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

NCT02461225 | Completed Results FDA Device

• 1 other identifier: EC_DPN
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Pain Rating on the Visual Analog Scale (VAS)

  Baseline and 6 weeks

Study Arms (2)

Erchonia® FX-635™

ACTIVE COMPARATOR

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™

Placebo Laser

PLACEBO COMPARATOR

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

Device: Placebo Laser

Interventions

Erchonia® FX-635™ DEVICE

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.

Erchonia® FX-635™

Placebo Laser DEVICE

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.

Placebo Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (2)

Arizona Institute of Footcare Physicians

Mesa, Arizona, 85204, United States

Location

Midleton Foot Clinic

Midleton, Co. Cork, Ireland

Location

Results Point of Contact

• Title: Elvira Cawthon
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

6154475150

Study Officials

• Kerry Zang, DPN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: March 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 30, 2017
• Last Updated: March 15, 2022
• Results First Posted: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IE (1)