Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management

Exclusion Criteria

• •1. Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia; subjects whose post- traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral.
• •2. Subjects with any other chronic or recurrent pain syndrome rated greater than "mild" on a mild-moderate-severe scale, or which the investigator judges may interfere with the patients ability to report their pain accurately.
• •3. Any disorder that may be confused with PDN, such as tarsal tunnel syndrome, sciatica, bunions, ischemic claudication or arthritis of the feet or ankles.
• •4. Subject has a currently diagnosed progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, or severe/critical spinal stenosis (stenosis).
• •5. Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.
• •6. Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain; subjects with significant somatic pain at the site of their trauma that may confound assessment or self-evaluation of their neuropathic pain.
• •7. Participation in any other clinical trial within the 30 days prior to screening and/or during participation in this study.
• •8. Any subject considered at risk of suicide or self-harm based on investigator judgment.
• •9. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality, or other factors that may increase the risk associated with study participation or investigational product administration or may interfere with compliance or the interpretation of study results and, in the judgment of the investigator would make the subject inappropriate to participate in the study.
• •10. Subjects with pending Worker's Compensation, Worker's Compensation, civil litigation, or disability claims. Subjects with fully resolved litigation and compensation claims can participate.
• •11. Subjects who have had a diagnosis of malignancy other than basal cell carcinoma, or carcinoma in situ of the cervix within the past five years, to include life expectancy less than 1 year due to advanced malignancy.
• •12. Subjects with implantable "electrical" medical devices such as a cardiac pacemaker, defibrillator, or insulin pump within four (4) inches or less of the site of pain to be treated by Axon Therapy. (Subject with an implantable device greater than four (4) inches from the site of pain to be treated should NOT be excluded).
• •13. Phantom limb pain or pain that feels like it is coming from a body part that is no longer there.
• •14. Subjects who have failed other neuromodulation implantable device for the same indication
• •15. Subjects with shrapnel or ferromagnetic objects
• •16. Subject is currently taking a morphine equivalent daily dose \> 120 mg/day.
• •17. Subject is a woman of childbearing potential, not using adequate contraception or not willing to comply with contraception for the duration of the study.
• •18. Subjects with active drug or alcohol abuse within 1 year prior to screening.
• •19. Subjects with hemoglobin A1C of 9% or higher for 90 days prior to screening.