RecruitingNot ApplicableNCT06452914

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


Sponsor

Endocrine Research Solutions

Enrollment

80 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Placebo Socks and a medical device called Semiconductor Embedded Therapeutic Socks for people with diabetic neuropathy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESemiconductor Embedded Therapeutic Socks

Semiconductor Embedded Therapeutic Socks

DEVICEPlacebo Socks

Socks not containing the Semiconductor Embedded Therapeutic fabric


Locations(1)

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States

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NCT06452914


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