Recruiting

Therapeutic Socks

Sponsor:

Endocrine Research Solutions

Code:

NCT06452914

Conditions

Diabetic Neuropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Semiconductor Embedded Therapeutic Socks

Placebo Socks

Study Details

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

Study ID

NCT06452914

Start date

Jun 11, 2024

Status verified date

Feb, 2025

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semiconductor Embedded Therapeutic Socks

Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks

placebo comparator: Placebo Socks

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

Interventions

Semiconductor Embedded Therapeutic Socks

Semiconductor Embedded Therapeutic Socks

Placebo Socks

Socks not containing the Semiconductor Embedded Therapeutic fabric

Primary outcome measure

  • 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 [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Jessica Tapia

6788784750Endoresearch@gmail.com

Korie Miles

6788784750Endoresearch@gmail.com

Locations

Endocrine Research Solutions, Inc.

Recruiting

Roswell, Georgia, United States, 30076

Contacts

Jessica Tapia

678-878-4750

More Information

Sponsor

Endocrine Research Solutions

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Endocrine Research Solutions on 2025-02-25.