An Evaluation of the Effect of Low Level Laser Therapy on Diabetic Peripheral Neuropathy Pain

NCT04006392 | Terminated Results FDA Device

• 1 other identifier: EC_DPN2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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)

• Participants With a 30% or Greater Change in Visual Analog Scale (VAS) Pain Scores

  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. For the primary study outcome, the percent change in the VAS pain score recorded at baseline and endpoint is calculated for each subject. Individual subject success is a 30% or greater change in VAS pain scores. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success is defined as a 35% or greater difference between the proportion of individual successes in each treatment group.

  Baseline and 6 weeks

Study Arms (2)

Erchonia FX-635

EXPERIMENTAL

The Erchonia FX-635 is administered to the foot 12 times over 6 weeks (2 times each week) for 15 minutes per foot.

Device: Erchonia FX-635

Placebo Laser

SHAM COMPARATOR

Noise and appearance of output is the same but no active therapy applied. Treatment administration procedure is the same as with the experimental arm.

Device: Placebo Laser

Interventions

Erchonia FX-635 DEVICE

The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices.

Erchonia FX-635

Placebo Laser DEVICE

Non-therapeutic output.

Placebo Laser

Eligibility Criteria

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

You may qualify if:

• years of age or older. Significant spontaneous pain of 50 or greater on the 0-100 VAS for the feet overall.
• Existing clinical diagnosis of diabetes induced Peripheral Neuropathy.
• Significant spontaneous foot pain that occurs comparably bilaterally.
• Foot pain is chronic, ongoing for at least 3 months, bilaterally.
• Subject has been on a stable anti-diabetic medication regimen or on no anti-diabetic medication regimen for the prior 30 days.
• Subject has not used or is willing to abstain from using analgesics within 7 days prior to study start.
• Subject has been on a stable dosage of antidepressants for at least 90 days prior to study start and is willing and able to maintain that stable dosage throughout study participation OR subject has not used or is willing to abstain from using antidepressants for 30 days prior to study start.
• Subject has been on a stable dosage of any of Neurontin, Lyrica, Tramadol and Opioid medicines such as Ultram and Ultracet for at least 90 days prior to study start and is willing and able to maintain that stable dosage throughout study participation OR subject has not used or is willing to abstain from using any of the these medications for 30 days prior to study start.
• Subject has not received or is willing to abstain from receiving any injections of local anesthetics such as lidocaine within 30 days prior to study start.
• Subject is able and willing to take over-the-counter Regular Strength Tylenol tablets to manage pain, as needed, throughout the study.
• Subject is willing and able to refrain from consuming any over-the-counter and/or prescription medications including muscle relaxants and/or herbal supplements and/or recreational and medical drugs including cannabis intended for the relief of pain and/or inflammation throughout study participation, except for the study-specific pain relief medication of over-the-counter Tylenol.
• Subject is willing and able to refrain from engaging in any non-study procedure therapies for the management of foot pain throughout the study, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.
• Can communicate fluently in English and can read and write English sufficiently to comply with the study procedures and complete the information in the Subject Diary.

You may not qualify if:

• Subject's foot pain is undiagnosed, or has been diagnosed as being other than, or in addition to, diabetes induced Peripheral Neuropathy.
• Subject's foot pain is unilateral or notably different between the two feet.
• Serious organ disease or other serious primary disease merger.
• Diabetes ketosis, ketoacidosis or severe infection within the past two weeks.
• Current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis, peripheral vascular disease.
• Cancer or treatment for cancer in the past 6 months.
• 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 areas to be treated with the laser.
• 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 informed consent form and/or ability to record the necessary study measurements.
• Any condition or other variable that in the opinion of the investigator may confound or interfere with the evaluation of the effectiveness of the investigational treatment or otherwise render the subject unable to comply with the requirements of the study protocol.
• Involvement in litigation and/or receiving disability benefits related in any way to the parameters of the study.
• Participation in a clinical study or other type of research in the past 30 days.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (4)

Arizona Institute of Footcare Physicians

Mesa, Arizona, 85204, United States

Location

Jeffrey Kleis, DPM

Costa Mesa, California, 92626, United States

Location

Hialeah Hospital Medical Plaza

Hialeah, Florida, 33139, United States

Location

Jordan Steinberg, DPM

Florham Park, New Jersey, 07932, United States

Location

Results Point of Contact

• Title: Clinical Affiairs
• Organization: Erchonia Corporation

tsammons@erchonia.com

888.242.0571

Study Officials

• Sandra L Franco, DPM

  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: July 1, 2019
• First Posted: July 5, 2019
• Study Start: February 15, 2019
• Primary Completion: October 5, 2021
• Study Completion: October 5, 2021
• Last Updated: March 14, 2023
• Results First Posted: March 14, 2023

Record last verified: 2023-02

Locations

US (4)