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

NCT06452914 | Recruiting

• 1 other identifier: 2024-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Weeks

Secondary Outcomes (4)

• 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

• Reduction in symptom severity upon physical examination and improvement in quantitative sensory testing measures from pre-treatment measures 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

• Compliance with device usage throughout the study, reported weekly.

  12 Weeks

Study Arms (2)

Semiconductor Embedded Therapeutic Socks

EXPERIMENTAL

Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks

Device: Semiconductor Embedded Therapeutic Socks

Placebo Socks

PLACEBO COMPARATOR

Treatment of Distal Symmetric Polyneuropathy Using Placebo Socks as a Comparator to Semiconductor Embedded Therapeutic Socks

Device: Placebo Socks

Interventions

Semiconductor Embedded Therapeutic Socks DEVICE

Semiconductor Embedded Therapeutic Socks

Semiconductor Embedded Therapeutic Socks

Placebo Socks DEVICE

Socks not containing the Semiconductor Embedded Therapeutic fabric

Placebo Socks

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endocrine Research Solutions: lead
• INCREDIWEAR HOLDINGS, INC.: collaborator

Study Sites (1)

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

RECRUITING

Related Publications (22)

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  BACKGROUND

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• Michael G. Sowa,

  BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Gina Myers

  INCREDIWEAR HOLDINGS, INC.

  STUDY DIRECTOR

• John Reed

  Endocrine Research Solutions. Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Tapia

CONTACT

6788784750; Endoresearch@gmail.com

Korie Miles

CONTACT

6788784750; Endoresearch@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study is double blinded. Neither the Investigator or the subject will know which arm they have been assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to one of two groups; one group that will be assigned the treatment socks and the second group that will be assigned the placebo socks.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 11, 2024
• Study Start: June 11, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

US (1)