Study of Low Level Laser Therapy to Treat Diabetic Periph... | NCT02461225

NCT02461225

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Device: Placebo Laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline and 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Name	Affiliation	Role
Kerry Zang, DPN		Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Institute of Footcare Physicians		Mesa	Arizona	85204	United States
Midleton Foot Clinic

Arm/Group Information

ID	Title	Description
FG000	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. 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.
FG001	Placebo Laser	The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. Placebo Laser: 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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. 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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Number

participants

Baseline and 6 weeks

ID	Title	Description
OG000	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. 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. 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.