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.
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
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
Parallel
Semiconductor Embedded Therapeutic Socks
DeviceSemiconductor Embedded Therapeutic Socks
Placebo Socks
DeviceSocks not containing the Semiconductor Embedded Therapeutic fabric
Improved patient function as determined by pre-treatment and post-treatment Patient Specific Lower Extremity Functional Scale (LEFS), Michigan Neuropathy Screening Instrument (MNSI), and Quality of Life Questionnaire-Diabetic Neuropathy (QOL-DN) compared
LEFS consists of 20 items, each scored on a 5-point scale (0 = extreme difficulty, 4 = no difficulty). Scoring: The maximum score is 80, with higher scores indicating better function. A lower score suggests greater disability or difficulty in performing daily activities. The MNSI has two parts- Part A: Self-administered questionnaire with 15 items about symptoms related to neuropathy. Scoring is based on the presence or absence of symptoms, with a higher score indicating more symptoms. Part B: Physical examination conducted by a healthcare professional that includes inspection of the feet and assessment of reflexes and sensation. A higher score indicates more severe neuropathy. QOL-DN encompasses multiple domains such as physical health, emotional well-being, social participation, and specific neurological symptoms. Scoring: Each domain is scored individually, and a composite score can be derived, from -4 to 136. Higher scores indicate better quality of life.
Reduction in pain as determined by pre-treatment and post-treatment Numeric Pain Rating Scale or Visual Analog Scale (VAS) compared to placebo.
Reduction in pain as measured by Visual Analog Scale from 1 to 10, with 1 being mild and 10 being severe.
Reduction in symptom severity upon physical examination and improvement in quantitative sensory testing measures from pre-treatment measures compared to placebo.
A series of tests are performed. Through the use of a tuning fork placed on the foot, if the patient no longer feels vibration after 8 seconds but does feel it for longer than 8 seconds when placed on the hand, severity of neuropathy can be determined. Through the use of a reflex hammer, tapping the ankle determines the presence or absence of ankle reflexes. Mono-filament testing, where after a series of touches in specific locations on the bottom of the foot, the presence or absence of sensation can be quantified.
Improvement in tissue oxygenation of the affected foot/feet as determined by clinically captured images with the non-invasive Kent Imaging device and pulse oximeter compared to placebo.
Improvement in tissue oxygenation of the affected foot/feet as determined by clinically captured images with the non-invasive Kent Imaging device and pulse oximeter compared to placebo.
Compliance with device usage throughout the study, reported weekly.
Device usage will be tracked with a device usage log that the patient completes based on hours the device is worn every day, to self-report compliance.
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Endocrine Research Solutions
Lead sponsor
INCREDIWEAR HOLDINGS, INC.
Collaborator
