Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks

Treatments for diabetic neuropathy includes a systematic, stepwise approach that entails glycemic control and control of metabolic syndrome, symptomatic treatment of pain, and counseling on foot care and safety measures.

Unlike compression products, the semiconductor embedded socks increase blood circulation through activation of the elements with heat of the body, and releases mid and far infrared waves as well as negative ions. Both infrared waves and negative ions are biologically active and mediate inflammatory and pain pathways in the body. The technology has also been shown to increase blood speed and blood flow. The technology has also been shown to:

• Increase blood flow and velocity
• Reduce osteoarthritis pain
• Reduce effusion post total knee arthroplasty
• Improve chondrogenic differentiation in vitro
• Improve muscle recovery
• Increase circulation by up to 22% at rest
• Improve functional outcomes

The benefits of the Infrared Wave and Negative Ion therapy include:

• Inhibition of Cox-2 and Prostaglandins in the lipopolysaccharide (LPS)-moderated pain pathway
• Up-regulation of heat shock protein
• Mediated Nitric oxide production
• Increased activity of voltage-gated ion channels
• Increased activity of mechanosensitive ion channels
• Polarization of cell surface membranes
• Protecting muscle damage
• Scavenging of Reactive Oxygen Species (ROS)
• Improved thermoregulation

To date, studies have shown that the semiconductor embedded fabric increase circulation by up to 22% at rest, and have shown powerful results in reducing inflammation, swelling, improving range of motion in the knee post-surgery, and providing pain relief.

The semiconductor embedded fabric emits mid-level and far infrared waves and negative ions. Delivery of infrared waves and negative ions to the tissue increases blood flow, facilitates the anti-inflammatory nitric oxide (NO) cascade by accelerating the binding of calcium (Ca2+) to calmodulin (CaM). NO provides several healing factors to the body as a vasodilator, increasing blood and lymphatic flow. Additionally, NO down-regulates interleukin-1 beta (IL1β) and inducible nitric oxide synthase (iNOS) in certain cell types, which leads to reduced cyclooxygenase-2 (COX-2) and prostaglandins - molecules responsible for causing inflammation and pain. Unlike other systemic COX-2 inhibitors such as nonsteroidal anti-inflammatory drugs (NSAIDs), targeted infrared and negative ion therapy stimulate localized reaction pathways, thereby reducing pain and inflammation.

This study seeks to identify patient reported outcomes for management of Diabetic Neuropathy with semiconductor embedded fabric in the affected area.

Inclusion criteria

• Patients diagnosed with mild to moderate Diabetic Neuropathy with a score between 2 and 7 out of 10 on the MNSI upon clinical examination and assessment.
• Patients reporting symptoms of Diabetic Neuropathy
• Patients age 18-79
• Patients who are willing and able to adhere to follow-up schedule and protocol guidelines
• Patients who are willing and able to sign corresponding research subject consent form

Exclusion criteria

• Patient has a history of neurodegenerative conditions, including multiple sclerosis or Parkinson's disease
• Patient has chronic pain conditions unrelated to diabetic neuropathy, including spinal stenosis, low back pain, and sciatica
• Patient has auto-immune or auto-inflammatory diseases other than Diabetic Neuropathy, including Multiple Sclerosis or Lyme Disease
• Patient has experienced a stroke
• Patient has any type of paralysis
• Patients with a score less than 2 and greater than 7 out of 10 on the MNSI upon clinical examination and assessment
• Patient has severe peripheral artery disease (with an ankle brachial index of <0.7)
• Patient has chronic venous insufficiency (greater than stage 4)
• Patient has used tobacco within the last 90 days
• Patient has an open wound at the area of application
• Patient has started a new medication for diabetic neuropathy symptoms within the past 90 days
• Patient is not within the ages of 18-79
• Patient is unwilling or unable to sign the corresponding research subject consent form
• Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results