RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-11

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06452914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Jessica Tapia

CONTACT

6788784750

Endoresearch@gmail.com

Korie Miles

CONTACT

6788784750

Endoresearch@gmail.com

Principal Investigator

Gina Myers

STUDY_DIRECTOR

INCREDIWEAR HOLDINGS, INC.

John Reed

PRINCIPAL_INVESTIGATOR

Endocrine Research Solutions. Inc.

Study Locations (Sites)

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076

United States

Collaborators and Investigators

Sponsor: Endocrine Research Solutions

Gina Myers, STUDY_DIRECTOR, INCREDIWEAR HOLDINGS, INC.
John Reed, PRINCIPAL_INVESTIGATOR, Endocrine Research Solutions. Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-11

Study Completion Date2025-06

Study Record Updates

Study Start Date2024-06-11

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Neuropathy