Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452914
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-30
Brief Title:
Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks
Sponsor:
Endocrine Research Solutions
Organization:
Endocrine Research Solutions
Study Overview
Official Title:
Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Treatments for diabetic neuropathy includes a systematic stepwise approach that entails glycemic control and control of metabolic syndrome symptomatic treatment of pain and counseling on foot care and safety measures
Unlike compression products the semiconductor embedded socks increase blood circulation through activation of the elements with heat of the body and releases mid and far infrared waves as well as negative ions Both infrared waves and negative ions are biologically active and mediate inflammatory and pain pathways in the body The technology has also been shown to increase blood speed and blood flow The technology has also been shown to
Increase blood flow and velocity
Reduce osteoarthritis pain
Reduce effusion post total knee arthroplasty
Improve chondrogenic differentiation in vitro
Improve muscle recovery
Increase circulation by up to 22 at rest
Improve functional outcomes
The benefits of the Infrared Wave and Negative Ion therapy include
Inhibition of Cox-2 and Prostaglandins in the lipopolysaccharide LPS-moderated pain pathway
Up-regulation of heat shock protein
Mediated Nitric oxide production
Increased activity of voltage-gated ion channels
Increased activity of mechanosensitive ion channels
Polarization of cell surface membranes
Protecting muscle damage
Scavenging of Reactive Oxygen Species ROS
Improved thermoregulation
To date studies have shown that the semiconductor embedded fabric increase circulation by up to 22 at rest and have shown powerful results in reducing inflammation swelling improving range of motion in the knee post-surgery and providing pain relief
The semiconductor embedded fabric emits mid-level and far infrared waves and negative ions Delivery of infrared waves and negative ions to the tissue increases blood flow facilitates the anti-inflammatory nitric oxide NO cascade by accelerating the binding of calcium Ca2 to calmodulin CaM NO provides several healing factors to the body as a vasodilator increasing blood and lymphatic flow Additionally NO down-regulates interleukin-1 beta IL1β and inducible nitric oxide synthase iNOS in certain cell types which leads to reduced cyclooxygenase-2 COX-2 and prostaglandins - molecules responsible for causing inflammation and pain Unlike other systemic COX-2 inhibitors such as nonsteroidal anti-inflammatory drugs NSAIDs targeted infrared and negative ion therapy stimulate localized reaction pathways thereby reducing pain and inflammation
This study seeks to identify patient reported outcomes for management of Diabetic Neuropathy with semiconductor embedded fabric in the affected area
Unlike compression products the semiconductor embedded socks increase blood circulation through activation of the elements with heat of the body and releases mid and far infrared waves as well as negative ions Both infrared waves and negative ions are biologically active and mediate inflammatory and pain pathways in the body The technology has also been shown to increase blood speed and blood flow The technology has also been shown to
Increase blood flow and velocity
Reduce osteoarthritis pain
Reduce effusion post total knee arthroplasty
Improve chondrogenic differentiation in vitro
Improve muscle recovery
Increase circulation by up to 22 at rest
Improve functional outcomes
The benefits of the Infrared Wave and Negative Ion therapy include
Inhibition of Cox-2 and Prostaglandins in the lipopolysaccharide LPS-moderated pain pathway
Up-regulation of heat shock protein
Mediated Nitric oxide production
Increased activity of voltage-gated ion channels
Increased activity of mechanosensitive ion channels
Polarization of cell surface membranes
Protecting muscle damage
Scavenging of Reactive Oxygen Species ROS
Improved thermoregulation
To date studies have shown that the semiconductor embedded fabric increase circulation by up to 22 at rest and have shown powerful results in reducing inflammation swelling improving range of motion in the knee post-surgery and providing pain relief
The semiconductor embedded fabric emits mid-level and far infrared waves and negative ions Delivery of infrared waves and negative ions to the tissue increases blood flow facilitates the anti-inflammatory nitric oxide NO cascade by accelerating the binding of calcium Ca2 to calmodulin CaM NO provides several healing factors to the body as a vasodilator increasing blood and lymphatic flow Additionally NO down-regulates interleukin-1 beta IL1β and inducible nitric oxide synthase iNOS in certain cell types which leads to reduced cyclooxygenase-2 COX-2 and prostaglandins - molecules responsible for causing inflammation and pain Unlike other systemic COX-2 inhibitors such as nonsteroidal anti-inflammatory drugs NSAIDs targeted infrared and negative ion therapy stimulate localized reaction pathways thereby reducing pain and inflammation
This study seeks to identify patient reported outcomes for management of Diabetic Neuropathy with semiconductor embedded fabric in the affected area
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None