Laser Therapy for Diabetic Peripheral Neuropathic Pain

The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy
of a course of laser therapy on peripheral neuropathic pain in persons with diabetes.
Participants will be assessed at baseline, post-intervention, and 3-months followup, and the
study will consist of two treatment arms, including: (a) twice-per-week laser treatment for
4 weeks and once-per-week laser treatment for 8 weeks or (b) same treatment schedule sham
(or placebo) for 12 weeks. Additionally, the study will examine inflammatory markers,
functional status, and quality of life.

Specific Aim 1. Change from baseline in self-reported pain in a sample of adults with
diabetes at their last visit and at 3 months. Hypothesis 1: The laser therapy will produce
significant improvement at post-intervention and three-month followup on measures of
self-reported pain among adults with diabetes. Specific Aim 2: Decrease biochemical markers
of inflammation by investigating levels of cytokines. Hypothesis 2: The laser therapy will
produce significant improvement at post-intervention and three-month followup on levels of
inflammatory markers.Specific Aim 3: Improve quality of life. Hypothesis 3: The laser
therapy will produce significant improvement at post-intervention and three-month followup
on quality of life.No substantial psychological, medical, or social risks exist to the
participants, other than minor discomfort associated with the venipuncture.

Although all measures to protect confidentiality will be put in place, the possibility
exists that electronic data could be jeopardized. In the remote case that such event occurs,
it will be immediately reported to the IRB.The proper use of the LiteCure LightForce FX
Therapy Laser class IV laser therapy device should be harmless and presents no different
risks than similar laser therapy devices currently on the market. At the time of this
submission, no serious adverse events have been reported to the company or the regulatory
authority by consumers. All study personnel will complete detailed training in the use of
the device and will follow the directions of the manufacturer for operating the device; all
instructions for use of the device will be followed for each subject.

As reported by LiteCure Medical the LiteCure LightForce FX therapy laser device has been
cleared by the FDA, tested according IEC electrical safety standards for medical devices,
and manufactured in an ISO13485 compliant facility. These certifications ensure that
LiteCure Medical devices are manufactured in state of the art facilities, under strict
quality control, and environmental protection standards. Participants will incur no
additional appreciable psychological or social risks by participating in this study. The
process of interviewing during the assessment may cause discomfort. Discomfort or fatigue
may also be experienced in completing the assessment battery.

The information obtained in this study will help in determining the efficacy of using a
class IV laser therapy device for neuropathic pain, inflammation, and quality of life in
persons with diabetic distal symmetric peripheral neuropathy. By participating in the study,
subjects may feel less pain, have lower inflammation, and experience improved quality of
life. The minimal risk of participating in this study is reasonable because of the potential
benefit gained in pain status, inflammatory status, and quality of life.

Inclusion Criteria:

1. Is age 18 or older

2. Has diabetes

3. Has chronic, unresolved neuropathic pain of the feet for more than 3 months

4. able to attend the treatment schedule on-campus for the period of the intervention

5. Is willing to provide informed consent to participate in study

Exclusion Criteria:

1. Has any chronic open wounds on your back or bottom of the feet

2. Is pregnant

3. Diagnosed with schizophrenia, other psychotic disorders, bipolar disorder, major
depression with psychotic features, delirium, or alcohol or substance
abuse/dependence

4. Diagnosed with a bleeding disorder

5. Diagnosed with aphasia or sensory, motor, or visual disturbances that could interfere
with assessments

6. Diagnosed with any major pulmonary, renal, thyroid, hepatic, gastrointestinal, or
seizure conditions

7. Had any hematologic or ontological disorders treated with chemotherapy in the
previous two years

8. Is currently undergoing any chemotherapy or radiation treatment for cancer

9. Has had more than three major medical or psychiatric hospitalizations in the past
year

10. Has been diagnosed with a terminal illness

11. Is you currently participating in another trial with drugs, dietary supplements, or
medical treatment that affects neuropathic pain

12. Is currently taking any opioid or other pain medication

13. Is currently taking any pain-relieving nutritional supplement, herb, antioxidants or
integrative medicine for diabetic neuropathy

14. Is currently taking prescription or over-the-counter pain relievers