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

Not Applicable

Completed

Conditions: Diabetic Peripheral Neuropathy

Interventions: Device: Erchonia® FX-635™
Device: Placebo Laser

Registration Number: NCT02461225

Lead Sponsor: Erchonia Corporation

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erchonia® FX-635™	Erchonia® FX-635™	The Erchonia® FX-635™ is made up of 3 independent 17 milliWatts (mW), 635 nanometers (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other.
Placebo Laser	Placebo Laser	The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)	Baseline and 6 weeks	The Visual Analog Scale (VAS) from baseline to endpoint (6 weeks) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome. For the primary study outcome, the overall study success is defined as a 35% or greater difference between the proportion (number) of individual successes in each treatment group.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Rating on the Visual Analog Scale (VAS)	Baseline and 6 weeks	The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.