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

Key facts

Who runs it
Endocrine Research Solutions
Where
Roswell, United StatesSee the site
Trial code
Status
Recruiting
People taking part
80 people, planned
Started
11 Jun 2024
Planned end
Jun 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Semiconductor Embedded Therapeutic Socks
  • Placebo Socks
Record updated
25 February 2025

Who can take part

Age
18 years to 79 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patient has started a new medication for diabetic neuropathy symptoms within the past 90 days
  • 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 severe peripheral artery disease (with an ankle brachial index of <0.7)
  • Patient has chronic venous insufficiency (greater than stage 4)
  • 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
  • Patient is not within the ages of 18-79
  • 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 used tobacco within the last 90 days
  • Patient has an open wound at the area of application
  • Patient is unwilling or unable to sign the corresponding research subject consent form

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 79 years old?

Where in United States

  • Endocrine Research Solutions, IncRoswell, United StatesContact: Jessica TapiaTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Semiconductor Embedded Therapeutic SocksTreatment being tested

    Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks

  • Placebo SocksPlacebo, for comparison

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT06452914, who can take part
Record updated
25 February 2025