Diabetic Peripheral NeuropathyNCT04006392
An Evaluation of the Effect of Low Level Laser Therapy on Diabetic Peripheral Neuropathy Pain
A study testing Erchonia FX-635 in people with Diabetic Peripheral Neuropathy, run by Erchonia Corporation at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Erchonia FX-635
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Feb 2019to 5 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Jeffrey Kleis, DPM
Costa Mesa, California, 92626
Jordan Steinberg, DPM
Florham Park, New Jersey, 07932
Hialeah Hospital Medical Plaza
Hialeah, Florida, 33139
Arizona Institute of Footcare Physicians
Mesa, Arizona, 85204
About this study
Official title: A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia® FX-635™ on Diabetic Peripheral Neuropathy Pain
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.
Read the detailed description
Peripheral neuropathy is one of the most common chronic diseases and a leading cause of adult disability in the U.S. Diabetic neuropathy represents over a third of all neuropathies, making diabetes the leading cause of peripheral neuropathy, affecting about 15-18 million Americans.
Living with neuropathy can cause tremendous frustration and social isolation. The daily chronic pain impacts day-to-day functionality resulting in physical and psychological problems including impaired concentration, anxiety, depression, a decline in cognitive abilities, and sleep difficulties which in turn can lead to irritability and increased pain sensitivity. Additionally, the economic burden from medical costs and workplace productivity losses are high and on the rise as the incidence of peripheral neuropathy increases.
Peripheral neuropathy describes damage to the peripheral nervous system that interferes with vital nerve connections, distorting and sometimes interrupting messages between the brain and the rest of the body. Diabetic peripheral neuropathy is a chronic acquired form of nerve damage that can occur in individuals with diabetes wherein the primary cause is damage to nerve fibers and blood vessels from prolonged exposure to high blood sugar (glucose). While the precise mechanism for this damage remains unclear, a combination of factors likely plays a role, including the complex interaction between nerves and blood vessels. High blood glucose interferes with the ability of the nerves to transmit signals and weakens the walls of the small blood vessels (capillaries) that supply the nerves with oxygen and nutrients.
The primary and most debilitating symptom of diabetic peripheral neuropathy is a sensation of tingling, prickling, buzzing, pinching, burning, and/or sharp jabbing stabbing pain in the feet. Nerve pain from diabetic peripheral neuropathy can be severe, constant, and difficult to treat. Current therapies include an array of over-the-counter and prescription medications or alternative treatment options such as injections or patches of local anesthetics; surgical destruction of nerves; implantation of a device to relieve pain; transcutaneous electrotherapy (TENS); hand or foot braces and orthopedic shoes.
Low Level Laser Therapy (LLLT) communicates information to the receptors on the membrane of the cell and mitochondrion (the enzymatic engine of the cell). This energetic information reaches the cell's DNA, which directly controls cell function. When the cells receive better information, they work better, as do the tissues they comprise, like bones, cartilage, tendons, ligaments, etc. In this way, LLLT promotes the healing and regeneration of damaged tissues, having both local effects on tissue function and also systemic effects carried throughout the body by the blood and acupuncture meridians.
The key basic physiological effects of low level laser light include increased cell membrane polarization and permeability; Adenosine-5-triphosphate (ATP) production and respiratory chain activity; enzyme activity; collagen and epithelial production; capillary formation; macrophage (immune) activity; analgesic effects due to elevated endorphin production, electrolytic nerve blockage, and improved blood and lymph flow; anti-inflammatory effect due to improved circulation and accelerated tissue regeneration; and increased production of antioxidants. Of additional benefit is that light energy from low level lasers will only be absorbed by cells and tissues that are not functioning normally and has no effect on healthy cells.
Therefore, low level laser therapy has the potential benefit of providing an effective means of reducing low back pain that is simple, quick, non-invasive and side-effect free.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Erchonia FX-635, Placebo Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia FX-635Device
The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices.
Placebo LaserDevice
Non-therapeutic output.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Feb 2019
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Why it stopped: Unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra L Franco, DPM, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006392
- Sponsor's protocol ID
- EC_DPN2
- Status last verified
- Feb 2023
- First submitted
- 1 Jul 2019
- Last updated
- 14 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia® FX-635™ on Diabetic Peripheral Neuropathy Pain
- ClinicalTrials.gov ID
- NCT04006392
- Acronym / sponsor ID
- EC_DPN2
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 14 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Peripheral neuropathy is one of the most common chronic diseases and a leading cause of adult disability in the U.S. Diabetic neuropathy represents over a third of all neuropathies, making diabetes the leading cause of peripheral neuropathy, affecting about 15-18 million Americans.
Living with neuropathy can cause tremendous frustration and social isolation. The daily chronic pain impacts day-to-day functionality resulting in physical and psychological problems including impaired concentration, anxiety, depression, a decline in cognitive abilities, and sleep difficulties which in turn can lead to irritability and increased pain sensitivity. Additionally, the economic burden from medical costs and workplace productivity losses are high and on the rise as the incidence of peripheral neuropathy increases.
Peripheral neuropathy describes damage to the peripheral nervous system that interferes with vital nerve connections, distorting and sometimes interrupting messages between the brain and the rest of the body. Diabetic peripheral neuropathy is a chronic acquired form of nerve damage that can occur in individuals with diabetes wherein the primary cause is damage to nerve fibers and blood vessels from prolonged exposure to high blood sugar (glucose). While the precise mechanism for this damage remains unclear, a combination of factors likely plays a role, including the complex interaction between nerves and blood vessels. High blood glucose interferes with the ability of the nerves to transmit signals and weakens the walls of the small blood vessels (capillaries) that supply the nerves with oxygen and nutrients.
The primary and most debilitating symptom of diabetic peripheral neuropathy is a sensation of tingling, prickling, buzzing, pinching, burning, and/or sharp jabbing stabbing pain in the feet. Nerve pain from diabetic peripheral neuropathy can be severe, constant, and difficult to treat. Current therapies include an array of over-the-counter and prescription medications or alternative treatment options such as injections or patches of local anesthetics; surgical destruction of nerves; implantation of a device to relieve pain; transcutaneous electrotherapy (TENS); hand or foot braces and orthopedic shoes.
Low Level Laser Therapy (LLLT) communicates information to the receptors on the membrane of the cell and mitochondrion (the enzymatic engine of the cell). This energetic information reaches the cell's DNA, which directly controls cell function. When the cells receive better information, they work better, as do the tissues they comprise, like bones, cartilage, tendons, ligaments, etc. In this way, LLLT promotes the healing and regeneration of damaged tissues, having both local effects on tissue function and also systemic effects carried throughout the body by the blood and acupuncture meridians.
The key basic physiological effects of low level laser light include increased cell membrane polarization and permeability; Adenosine-5-triphosphate (ATP) production and respiratory chain activity; enzyme activity; collagen and epithelial production; capillary formation; macrophage (immune) activity; analgesic effects due to elevated endorphin production, electrolytic nerve blockage, and improved blood and lymph flow; anti-inflammatory effect due to improved circulation and accelerated tissue regeneration; and increased production of antioxidants. Of additional benefit is that light energy from low level lasers will only be absorbed by cells and tissues that are not functioning normally and has no effect on healthy cells.
Therefore, low level laser therapy has the potential benefit of providing an effective means of reducing low back pain that is simple, quick, non-invasive and side-effect free.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erchonia FX-635 | Experimental | Device: Erchonia FX-635The Erchonia FX-635 is administered to the foot 12 times over 6 weeks (2 times each week) for 15 minutes per foot. |
| Placebo Laser | Sham comparator | Device: Placebo LaserNoise and appearance of output is the same but no active therapy applied. Treatment administration procedure is the same as with the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erchonia FX-635The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices. | Device | Erchonia FX-635 |
| Placebo LaserNon-therapeutic output. | Device | Placebo Laser |
Primary outcome
Participants With a 30% or Greater Change in Visual Analog Scale (VAS) Pain Scores
Time frame: 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. 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra L Franco, DPM principal investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia FX-635 in people with Diabetic Peripheral Neuropathy, run by Erchonia Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With a 30% or Greater Change in Visual Analog Scale (VAS) Pain Scores (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.