Treatment of diabetic neuropathy using special therapeutic socks
Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks
This study is testing special therapeutic socks that might help people with diabetic neuropathy feel better by improving blood flow.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Endocrine Research Solutions Industry-sponsored |
| Locations | 1 site (Roswell, Georgia) |
| Trial ID | NCT06452914 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of semiconductor embedded therapeutic socks in treating distal symmetric polyneuropathy, commonly known as diabetic neuropathy. The socks are designed to enhance blood circulation through the release of mid and far infrared waves and negative ions, which may alleviate symptoms and improve quality of life for patients. Participants will be assessed based on their diabetic neuropathy symptoms and will either receive the therapeutic socks or a placebo. The study aims to provide a novel approach to managing this prevalent condition, which currently has limited treatment options.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-79 diagnosed with mild to moderate diabetic neuropathy.
Not a fit: Patients with neurodegenerative conditions or chronic pain unrelated to diabetic neuropathy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from diabetic neuropathy by alleviating symptoms and preventing complications.
How similar studies have performed: While the use of semiconductor technology in therapeutic applications is promising, this specific approach has not been widely tested in clinical settings for diabetic neuropathy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roswell, Georgia
- Endocrine Research Solutions, Inc. — Roswell, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: John Reed — Endocrine Research Solutions. Inc.
- Study coordinator: Jessica Tapia
- Email: Endoresearch@gmail.com
- Phone: 6788784750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.