessed via a medical history.
•2. Subjects with current or history of central nervous system disorders.
•3. Subjects with resting hypertension (HTN) \>/= 160/90 mmHg or known uncontrolled hypertension, coronary artery disease, heart failure, retinopathy, chronic obstructive pulmonary disease, end-stage renal disease, or current open foot ulcers.
•4. Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
•5. Subjects with Reynaud's disease or cold urticaria.
•6. All vulnerable populations including adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners, individuals with cognitive impairment.

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