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

A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia® FX-635™ on Diabetic Peripheral Neuropathy Foot Pain Clinical Study Protocol

The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy.

It is the goal of the current double-blind, placebo-controlled study to evaluate the efficacy of the Erchonia FX-635 which emits (3) 635nm red diodes, for providing temporary reduction of foot pain associated with diabetic peripheral neuropathy.

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