Diabetic NeuropathyNCT06452914
Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks
A study testing Semiconductor Embedded Therapeutic Socks in people with Diabetic Neuropathy, run by Endocrine Research Solutions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Semiconductor Embedded Therapeutic Socks
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Jessica Tapia, 678-878-4750
About this study
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.
Read the 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.
- Conditions
- Diabetic Neuropathy
- Being tested
- Semiconductor Embedded Therapeutic Socks, Placebo Socks
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiconductor Embedded Therapeutic SocksDevice
Semiconductor Embedded Therapeutic Socks
Placebo SocksDevice
Socks not containing the Semiconductor Embedded Therapeutic fabric
| Study group | Role | What they receive |
|---|---|---|
| Semiconductor Embedded Therapeutic Socks | Experimental | Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks Receives: Device: Semiconductor Embedded Therapeutic Socks |
| Placebo Socks | Placebo comparator | Treatment of Distal Symmetric Polyneuropathy Using Placebo Socks as a Comparator to Semiconductor Embedded Therapeutic Socks Receives: Device: Placebo Socks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
LEFS consists of 20 items, each scored on a 5-point scale (0 = extreme difficulty, 4 = no difficulty).
Scoring: The maximum score is 80, with higher scores indicating better function. A lower score suggests greater disability or difficulty in performing daily activities.
The MNSI has two parts- Part A: Self-administered questionnaire with 15 items about symptoms related to neuropathy. Scoring is based on the presence or absence of symptoms, with a higher score indicating more symptoms.
Part B: Physical examination conducted by a healthcare professional that includes inspection of the feet and assessment of reflexes and sensation. A higher score indicates more severe neuropathy.
QOL-DN encompasses multiple domains such as physical health, emotional well-being, social participation, and specific neurological symptoms.
Scoring: Each domain is scored individually, and a composite score can be derived, from -4 to 136. Higher scores indicate better quality of life.
Measured: 12 Weeks
Secondary outcomes (4)
Reduction in pain as determined by pre-treatment and post-treatment Numeric Pain Rating Scale or Visual Analog Scale (VAS) compared to placebo.
Reduction in pain as measured by Visual Analog Scale from 1 to 10, with 1 being mild and 10 being severe.
Measured: 12 Weeks
Reduction in symptom severity upon physical examination and improvement in quantitative sensory testing measures from pre-treatment measures compared to placebo.
A series of tests are performed. Through the use of a tuning fork placed on the foot, if the patient no longer feels vibration after 8 seconds but does feel it for longer than 8 seconds when placed on the hand, severity of neuropathy can be determined. Through the use of a reflex hammer, tapping the ankle determines the presence or absence of ankle reflexes. Mono-filament testing, where after a series of touches in specific locations on the bottom of the foot, the presence or absence of sensation can be quantified.
Measured: 12 Weeks
Improvement in tissue oxygenation of the affected foot/feet as determined by clinically captured images with the non-invasive Kent Imaging device and pulse oximeter compared to placebo.
Improvement in tissue oxygenation of the affected foot/feet as determined by clinically captured images with the non-invasive Kent Imaging device and pulse oximeter compared to placebo.
Measured: 12 Weeks
Compliance with device usage throughout the study, reported weekly.
Device usage will be tracked with a device usage log that the patient completes based on hours the device is worn every day, to self-report compliance.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start11 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups; one group that will be assigned the treatment socks and the second group that will be assigned the placebo socks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endocrine Research Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Responsible party
- Principal investigator, John Chip H. Reed, Endocrine Research Solutions
- Investigators
- Gina Myers, Study director, INCREDIWEAR HOLDINGS, INC.John Reed, Principal investigator, Endocrine Research Solutions. Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452914
- Sponsor's protocol ID
- 2024-1
- Status last verified
- Feb 2025
- First submitted
- 30 May 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is undecided if individual participant data will be made available to other researchers during or after the course of the trial.
Publications
Roikjer J, Morch CD, Ejskjaer N. Diabetic Peripheral Neuropathy: Diagnosis and Treatment. Curr Drug Saf. 2021;16(1):2-16. doi: 10.2174/1574886315666200731173113.
PubMed 32735526Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.
PubMed 29709457Marino K, Lee R, Lee P. Effect of Germanium-Embedded Knee Sleeve on Osteoarthritis of the Knee. Orthop J Sports Med. 2019 Oct 25;7(10):2325967119879124. doi: 10.1177/2325967119879124. eCollection 2019 Oct.
PubMed 31696136Leung TK. In Vitro and In Vivo Studies of the Biological Effects of Bioceramic (a Material of Emitting High Performance Far-Infrared Ray) Irradiation. Chin J Physiol. 2015 Jun 30;58(3):147-55. doi: 10.4077/CJP.2015.BAD294.
PubMed 26014120Kyselovic J, Masarik J, Kechemir H, Koscova E, Turudic II, Hamblin MR. Physical properties and biological effects of ceramic materials emitting infrared radiation for pain, muscular activity, and musculoskeletal conditions. Photodermatol Photoimmunol Photomed. 2023 Jan;39(1):3-15. doi: 10.1111/phpp.12799. Epub 2022 May 21.
PubMed 35510621Cho SY, Roh YS, Roh HT. Evaluation of tympanic temperature and thermal sensation responses during exercise to verify the positive effects of wearing germanium-coated functional clothing. J Phys Ther Sci. 2016 Jun;28(6):1860-3. doi: 10.1589/jpts.28.1860. Epub 2016 Jun 28.
PubMed 27390434Siao P, Cros DP. Quantitative sensory testing. Phys Med Rehabil Clin N Am. 2003 May;14(2):261-86. doi: 10.1016/s1047-9651(02)00122-5.
PubMed 12795516Jia ZR, Wang TT, Wang HX. Significance of quantitative sensory testing in the diagnosis of diabetic peripheral neuropathy. J Clin Neurophysiol. 2014 Oct;31(5):437-40. doi: 10.1097/WNP.0000000000000086.
PubMed 25271682The Effect of Therapeutic Garments on Blood Flow as measured by a Laser Doppler Blood Flow Monitor; Michelle Lott, Raines DeMint. Lean RA QA Systems; May 13, 2017
Duranti C, Bagni G, Iorio J, Colasurdo R, Devescovi V, Arcangeli A. Effects of Germanium embedded fabric on the chondrogenic differentiation of adipose derived stem cells. Tissue Cell. 2024 Oct;90:102507. doi: 10.1016/j.tice.2024.102507. Epub 2024 Jul 30.
PubMed 39128191Justice TE, Jacob PB. Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study. J Orthop. 2023 Nov 24;49:102-106. doi: 10.1016/j.jor.2023.11.044. eCollection 2024 Mar.
PubMed 38094981Empowering Recovery: Surface Electromyography Shows how Incrediwear Helps Professional Athletes Recover. Incrediwear Holdings, Inc. Dec. 2021
Park JH, Lee S, Cho DH, Park YM, Kang DH, Jo I. Far-infrared radiation acutely increases nitric oxide production by increasing Ca(2+) mobilization and Ca(2+)/calmodulin-dependent protein kinase II-mediated phosphorylation of endothelial nitric oxide synthase at serine 1179. Biochem Biophys Res Commun. 2013 Jul 12;436(4):601-6. doi: 10.1016/j.bbrc.2013.06.003. Epub 2013 Jun 10.
PubMed 23756809Fateh HR, Madani SP, Heshmat R, Larijani B. Correlation of Michigan neuropathy screening instrument, United Kingdom screening test and electrodiagnosis for early detection of diabetic peripheral neuropathy. J Diabetes Metab Disord. 2016 Mar 25;15:8. doi: 10.1186/s40200-016-0229-7. eCollection 2015.
PubMed 27019831NIH Repository Diabetes in Youth. Michigan Neuropathy Screening Instrument, University of Michigan 2014. https://repository.niddk.nih.gov/media/studies/search/MOPs/SEARCH%201-3%20MOP/SEARCH(16).pdf. PDF download.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks
- ClinicalTrials.gov ID
- NCT06452914
- Acronym / sponsor ID
- 2024-1
- Conditions
- Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Endocrine Research SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups; one group that will be assigned the treatment socks and the second group that will be assigned the placebo socks.
| Arm | Type | Receives |
|---|---|---|
| Semiconductor Embedded Therapeutic Socks | Experimental | Device: Semiconductor Embedded Therapeutic SocksTreatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks |
| Placebo Socks | Placebo comparator | Device: Placebo SocksTreatment of Distal Symmetric Polyneuropathy Using Placebo Socks as a Comparator to Semiconductor Embedded Therapeutic Socks |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semiconductor Embedded Therapeutic SocksSemiconductor Embedded Therapeutic Socks | Device | Semiconductor Embedded Therapeutic Socks |
| Placebo SocksSocks not containing the Semiconductor Embedded Therapeutic fabric | Device | Placebo Socks |
Primary outcome
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
LEFS consists of 20 items, each scored on a 5-point scale (0 = extreme difficulty, 4 = no difficulty). Scoring: The maximum score is 80, with higher scores indicating better function. A lower score suggests greater disability or difficulty in performing daily activities. The MNSI has two parts- Part A: Self-administered questionnaire with 15 items about symptoms related to neuropathy. Scoring is based on the presence or absence of symptoms, with a higher score indicating more symptoms. Part B: Physical examination conducted by a healthcare professional that includes inspection of the feet and assessment of reflexes and sensation. A higher score indicates more severe neuropathy. QOL-DN encompasses multiple domains such as physical health, emotional well-being, social participation, and specific neurological symptoms. Scoring: Each domain is scored individually, and a composite score can be derived, from -4 to 136. Higher scores indicate better quality of life.
4 secondary outcomes
Reduction in pain as determined by pre-treatment and post-treatment Numeric Pain Rating Scale or Visual Analog Scale (VAS) compared to placebo.
Time frame: 12 Weeks
Reduction in symptom severity upon physical examination and improvement in quantitative sensory testing measures from pre-treatment measures compared to placebo.
Time frame: 12 Weeks
Improvement in tissue oxygenation of the affected foot/feet as determined by clinically captured images with the non-invasive Kent Imaging device and pulse oximeter compared to placebo.
Time frame: 12 Weeks
Compliance with device usage throughout the study, reported weekly.
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 32735526Roikjer J, Morch CD, Ejskjaer N. Diabetic Peripheral Neuropathy: Diagnosis and Treatment. Curr Drug Saf. 2021;16(1):2-16. doi: 10.2174/1574886315666200731173113.
- Background: PubMed 29709457Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.
- Background: PubMed 31696136Marino K, Lee R, Lee P. Effect of Germanium-Embedded Knee Sleeve on Osteoarthritis of the Knee. Orthop J Sports Med. 2019 Oct 25;7(10):2325967119879124. doi: 10.1177/2325967119879124. eCollection 2019 Oct.
- Background: PubMed 26014120Leung TK. In Vitro and In Vivo Studies of the Biological Effects of Bioceramic (a Material of Emitting High Performance Far-Infrared Ray) Irradiation. Chin J Physiol. 2015 Jun 30;58(3):147-55. doi: 10.4077/CJP.2015.BAD294.
- Background: PubMed 35510621Kyselovic J, Masarik J, Kechemir H, Koscova E, Turudic II, Hamblin MR. Physical properties and biological effects of ceramic materials emitting infrared radiation for pain, muscular activity, and musculoskeletal conditions. Photodermatol Photoimmunol Photomed. 2023 Jan;39(1):3-15. doi: 10.1111/phpp.12799. Epub 2022 May 21.
- Background: PubMed 27390434Cho SY, Roh YS, Roh HT. Evaluation of tympanic temperature and thermal sensation responses during exercise to verify the positive effects of wearing germanium-coated functional clothing. J Phys Ther Sci. 2016 Jun;28(6):1860-3. doi: 10.1589/jpts.28.1860. Epub 2016 Jun 28.
- Background: PubMed 12795516Siao P, Cros DP. Quantitative sensory testing. Phys Med Rehabil Clin N Am. 2003 May;14(2):261-86. doi: 10.1016/s1047-9651(02)00122-5.
- Background: PubMed 25271682Jia ZR, Wang TT, Wang HX. Significance of quantitative sensory testing in the diagnosis of diabetic peripheral neuropathy. J Clin Neurophysiol. 2014 Oct;31(5):437-40. doi: 10.1097/WNP.0000000000000086.
- BackgroundThe Effect of Therapeutic Garments on Blood Flow as measured by a Laser Doppler Blood Flow Monitor; Michelle Lott, Raines DeMint. Lean RA QA Systems; May 13, 2017
- Background: PubMed 39128191Duranti C, Bagni G, Iorio J, Colasurdo R, Devescovi V, Arcangeli A. Effects of Germanium embedded fabric on the chondrogenic differentiation of adipose derived stem cells. Tissue Cell. 2024 Oct;90:102507. doi: 10.1016/j.tice.2024.102507. Epub 2024 Jul 30.
- Background: PubMed 38094981Justice TE, Jacob PB. Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study. J Orthop. 2023 Nov 24;49:102-106. doi: 10.1016/j.jor.2023.11.044. eCollection 2024 Mar.
- BackgroundEmpowering Recovery: Surface Electromyography Shows how Incrediwear Helps Professional Athletes Recover. Incrediwear Holdings, Inc. Dec. 2021
- Individual participant dataSharing planned: Undecided. It is undecided if individual participant data will be made available to other researchers during or after the course of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gina Myers study director
INCREDIWEAR HOLDINGS, INC.
John Reed principal investigator
Endocrine Research Solutions. Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semiconductor Embedded Therapeutic Socks in people with Diabetic Neuropathy, run by Endocrine Research Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Tapia (6788784750, Endoresearch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06452914, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.