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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Endocrine Research Solutions, Inc.
RECRUITING
Roswell
Contact Information
Primary
Jessica Tapia
Endoresearch@gmail.com
6788784750
Backup
Korie Miles
Endoresearch@gmail.com
6788784750
Time Frame
Start Date: 2024-06-11
Estimated Completion Date: 2025-06
Participants
Target number of participants: 80
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Endocrine Research Solutions
Collaborators: INCREDIWEAR HOLDINGS, INC.

This content was sourced from clinicaltrials.gov