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

Part of paid clinical trials in Roswell, Georgia.

Sponsor
Endocrine Research Solutions
Study ID
NCT06452914
Status
Recruiting
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Conditions

  • Diabetic Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Semiconductor Embedded Therapeutic Socks — DEVICE
    Semiconductor Embedded Therapeutic Socks
  • Placebo Socks — DEVICE
    Socks not containing the Semiconductor Embedded Therapeutic fabric

Study Details

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.

Key Dates

Start date
Jun 11, 2024
Status verified
Feb 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Improved patient function as determined by pre-treatment and post-treatment Patient Specific Lower Extremity Functional Scale (LEFS), Michigan Neuropathy Screening Instrument (MNSI), and Quality of Life Questionnaire-Diabetic Neuropathy (QOL-DN) compared [ Time Frame: 12 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Endocrine Research Solutions, Inc.RoswellGeorgia30076
Jessica Tapia
678-878-4750

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Endocrine Research Solutions, Inc.· Roswell, GA

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