Back to search results

Study of Semiconductor Embedded Therapeutic Socks for Diabetic Neuropathy

This study is investigating whether special socks, called Semiconductor Embedded Therapeutic Socks, can help people with diabetic neuropathy (nerve damage caused by diabetes). Diabetic neuropathy can cause pain and loss of feeling, especially in the feet. The study will compare these special socks to regular placebo socks (socks without the special fabric). Researchers want to see if the Semiconductor Embedded Therapeutic Socks can improve your daily function, nerve health (measured by the Michigan Neuropathy Screening Instrument), and overall quality of life after 12 weeks. You may be able to join if you are between 18 and 79 years old and have been diagnosed with mild to moderate diabetic neuropathy with symptoms.

Study design
This interventional study plans to enroll 80 participants. It compares Semiconductor Embedded Therapeutic Socks to placebo socks.
What's involved
Participants will be assessed at the beginning and again after 12 weeks. You will need to adhere to the follow-up schedule and study guidelines.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after treatment to assess changes in function, neuropathy, and quality of life.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06452914

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

Recruiting
NAAges 18–79InterventionalTreatment
Endocrine Research Solutions
~80 participants
Updated 2025-02-25 on ClinicalTrials.gov
What's tested:Semiconductor Embedded Therapeutic SocksPlacebo Socks

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 12 Weeks

Conditions

Diabetic Neuropathy

Explore related trials

Diabetic Neuropathy

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Gina Myers · STUDY_DIRECTOR · INCREDIWEAR HOLDINGS, INC.
  • John Reed · PRINCIPAL_INVESTIGATOR · Endocrine Research Solutions. Inc.

Who to contact

Jessica Tapia
[email protected]
6788784750
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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) compared12 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.