Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
This is a double blind, randomized, placebo-controlled study in which a total of 120 patients will be selected from a broad spectrum group of typical Americans (all demographics including various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients will meet inclusion and/or exclusion criteria.

Detailed Description
-----------------
This is a double blind, randomized, placebo-controlled study in which a total of 120 patients will be selected from a broad spectrum group of typical Americans (all demographics including various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients will meet inclusion and/or exclusion criteria. Randomization and Application of HL Device The placebo controlled group of 60 patients will be randomized from the group of 120 patients by one designee who selects the placebo vs treatment groups based on acceptable statistical standards for determining placebo vs treatment arms of research studies. There will be two different HL Devices. There will be the HL-NIR device that includes NIR diodes and performs Near Infrared therapy and an identical appearing second device, the HL-SHAM device, that is used as the placebo device and although appearance is identical, this device does not perform Near Infrared treatment. Both placebo group and treatment group subjects will have the NIR or sham device applied to both lower extremities for a short duration three times a week over the course of several weeks.

Official Title
-----------------
Randomized Double-Blind Study of the Efficacy of Near Infrared Phototherapy on Sensation and Pain in Type 2 Diabetic Neuropathy

Conditions
-----------------
Neuropathy

Intervention / Treatment
-----------------
* Other: Infrared Phototherapy
* Other: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Type 2 Diabetes Mellitus on oral hypoglycemic medication, and/or injectable insulin Hg A1C 5.7 or above ((Pre-Diabetes is 5.7 to 6.4%) (Diabetes is above 6.5%)), Hg A1C below 9.1 Peripheral Neuropathy of the feet, or feet and legs If the patient has a lower extremity ulceration that is not showing any signs of infection, and this patient has ABPI and TBPI above 55 mm of Hg, they may be included in the study, at the discretion of the Principal Investigator (PI). If the patients infection is localized (not osseous in nature) and the infection can be treated and cleared and remain uninfected for 30 days, the patient could be reevaluated and included in the study at the discretion of the PI. If the patient has an area of injury or erythema or induration, they may still be included in the study if they have ABPI and TBPI above 55 mm of Hg, at the discretion of the PI Positive MNS All medications or other treatments for neuropathy are held constant for at least 30 days prior to the study, during the baseline and treatment period of the study. Subjects will have pain and insensate sites on each foot (both feet will be assessed and pain scales for both extremities will be measured/followed). Moderately positive MNS score. Exclusion Criteria: Any other causes of Peripheral Neuropathy Known Spinal Stenosis Previous Back Injury Comorbid issues of exacerbated CHF Exacerbation of COPD Chronic steroid use Underlying connective tissue disease Previous trauma or underlying fracture Current injury or trauma Skin ulceration ABPI and TBPI measurements will be measured and if the patient has an open ulceration with signs of infection and the wound is weeping any serous or purulent fluid, anywhere on their foot or lower extremity Negative MNS Previous amputation of a portion of the foot Amputation of digit or digits are not considered exclusion criteria Previous arterial bypass graft Known cardiac arrhythmia HG A1C above 9.1% Uncontrolled fasting blood sugar, or Type 1 Diabetes. If on any anti-epileptic or anti-depressant medications If patient has had any change in pain or anti-inflammatory medication anytime within the past 30 days. Pregnancy or planned pregnancy (If a patient has begun our research study and does not know that they are pregnant or they become pregnant during the study, they will not be dropped from the study) (Reasoning: there is no evidence for or against using HealthLight therapy in pregnant individuals.) Active osteomyelitis or positive for osteomyelitis within the past six months Open ulceration with signs and symptoms of active infection. Known Peripheral Arterial Disease (PAD) Previous Lumbar surgery or Lumbar Disc intervention anytime within the past year

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: HL-Sham<br>The placebo device (also referred to as the HL-SHAM device) will have an identical appearance to the HL-NIR device. Though the HL-NIR device will be applied, there will be no treatment administered. | Other: Sham<br> <br> |
| Experimental: HL-NIR<br>The device referred to as the HL-NIR device includes both a podiatric or foot and leg component, similar to a loose fitting boot, that is easily applied to all subjects (one size fits all). Application of the device is snug but comfortable without risk for constriction of soft tissue. | Other: Infrared Phototherapy<br>* Subjects will wear a cuff on their extremities for a set period of time at set intervals over a period of several weeks. The cuff will emit the Infrared Phototherapy treatment (or sham if randomized to the non-treat group).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Pain (MPI Pain Scale) | Decrease in pain as measured by the Multidimensional Pain Inventory (MPI) pain scale | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Sensation | Improvement in sensation as measured by Michigan Neuropathy Screening (MPS) scoring | 90 Days |