Erchonia Corporation is currently recruiting for a study on the effect of Low Level Laser Therapy on Diabetic Peripheral Neuropathy pain. This study can be found at ClinicalTrials.gov here .
PURPOSE OF THE STUDY
In this study, the Sponsor, Erchonia Corporation, and investigators are studying the use of a device called the Erchonia® FX-635™ that gives off low level laser light. This study is to see if using the Erchonia® FX-635™ can help to reduce foot pain in people with diabetic peripheral neuropathy. The Erchonia® FX-635™ is cleared for marketing by the U.S. Food and Drug Administration (FDA) as an adjunct to reducing chronic heel pain arising from plantar fasciitis and as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin. However; its use in this study is investigational, as the FX-635™ has not been cleared for market by the FDA for reducing foot pain in individuals with diabetic peripheral neuropathy.
If you agree to take part in this study, you will be one of about 64 people taking part. This is a randomized, double-blind, placebo-controlled study. This means that if you choose to take part in this study, it will be determined by chance (like the flip of a coin) whether you will get the active study treatment or the placebo study treatment. If chosen to the placebo group you will have an option for active treatments following the “unblinding” of the study.
To take part in this study, you must agree to not take any medicines or try any other treatments to help with your foot pain, until your part in the study is over. You may take over-the-counter Tylenol according to the directions for use on the labeling to help with your foot pain while in the study, if you need to.
There are 12 treatments with the Erchonia® FX-635™, twice weekly for six weeks. Each treatment lasts 30 minutes, 15 minutes for each foot. You will sit comfortably with your foot elevated, and the Erchonia FX-635™ will be directed at 3 points on your foot. The laser light will shine on your foot, but it will not touch your skin. You will wear protective glasses to block out the laser light.
RISKS AND DISCOMFORTS
There have been other research studies using Erchonia low level light lasers. In these studies, no serious medical events resulted from use of the study device. The only known or anticipated risk with the use of the laser study device is that long-term exposure to laser light could cause damage to your eyesight. As a precaution, when you are given the treatments with the FX-635™, you will be fitted with special darkened protective glasses to block out the light. However, there may be unknown risks to using the laser study device with this study treatment such as skin irritation, discoloring, rash, indentations and infection. There may be side effects that are not known at this time. It is possible that you will not get any improvement in your foot pain, or that it may even get worse.
It will not cost you anything to be part of the study. Erchonia Corporation, the sponsor of this research, will provide the treatments with the Erchonia FX-635™ free of charge during this study. The cost for all study related procedures and measurements will also be covered by Erchonia Corporation. Nothing will be billed to you or to your insurance company.
To be eligible for study participation, a subject must satisfy each of the following criteria.
- Significant spontaneous pain of 50 or greater on the 0-100 VAS for the feet overall.
- 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
- Foot pain is chronic, defined as having been ongoing for at least 3 months, bilaterally.
- Subject has been on a stable anti-diabetic medication regimen for the prior 30 days or on no anti-diabetic medication regimen for the prior 30 days.
- Subject has not used or is willing to abstain from using any one or more of the following analgesics, or an equivalent, within 7 days prior to initiation of the study procedure administration with the Erchonia® FX-635™:
- OTC NSAIDs (nonsteroidal anti-inflammatory drugs) such asaspirin, ibuprofen (Advil, Motrin) and naproxen (Aleve),
- prescription NSAIDs such as Celebrex, Lodine and Relafen
- Subject has been on a stable dosage of any of the following antidepressants or any equivalent agent for at least 90 days prior to initiation of the study procedure administration with the Erchonia® FX-635™ 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 following antidepressants or any equivalent agent for 30 days prior to initiation of the study procedure administration with the Erchonia FX-635™:
- Tricyclic antidepressants (TCAs)such as Elavil, Pamelor and Norpramin; amitriptyline
- Selective serotonin reuptake inhibitors (SSRIs) such as Paxil, paroxetine, fluoxetine (Prozac)
- clomipramine (Anafranil)
- desipramine (Norpramin)
- Subject has been on a stable dosage of any of the following prescription medications or any equivalent agents for at least 90 days prior to initiation of the study procedure administration with the Erchonia FX-635™ 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 following prescription medications or any equivalent agents for 30 days prior to initiation of the study procedure administration with the Erchonia FX-635™:
- Opioid medicines such as Ultram and Ultracet
- Subject has not received or is willing to abstain from receiving any injections of local anesthetics such as lidocaine within 30 days prior to initiation of the study procedure administration with the Erchonia FX-635™.
- Subject is able and willing to take over-the-counter Regular Strength Tylenol® tablets to manage his or her pain, as needed, throughout the course of study participation.
- 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 the course of 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 his or her foot pain throughout the course of study participation, 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.
- Subject agrees to refrain from taking a dosage of the study rescue pain medication of over-the-counter Regular Strength Tylenol® tablets for at least 6 hours before a scheduled VAS foot pain rating is to be recorded. The subject understands that he may take a dosage of the over-the-counter Regular Strength Tylenol® tablets right after the VAS rating has been recorded, if needed to manage foot pain.
- Subject agrees and is able to complete the Subject Diary, as applicable.
- 18 years of age or older.
- Subject is able to communicate fluently in English with the investigator and is able to read and write English sufficiently to comply with the study procedures and complete the information in the Subject Diary.
A subject who satisfies any of the following criteria will be excluded from study participation:
- Subject’s foot pain is undiagnosed, or has been diagnosed by a qualified medical professional, as being other than, or in addition to, diabetes induced Peripheral Neuropathy (such as due to drugs, poisoning, cancer or genetic conditions).
- Subject’s foot pain is unilateral or notably different between the two feet (such that the pain in one foot is notably lesser/greater than in the other).
- 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.
SITE CONTACT INFORMATION
If you have any other questions regarding this study or company, please contact Erchonia Clinical Affairs Manager, Travis Sammons, at 888-242-0571 ext. 511 or firstname.lastname@example.org .