Neuropathy
Conditions
Brief summary
This study is to see if applying red and violet low-level laser light can help to reduce foot pain associated with diabetic peripheral neuropathy,
Detailed description
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, when used at home by non-medical professionals.
Interventions
DEVICEErchonia EVRL
42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks.
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously diagnosed with diabetes-induced Peripheral Neuropathy by a qualified health Physician. * Over the age of 18 years of age * Able to read and write English. * Constant feet pain on-going over at least the past 3 months. * Subject is willing and able to refrain from consuming any OTC 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 OTC Tylenol. * Subject is willing and able to refrain from engaging in any non-study procedure therapies for the management of 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. * Self-reported foot pain on the Numerical Rating Scale (NRS) is 50 or greater
Exclusion criteria
* Pregnant or think you might be pregnant. * Open wounds (sores, cuts, ulcers, etc) around the feet * Cancerous growths around the feet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Numerical Rating Scale (NRS) | Baseline and 3 week | The Numerical Rating Scale (NRS) assesses the level or degree of pain. With '0: no pain at all' and '100: worst pain imaginable. The subject will be asked to rate the level of foot pain he or she is experiencing at that time. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erchonia EVRL 635 nanometers (nm) and 405 nm laser application
Erchonia EVRL: 42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Erchonia EVRL | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 5 Participants | — |
| Duration of Feet Pain | 6.5 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Change in Pain Numerical Rating Scale (NRS)
The Numerical Rating Scale (NRS) assesses the level or degree of pain. With '0: no pain at all' and '100: worst pain imaginable. The subject will be asked to rate the level of foot pain he or she is experiencing at that time.
Time frame: Baseline and 3 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia EVRL | Change in Pain Numerical Rating Scale (NRS) | 43.75 units on a scale | Standard Deviation 20.98 |