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

Diabetic Neuropathy Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

Distal symmetric polyneuropathy, also known as diabetic neuropathy, is the most common neurological complication of diabetes and a main cause of morbidity. The condition leads to gradual loss of function of the longest nerve fibers that limits function and decreases quality of life. Symptoms present distally and symmetrically in toes and feet. Symptoms of the neurologic disability include sensory loss, risk of foot ulcers and limb amputations and pain. The condition is not generally considered reversible, and condition management aims to slow progression and prevent complications.

According to estimates from the International Diabetes Federation, diabetic neuropathy affected approximately 425 million people in 2017, with projections indicating a rise to 628 million by 2045. Despite the high prevalence of this condition, it is commonly misdiagnosed and has limited treatment options. There are multiple phenotypes of diabetic neuropathy, with the most common form being distal symmetric sensorimotor polyneuropathy, which is what we will be focusing on in this study.

The proposed study seeks to evaluate the effectiveness of a non-compressive therapeutic socks throughout a 12-week course of rehabilitation for managing distal symmetric polyneuropathy. Outcome measures will be collected at standard intervals and compared with pre-treatment measures to evaluate effectiveness of treatment.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Polyneuropathies

• NCT number: NCT06452914
• Study type: Interventional
• Source: Endocrine Research Solutions
• Contact: Jessica Tapia
• Phone: 6788784750
• Email: Endoresearch@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Completion date: June 2025