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

Multi-center, sham-controlled, double-blind, enriched enrollment, randomized withdrawal
clinical trial conducted on subjects with bilateral symmetrical diabetic peripheral
neuropathy. Eligible subjects will include those between 22 and 80 years of age with Type 1
or Type 2 diabetes having persistent pain, numbness, tingling, or burning in both feet
despite treatment. Eligible subjects will receive two active treatment devices (one for each
foot, to allow simultaneous treatment) and treat at home, twice daily for 60 days after which
they will return to the clinic at Day 61 for a response assessment. Subjects that are
determined to be responders at Day 61 (subjects that achieve a 1-point decrease in the
average pain score over the last 24 hours using the Numeric Pain Rating Scale (NPRS)) will be
randomized 1:1 to either active treatment or inactive sham devices and will continue treating
through Day 120. Subjects that are determined to be non-responders at Day 61 will continue
treating with the active devices given at enrollment and will return to the clinic at Day 75
and Day 91 for a response assessment. If a subject is determined to be a responder at Day 75,
they will be randomized 1:1 to receive either active treatment or inactive sham and will
continue treating through Day 120. If a subject is determined to be a responder at Day 91,
they will be randomized 1:1 to receive either active treatment or sham and will continue to
treat through Day 120. If a subject continues to be a non-responder at Day 91 they will be
terminated from the study.

Inclusion Criteria:

1. Subject age is greater than or equal to 22 years and less than 80 years of age.

2. Subject has documented Type 1 or Type 2 diabetes mellitus (receiving insulin, diet
controlled, or taking parenteral hypoglycemic agents)

3. Subject is on a stable antidiabetic regimen (medication and/or diet) to control their
diabetes for at least 30 days prior to Screening.

4. Subject has an HbA1c <10% at Screening or within 2 months of Screening.

5. Subject has daily pain attributed to bilateral symmetrical Diabetic Peripheral
Neuropathy with numbness, tingling, and/or burning based on clinical judgement for at
least 6 months prior to screening.

6. Subject's pain or discomfort from DPN is identifiable.

7. Subject is in pain Phase 2, 3, or 4 as per the Phasing of Neuropathy Scale.

8. Subjects average pain over the last 24 hours is ≥3 based on the 11-point Numeric Pain
Rating Scale (NPRS) at the Screening Visit.

9. Subject has adequate lower extremity pulse in both feet and no intermittent
claudication.

10. Subject is able to ambulate independently without assistive devices.

11. Subject is willing and able to give written informed consent and to comply with all
parts of the study protocol.

12. Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing
(or agrees to practice) an effective method of birth control if they are sexually
active for the duration of the study (Effective methods of birth control include
prescription hormonal contraceptives, intrauterine devices, double-barrier methods,
and/or male partner sterilization).

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.