Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy

Exclusion Criteria

• •1. Subject is in pain Phase 1 or 5 as per the Phasing of Neuropathy Scale.
• •2. Subject has an active, open ulcer on the lower extremities.
• •3. Subject has peripheral vascular disease defined as absence of more than one foot pulse per foot and/or ABI \<0.8 and \>1.4 and/or history of angioplasty or peripheral bypass surgery within 6 months of the Screening Visit.
• •4. Subject has venous insufficiency as classified by the Venous Insufficiency Classification System of grade C6.
• •5. Subject has undergone nerve decompression surgery on the lower extremities.
• •6. Subject has a history of previous kidney, pancreas, cardiac transplantation, or severe renal disease.
• •7. Subject has been diagnosed with non-diabetic chronic inflammatory neuropathic disease (e.g. end stage renal disease, hepatitis C, chemotherapy induced neuropathy, known connective tissue disease, systemic lupus).
• •8. Subject has peripheral vascular disease requiring revascularization of lower limb or amputation or evidence of ulcer amputation.
• •9. Subject has clinically significant cardiovascular disease within 6 months prior to screening (unstable or poorly controlled hypertension, transient ischemic attack, MI, unstable angina, arrhythmia, any heart surgery, stent placement, heart disease).
• •10. Subject has a history of any uncontrolled medical illness that in the Investigators judgment places the subject at unacceptable risk for receipt of PEMF therapy.
• •11. Subject requires or anticipates the need for surgery of any type or travel during the treatment period.
• •12. Subject has a total foot depth (most inferior aspect of the medial malleolus to the plantar aspect of the foot when residing on a treatment pad) of \>8 cm.
• •13. Subject has received any investigational drug or device within 30 days prior to the Screening Visit or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products.
• •14. Subject has used systemic corticosteroids within 3 months of the Screening Visit.
• •15. Subject has a history of malignancy within the past 5 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area and/or localized in situ carcinoma of the cervix.
• •16. Subject has a serious psychosocial co-morbidity.
• •17. Subject has a history of drug or alcohol abuse, as confirmed by urine drug screen, within one year prior to the Screening Visit.
• •18. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
• •19. Subject is currently pregnant or planning on becoming pregnant prior to Day 121.
• •20. Subject has previously treated with PROVANT® Therapy System within 60 days on the lower extremity.
• •21. Subject is unwilling or unable to follow study instructions or comply with the treatment regimen, diary documentation, and study visits.
• •22. Subject has pain from any other source that can confuse the assessment of the pain associated with DPN.
• •23. Subject has a clinically significant foot deformity (Charcot's syndrome or club foot).
• •24. Subject has received nerve blocks for neuropathic pain within 4 weeks of the Screening Visit.
• •25. Subject has been diagnosed with mononeuropathy.
• •26. Subject has a skin condition that could alter their sensation.
• •27. Subject has had a previous surgery to the spine or lower extremity with residual symptoms of pain or difficulty with movement.
• •28. Subject has moderate or severe arthropathy (RA, OA, Gout) that causes discomfort during casual walking or stair climbing.