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

Inclusion Criteria

• Subject age is greater than or equal to 22 years and less than 80 years of age.
• Subject has documented Type 1 or Type 2 diabetes mellitus (receiving insulin, diet controlled, or taking parenteral hypoglycemic agents)
• Subject is on a stable antidiabetic regimen (medication and/or diet) to control their diabetes for at least 30 days prior to Screening.
• Subject has an HbA1c 1.4 and/or history of angioplasty or peripheral bypass surgery within 6 months of the Screening Visit.
• Subject has venous insufficiency as classified by the Venous Insufficiency Classification System of grade C6.
• Subject has undergone nerve decompression surgery on the lower extremities.
• Subject has a history of previous kidney, pancreas, cardiac transplantation, or severe renal disease.
• 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).
• Subject has peripheral vascular disease requiring revascularization of lower limb or amputation or evidence of ulcer amputation.
• 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).
• 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.
• Subject requires or anticipates the need for surgery of any type or travel during the treatment period.
• 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.
• 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.
• Subject has used systemic corticosteroids within 3 months of the Screening Visit.
• 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.
• 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 121.
• Subject has previously treated with PROVANT® Therapy System within 60 days on the lower extremity.
• Subject is unwilling or unable to follow study instructions or comply with the treatment regimen, diary documentation, and study visits.
• Subject has pain from any other source that can confuse the assessment of the pain associated with DPN.
• Subject has a clinically significant foot deformity (Charcot's syndrome or club foot).
• Subject has received nerve blocks for neuropathic pain within 4 weeks of the Screening Visit.
• Subject has been diagnosed with mononeuropathy.
• Subject has a skin condition that could alter their sensation.
• Subject has had a previous surgery to the spine or lower extremity with residual symptoms of pain or difficulty with movement.
• Subject has moderate or severe arthropathy (RA, OA, Gout) that causes discomfort during casual walking or stair climbing.