Actively Recruiting

Phase Not Applicable
Age: 18Years - 79Years
All Genders
ID06452914

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

Led by Endocrine Research Solutions · Updated on 2025-02-25

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

E

Endocrine Research Solutions

Lead Sponsor

I

INCREDIWEAR HOLDINGS, INC.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Distal symmetric polyneuropathy, also called diabetic neuropathy, is a common nerve complication of diabetes that affects the longest nerve fibers, especially in the toes and feet. It causes sensory loss, pain, and increases the risk of foot ulcers and amputations, which lowers quality of life. This condition is usually not reversible, and current management focuses on slowing its progression and preventing complications. The study aims to evaluate the use of semiconductor embedded therapeutic socks in managing this condition over a 12-week rehabilitation period. The study compares the effects of semiconductor embedded therapeutic socks, which emit mid and far infrared waves and negative ions to improve blood flow and reduce inflammation, against placebo socks that do not contain this fabric. Participants will wear these socks during the 12-week treatment phase. The socks’ technology is believed to activate biological pathways that reduce pain and inflammation locally, unlike systemic treatments. The study will collect outcome measures at standard intervals to assess the socks’ impact on diabetic neuropathy symptoms and function. Participants will be assessed before and after treatment using specific questionnaires and physical exams to measure function, pain, symptom severity, and foot tissue oxygenation. Compliance with sock use will be monitored weekly. The primary outcome is improved patient function measured by standardized scales over 12 weeks. Secondary outcomes include pain reduction, symptom improvement, and better blood oxygen levels in the feet. The study is randomized, double-blind, and will last at least 12 weeks for each participant.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with mild to moderate Diabetic Neuropathy with a score between 2 and 7 out of 10 on the Michigan Neuropathy Screening Instrument (MNSI) upon clinical examination
  • Patients reporting symptoms of Diabetic Neuropathy
  • Patients aged 18 to 79 years
  • Patients willing and able to follow the study schedule and guidelines
  • Patients willing and able to sign the research consent form
Not Eligible

You will not qualify if you...

  • History of neurodegenerative diseases such as multiple sclerosis or Parkinson's disease
  • Chronic pain conditions unrelated to diabetic neuropathy, including spinal stenosis, low back pain, or sciatica
  • Autoimmune or autoinflammatory diseases other than diabetic neuropathy, including Multiple Sclerosis or Lyme Disease
  • History of stroke
  • Any type of paralysis
  • MNSI score less than 2 or greater than 7 out of 10
  • Severe peripheral artery disease (ankle brachial index less than 0.7)
  • Chronic venous insufficiency greater than stage 4
  • Tobacco use within the last 90 days
  • Open wound at the sock application area
  • Started new medication for diabetic neuropathy symptoms within the past 90 days
  • Outside the age range of 18 to 79 years
  • Unwilling or unable to sign the research consent form
  • Any other condition that might prevent study completion or affect results as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants wear semiconductor embedded therapeutic socks or placebo socks to manage symptoms of diabetic neuropathy and improve blood circulation and pain relief.

Weekly visits for up to 12 weeks

Trial Site Locations

Total: 1 location

1

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States, 30076

Actively Recruiting

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Research Team

J

Jessica Tapia

K

Korie Miles

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Physical properties and biological effects of ceramic materials emitting infrared radiation for pain, muscular activity, and musculoskeletal conditions.

Jan Kyselovic, Jozef Masarik, Hayet Kechemir...

https://pubmed.ncbi.nlm.nih.gov/35510621

Evaluation of tympanic temperature and thermal sensation responses during exercise to verify the positive effects of wearing germanium-coated functional clothing.

Su Youn Cho, Youn Sun Roh, Hee Tae Roh

https://pubmed.ncbi.nlm.nih.gov/27390434