Study of Low Level Laser Therapy to Treat Diabetic Peripheral Neuropathy Foot Pain

Inclusion Criteria

• Existing clinical diagnosis of diabetes induced Peripheral Neuropathy documented by a suitably qualified and licensed medical professional
• Significant spontaneous foot pain that occurs approximately equally (comparably) bilaterally
• Significant spontaneous pain of 50 or greater on the 0-100 Visual Analog Scale (VAS) for the feet overall
• Foot pain is chronic, defined as having been ongoing for at least 3 months, bilaterally
• Stable anti-diabetic medication regimen for the prior 30 days or on no anti-diabetic medication regimen for the prior 30 days
• Willing and able to refrain from consuming any non-study over-the-counter and/or prescription medications or therapies for the relief of pain/inflammation throughout study participation
• Primary language is English.

Exclusion Criteria

• No definitive clinical diagnosis of diabetes induced Peripheral Neuropathy or foot pain is undiagnosed, or diagnosed as being other than, or in addition to, diabetes induced Peripheral Neuropathy
• Foot pain is unilateral or notably different between the two feet
• Self-reported Degree of Pain rating on the Visual Analog Scale (VAS) pain scale is less than 50 for both feet overall
• Serious organ disease or other serious primary disease merger
• Diabetes ketosis, ketoacidosis or severe infection within the past 2 weeks
• Current, active chronic pain disease
• Cancer or treatment for cancer in the past 6 months
• Use of any analgesics, or an equivalent of over-the counter or prescription NSAIDs (nonsteroidal anti-inflammatory drugs) within 7 days prior to study initiation
• Use of any antidepressants within 30 days prior to study initiation
• Use of any of the following prescription medications within 30 days prior to study initiation: Neurontin; Lyrica; Tramadol; Opioid medicines such as Ultram and Ultracet
• Injections of local anesthetics such as lidocaine within the past 30 days
• Surgical intervention to treat diabetic peripheral neuropathy foot pain, including implantation of a pain relief device
• Active infection, wound or other external trauma to the treatment areas
• Medical, physical, or other contraindications for, or sensitivity to, light therapy
• Pregnant, breast feeding, or planning pregnancy prior to the end of study participation
• Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years
• Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the consent form and/or ability to record study measurements
• Involvement in litigation/receiving disability benefits related to the parameters of the study
• Participation in other research in the past 30 days