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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Device: Erchonia® FX-635™; Device: Placebo Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co. Cork
    • Midleton, Co. Cork, Ireland
      • Midleton Foot Clinic
• United States
  • Arizona
    • Mesa, Arizona, United States, 85204
      • Arizona Institute of Footcare Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Erchonia® FX-635™; The Erchonia® FX-635™ is made up of 3 independent 17 mW, 635 nm red laser diodes that are applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced.
Placebo Comparator: Placebo Laser; The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light.	Device: Placebo Laser; The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. It is applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)	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.	Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Rating on the Visual Analog Scale (VAS)	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.	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Erchonia Corporation
• Investigators: Principal Investigator: Kerry Zang, DPN

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: EC_DPN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No