Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain

Inclusion Criteria:

• Previously diagnosed with diabetes induced peripheral neuropathy by a suitablyqualified and licensed health professional within the past 6 months

• Over the age of 18 years of age

• Able to read and write English.

• Constant feet pain on-going over at least the past 3 months.

• If using analgesics (pain medication), you must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14days prior to enrollment; and willing and able to not have planned upward dosetitration of analgesics during the study period. You may elect to decrease analgesicuse during the study. Cannabis prescribed for medicinal purposes would qualify as ananalgesic in this context.

• Willing and able to refrain from engaging in any non-study procedure therapies forthe management of foot pain throughout the course of study participation, includingconventional therapies such as physical therapy, occupational therapy and hot orcold packs, as well as alternative therapies such as chiropractic care andacupuncture.

• Agrees to refrain from taking a dosage of analgesic (pain medication) for at least 6hours before a scheduled VAS foot pain rating is to be recorded.

• Subjects' degree of foot pain on the 0-100 VAS, with "0" being no pain and "100"being worst pain imaginable, is 50 or greater.

Exclusion Criteria:

• Pregnant or think you might be pregnant.

• Open wounds (sores, cuts, ulcers, etc) around the feet

• Cancerous growths around the feet

• Difficulty with hand dexterity sufficient to impact ability to administer treatmentswith the laser such as from severe arthritis in the hands, Multiple Sclerosis,Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.