Actively Recruiting
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
50 weeks
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 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
Official Title
Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks
Who Can Participate
Eligibility Criteria
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 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
You will not qualify if you...
- History of neurodegenerative conditions such as multiple sclerosis or Parkinson's disease
- Presence of chronic pain conditions unrelated to diabetic neuropathy, including spinal stenosis, low back pain, and sciatica
- Auto-immune or auto-inflammatory 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 <0.7)
- Chronic venous insufficiency greater than stage 4
- Tobacco use within the last 90 days
- Open wound at the area of application
- Started new medication for diabetic neuropathy symptoms within the past 90 days
- Not aged between 18 and 79
- Unwilling or unable to sign the research consent form
- Any other condition or criteria that may prevent study completion or affect results as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States, 30076
Actively Recruiting
Research Team
J
Jessica Tapia
CONTACT
K
Korie Miles
CONTACT
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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