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

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.

Eligibility

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

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