Nociceptive Pain Fiber Response

Inclusion Criteria

• Subject age is greater than or equal to 22 years and less than 80 years of age.
• Subject has documented Type 2 diabetes.
• Subject has an HgbA1c > 7% and 1.40 or 10 mmHg, the subject will not be eligible for enrollment and will be referred to a cardiologist for further evaluation.
• Subject has venous insufficiency classified by the Venous Insufficiency Classification System (CEAP) of grades C3, C4, C5, or C6. See Appendix F for description of the venous insufficiency grading.
• Subject has undergone decompression surgery on the index foot to treat peripheral neuropathy within 2 years of the Screening Visit.
• Subject requires or anticipates the need for surgery of any type during the 60 day treatment period.
• Subject is a smoker or has been a smoker within one year of the Screening Visit.
• Subject has a total foot thickness (plantar surface to mid-dorsal surface) of > 6 centimeters.
• Subject anticipates travelling over the course of the 60 day treatment period.
• Subject has received any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Screening Visit or is enrolled in another clinical trial.
• Subject has undergone any local injection into the index foot within 30 days prior to the Screening Visit or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products.
• Subject has used systemic corticosteroids within 2 months of the Screening Visit.
• Subject has a history of any uncontrolled medical illness that in the investigator's judgment places the subject at unacceptable risk for receipt of PEMF therapy.
• Subject has a history of malignancy within the past five 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.
• Subject has a serious psychosocial co-morbidity.
• Subject has a history of drug or alcohol abuse, as confirmed by urine drug screen, within one year prior to the Screening Visit.
• Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
• Subject is currently pregnant or planning on becoming pregnant prior to Day 60.
• Subject has been previously treated with the PROVANT Therapy System.
• Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen and study visits.