Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This study is double blinded. Neither the Investigator or the subject will know which arm they have been assigned to.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 12 Weeks
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.
次要结局
- Compliance with device usage throughout the study, reported weekly.(12 Weeks)
- Reduction in symptom severity upon physical examination and improvement in quantitative sensory testing measures from pre-treatment measures compared to placebo.(12 Weeks)
- Reduction in pain as determined by pre-treatment and post-treatment Numeric Pain Rating Scale or Visual Analog Scale (VAS) compared to placebo.(12 Weeks)
- 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.(12 Weeks)
研究者
John Chip H. Reed
Principal Investigator
Endocrine Research Solutions