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New treatment option for Diabetic Neuropathy
Official title Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks
ClinicalTrials.gov ID: NCT06452914
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Roswell, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roswell, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.