Clinical trial NCT02461225: Study of Low Level Laser Therapy to Treat Diabetic Peripheral Neuropathy Foot Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in Pain Rating on the Visual Analog Scale (VAS)
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Institute of Footcare Physicians
state: Arizona
city: Midleton
country: Ireland
facility: Midleton Foot Clinic
state: Co. Cork
Study officials:
name: Kerry Zang, DPN
role: PRINCIPAL_INVESTIGATOR
References: