Diabetic Peripheral NeuropathyNCT02461225
Study of Low Level Laser Therapy to Treat Diabetic Peripheral Neuropathy Foot Pain
A study testing Erchonia® FX-635™ in people with Diabetic Peripheral Neuropathy, run by Erchonia Corporation at 2 sites in 2 countries.
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
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2016to 30 Sep 2017
- 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
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
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 Foot Pain Clinical Study Protocol
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
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.
- 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-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.
Placebo LaserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Change in Pain Rating on the Visual Analog Scale (VAS)
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.
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 posted3 Jun 2015 (estimated)
- Study start1 Mar 2016
- Primary completion1 Jul 2017
- Study completion30 Sep 2017
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerry Zang, DPN, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461225
- Sponsor's protocol ID
- EC_DPN
- Status last verified
- Mar 2022
- First submitted
- 1 Jun 2015
- Last updated
- 15 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. 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 Foot Pain Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT02461225
- Acronym / sponsor ID
- EC_DPN
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 15 Mar 2022
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
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
- 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™ | Active comparator | Device: 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. |
| Placebo Laser | Placebo comparator | Device: Placebo LaserThe Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
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-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. | Device | Erchonia® FX-635™ |
| Placebo LaserThe 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. | Device | Placebo Laser |
Primary outcome
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Time frame: 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.
1 secondary outcome
Change in Pain Rating on the Visual Analog Scale (VAS)
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kerry Zang, DPN principal investigator
2 sites in 2 countries: 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 2 sites in 2 countries.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ireland. 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 15 Mar 2022). 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?
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) (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 15 Mar 2022.