Nociceptive Pain Fiber Response

The study is multi-site, randomized, double-blind, sham-controlled study of the safety and
efficacy of multi-dose Provant therapy to evaluate neuronal and vascular response in the
treatment of subjects with painful peripheral diabetic neuropathy. Subjects will be
randomized in a 2:1 ratio to receive therapy with an active device or an identical inactive
sham device. Subjects will treat at home twice daily for 60 days after which they will return
to the clinic for final evaluations. Subjects will be evaluated at the research center for a
Baseline/Enrollment visit and again at Day 61 where assessments for safety, concomitant
medications, Sympathetic Skin Response (SSR), Nerve Conduction Velocity (NCV), Skin Perfusion
Pressures (SPP), and Skin Biopsy will be completed. Subjects will be contacted via telephone
at Day 14, Day 28 and Day 42 to assess adherence, safety, and concomitant medications.
Subjects will also complete a Response to Study Device form which will capture their daily
pain score.

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 2 diabetes.

3. Subject has an HgbA1c > 7% and < 10%.

4. Subject has peripheral diabetic neuropathy with pain, numbness, tingling, and/or
burning in at least one foot confirmed by a positive provocative sign and a positive
Tinel's sign. If both feet are involved, the one with the greatest severity will be
selected as the index foot.

5. Subject is in pain Phase 2, 3, or 4 (Appendix C).

6. Subject is willing and able to give written informed consent and to comply with all
parts of the study protocol including diary entries.

7. Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing
(or agree 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 has Type 1 diabetes.

2. Subject is in pain Phase 1 or 5 (Appendix C).

3. Subject has an active, open ulcer on either lower extremity of arterial, venous or
mixed disease origin.

4. Subject has peripheral arterial disease as determined by an Ankle-Brachial Index (ABI)
of >1.40 or < 0.80. See Appendix E for details on obtaining the ABI.

NOTE: If the difference in the brachial pulse pressure between the right and left arms
is > 10 mmHg, the subject will not be eligible for enrollment and will be referred to
a cardiologist for further evaluation.

5. 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.

6. Subject has undergone decompression surgery on the index foot to treat peripheral
neuropathy within 2 years of the Screening Visit.

7. Subject requires or anticipates the need for surgery of any type during the 60 day
treatment period.

8. Subject is a smoker or has been a smoker within one year of the Screening Visit.

9. Subject has a total foot thickness (plantar surface to mid-dorsal surface) of > 6
centimeters.

10. Subject anticipates travelling over the course of the 60 day treatment period.

11. 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.

12. 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.

13. Subject has used systemic corticosteroids within 2 months of the Screening Visit.

14. 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.

15. 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.

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 60.

20. Subject has been previously treated with the PROVANT Therapy System.

21. Subject is unwilling or unable to follow study instructions, or comply with the
treatment regimen and study visits.