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

• Sponsor: Erchonia Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02461225
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site: 15
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Peripheral Neuropathy	Device: Erchonia® FX-635™; Device: Placebo Laser	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Sep 30, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Institute of Footcare Physicians	Mesa	Arizona	United States	85204
2	Midleton Foot Clinic	Midleton	Co. Cork	Ireland

Sponsors and Collaborators

• Erchonia Corporation

Investigators

• Principal Investigator: Kerry Zang, DPN,

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jan 12, 2016

More Information

Publications

None provided.

• Responsible Party: Erchonia Corporation
• ClinicalTrials.gov Identifier: NCT02461225
• Other Study ID Numbers: EC_DPN
• First Posted: Jun 3, 2015
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies

Study Results

Participant Flow

Arm/Group Title	Erchonia® FX-635™	Placebo Laser
Arm/Group 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. 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.	The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. 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.
Period Title: Overall Study
STARTED	19	11
COMPLETED	19	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Erchonia® FX-635™	Placebo Laser	Total
Arm/Group 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. 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.	The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. 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.	Total of all reporting groups
Overall Participants	19	11	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.83 (13.19)	53.45 (11.26)	51.24 (12.56)
Sex: Female, Male (Count of Participants)
Female	12 63.2%	5 45.5%	17 56.7%
Male	7 36.8%	6 54.5%	13 43.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 21.1%	2 18.2%	6 20%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 10.5%	2 18.2%	4 13.3%
White	13 68.4%	7 63.6%	20 66.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Ireland	19 100%	11 100%	30 100%
Visual Analog Scale Pain Rating (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	68.89 (12.49)	65.91 (10.69)	67.88 (11.99)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia® FX-635™	Placebo Laser
Arm/Group 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. 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.	The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. 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.
Measure Participants	19	11
Number [participants]	18 94.7%	4 36.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erchonia® FX-635™, Placebo Laser
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.0005
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia® FX-635™	Placebo Laser
Arm/Group 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. 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.	The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. 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.
Measure Participants	19	11
Mean (Standard Deviation) [score on a scale]	-60.97 (23.28)	-9.09 (34.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erchonia® FX-635™, Placebo Laser
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	5 months
Arm/Group Title	Erchonia® FX-635™		Placebo Laser
Arm/Group 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. 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.		The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. 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.
All Cause Mortality
	Erchonia® FX-635™		Placebo Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/11 (0%)
Serious Adverse Events
	Erchonia® FX-635™		Placebo Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Erchonia® FX-635™		Placebo Laser
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.