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

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Erchonia® FX-635™
Placebo Laser
Sponsored by
Erchonia Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Institute of Footcare Physicians
  • Midleton Foot Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Erchonia® FX-635™

Placebo Laser

Arm Description

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.

The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 1, 2015
Last Updated
March 14, 2022
Sponsor
Erchonia Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02461225
Brief Title
Study of Low Level Laser Therapy to Treat Diabetic Peripheral Neuropathy Foot Pain
Official Title
A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia® FX-635™ on Diabetic Peripheral Neuropathy Foot Pain Clinical Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erchonia® FX-635™
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Laser
Arm Type
Placebo Comparator
Arm Description
The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light.
Intervention Type
Device
Intervention Name(s)
Erchonia® FX-635™
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo Laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in Pain Rating on the Visual Analog Scale (VAS)
Description
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.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Zang, DPN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Institute of Footcare Physicians
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85204
Country
United States
Facility Name
Midleton Foot Clinic
City
Midleton
State/Province
Co. Cork
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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