Therapeutic Socks for Diabetic Neuropathy

Overseen By Korie Miles

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endocrine Research Solutions

Disqualifiers: Neurodegenerative conditions, Chronic pain, Auto-immune diseases, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with diabetic neuropathy, a nerve issue caused by diabetes that often affects the feet. It tests therapeutic socks embedded with special semiconductors, designed to manage symptoms such as pain, sensory loss, and the risk of foot ulcers. Participants will wear either these therapeutic socks or placebo socks for comparison over 12 weeks. Individuals diagnosed with mild to moderate diabetic neuropathy who experience symptoms like pain or numbness in their feet might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance symptom management for diabetic neuropathy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have started a new medication for diabetic neuropathy symptoms within the past 90 days, you may not be eligible to participate.

What prior data suggests that these therapeutic socks are safe for managing diabetic neuropathy?

Research has shown that therapeutic socks made with special materials are generally safe for users. Although detailed safety studies for these socks are not available, the trial is in the "Not Applicable" phase. This phase typically indicates that the treatment is not expected to cause harm and is primarily being tested for effectiveness.

These socks aim to alleviate diabetic neuropathy symptoms, such as numbness and pain in the feet, without compressing the legs. Because they do not squeeze, the risk of issues like reduced blood flow or discomfort is low. As with any new treatment, monitoring for changes or reactions while using them is important, but early findings suggest these socks are safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about semiconductor embedded therapeutic socks for diabetic neuropathy because they introduce a novel approach to managing nerve pain. Unlike traditional treatments like medications or topical creams, these socks are embedded with semiconductors that may help improve nerve function directly through non-invasive means. This innovative delivery method could offer a more convenient and potentially faster-acting relief compared to the standard care options, which often require ongoing medication with possible side effects. The unique mechanism harnesses the power of technology to provide targeted therapy, potentially offering a new avenue for managing diabetic neuropathy symptoms effectively.

What evidence suggests that these therapeutic socks are effective for diabetic neuropathy?

This trial will compare Semiconductor Embedded Therapeutic Socks with Placebo Socks for treating distal symmetric polyneuropathy. Research has shown that special therapeutic socks with embedded technology might help manage this common type of diabetic nerve damage. These socks boost blood flow in the feet, potentially reducing symptoms like pain and numbness. Unlike compression socks, they use body heat to activate the technology that enhances circulation. Although direct evidence on their effectiveness is still being gathered, their function suggests they could offer relief. Early studies indicate they might improve the quality of life for people with diabetic neuropathy. ^{1 2 3 4 5}

Who Is on the Research Team?

John Reed

Principal Investigator

Endocrine Research Solutions. Inc.

Gina Myers

Principal Investigator

INCREDIWEAR HOLDINGS, INC.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-79 with mild to moderate Diabetic Neuropathy, scoring between 2 and 7 on the MNSI. Participants must be experiencing symptoms of neuropathy, able to follow the study schedule and guidelines, and willing to sign a consent form.

Inclusion Criteria

I experience symptoms of nerve damage due to diabetes.

I am willing and able to follow the study's schedule and rules.

I am willing and able to sign the consent form for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semiconductor embedded therapeutic socks for managing distal symmetric polyneuropathy

12 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semiconductor Embedded Therapeutic Socks

Trial Overview The study tests therapeutic socks embedded with semiconductors against placebo socks over a 12-week period in managing diabetic neuropathy. Effectiveness will be measured by comparing outcomes at set intervals with pre-treatment status.

How Is the Trial Designed?

Group I: Semiconductor Embedded Therapeutic Socks Experimental Treatment 1 Intervention

Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks

Group II: Placebo Socks Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Endocrine Research Solutions

Lead Sponsor

Trials

1

Recruited

80+

INCREDIWEAR HOLDINGS, INC.

Industry Sponsor

Trials

6

Recruited

630+

Published Research Related to This Trial

The nerve-on-a-chip platform allows for rapid and precise recording of action potentials from multiple myelinated fibers, enhancing our ability to study peripheral nerve activity in a controlled environment.

This platform also enables selective neuro-inhibition through localized heat application, demonstrating its potential for optimizing implantable nerve interfaces and testing neuromodulation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A microfabricated nerve-on-a-chip platform for rapid assessment of neural conduction in explanted peripheral nerve fibers. Gribi, S., du Bois de Dunilac, S., Ghezzi, D., et al.[2019]

In a study involving 86 neuropathic diabetic patients, specially designed socks provided high patient satisfaction, with 85% rating them as good or very good, indicating their acceptability for pressure relief in high-risk diabetic feet.

The use of these socks, along with extra-depth shoes, resulted in the healing of 10 ulcers while only 7 new ulcers developed, suggesting they may effectively contribute to foot protection in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of experimental socks in the care of the high-risk diabetic foot. A multicenter patient evaluation study. American Group for the Study of Experimental Hosiery in the Diabetic Foot. Murray, HJ., Veves, A., Young, MJ., et al.[2019]

Modified cotton socks infused with natural minerals and active carbon were tested for their ability to protect against diabetic foot infections, which are a common and serious complication for diabetic patients.

The study assessed both in vitro and in vivo properties of the socks, including antimicrobial effectiveness against various pathogens and comfort for patients, while ensuring durability after 15 washes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified cotton socks--possibility to protect from diabetic foot infection. Tarbuk, A., Grancarić, AM., Magaš, S.[2018]

Pregabalin is strongly recommended as an effective treatment for painful diabetic neuropathy (PDN), based on a systematic review of literature from 1960 to 2008 involving various pharmacologic and nonpharmacologic therapies.

Other treatments like venlafaxine, duloxetine, and gabapentin are considered probably effective for PDN, but many have side effects that may limit their use, highlighting the need for more research on their impact on physical function and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Bril, V., England, J., Franklin, GM., et al.[2022]

Pregabalin is strongly recommended as an effective treatment for painful diabetic neuropathy (PDN), based on a systematic review of literature from 1960 to 2008 involving various pharmacological and non-pharmacological interventions.

Other treatments like venlafaxine, duloxetine, and gabapentin are considered probably effective, but many treatments have side effects that may limit their usefulness, highlighting the need for more research on their impact on physical function and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Bril, V., England, J., Franklin, GM., et al.[2022]

Patients with diabetic peripheral neuropathy (DPN) and those with diabetes but no neuropathy showed significantly less accuracy in stepping on targets compared to healthy controls, indicating impaired motor control in these groups.

Preliminary analysis of visual gaze behavior suggested that individuals with DPN were slower to shift their gaze between targets, which may contribute to their reduced stepping accuracy and ability to navigate obstacles while walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

People with diabetic peripheral neuropathy display a decreased stepping accuracy during walking: potential implications for risk of tripping. Handsaker, JC., Brown, SJ., Bowling, FL., et al.[2017]

The study demonstrated that a new flexible polyimide spiral-cuff electrode with integrated platinum contacts can selectively stimulate different nerve fascicles in the rat sciatic nerve, allowing for targeted motor responses.

Selective stimulation was effective even in the small sciatic nerve, with the ability to control muscle activation (dorsiflexion vs. plantarflexion) based on the stimulation intensity and configuration, indicating potential for precise nerve control in future applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective fascicular stimulation of the rat sciatic nerve with multipolar polyimide cuff electrodes. Navarro, X., Valderrama, E., Stieglitz, T., et al.[2006]

In a study involving 30 neuropathic diabetic patients, socks containing nanocapsules with a hydrating agent significantly improved skin hydration and other parameters after 6 weeks compared to regular socks without nanocapsules.

The treatment was found to be safe, with no adverse events reported, highlighting the potential of nanocapsule technology for enhancing foot care in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of nanotechnology-designed footsock in the management of preulcerative conditions in the diabetic foot: results of a single, blind randomized study. Banchellini, E., Macchiarini, S., Dini, V., et al.[2008]

Peripheral nerve interfaces are crucial for bioelectronic medicine, allowing for the recording and modulation of nerve activity in visceral organs, with various devices already implanted in humans.

There is a need for improved performance of these devices, including better biocompatibility, chronic reliability, and enhanced signal quality, which can be achieved through new materials and innovative microfabrication techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in materials and flexible electronics for peripheral nerve interfaces. Bettinger, CJ.[2020]

Regenerative peripheral nerve interfaces (RPNIs) can effectively transfer nerve signals to control motorized prosthetics, and using poly3,4-ethylenedioxythiophene (PEDOT) to coat the interface material significantly improves the efficiency of this signal transfer.

The study demonstrated that PEDOT-coated materials distribute electrical stimulation more effectively than uncoated materials, allowing for better ionic signal distribution within the RPNI while reducing the charge density needed for effective stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decellular biological scaffold polymerized with PEDOT for improving peripheral nerve interface charge transfer. Frost, CM., Cederna, PS., Martin, DC., et al.[2020]

Conductive elastomers (CEs) used in nerve cuff devices show improved charge transfer properties and mechanical stability compared to traditional metallic electrodes, making them a promising alternative for bioelectronic applications.

The CE cuffs demonstrated superior performance in an ex vivo whole sciatic nerve model, indicating their potential for safe and effective use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stretchable, Fully Polymeric Electrode Arrays for Peripheral Nerve Stimulation. Cuttaz, EA., Chapman, CAR., Syed, O., et al.[2021]

An innovative electronic system embedded in shoes can effectively monitor temperature, pressure, and humidity for patients with diabetes and peripheral neuropathy, helping to prevent unnoticed foot injuries.

The system's pressure sensors showed strong correlation with known values (r > 0.85), indicating reliable data collection that could eventually be used to provide real-time feedback to patients about their foot health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-shoe multisensory data acquisition system. Morley, RE., Richter, EJ., Klaesner, JW., et al.[2009]

A new portable device that continuously monitors the diabetic foot can significantly reduce complications by tracking micro-climate conditions like temperature and humidity between the insole and sole of footwear.

The device uses ten sensors to collect precise data, which can help footwear manufacturers create better diabetic shoes that minimize the risk of dry skin and foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable System for Monitoring the Microclimate in the Footwear-Foot Interface. Sandoval-Palomares, Jde J., Yáñez-Mendiola, J., Gómez-Espinosa, A., et al.[2018]

A 12-week group-based foot-ankle exercise program for individuals with diabetic neuropathy led to significant improvements in hip extensor moments at push-off and increased hallux contact area, indicating better propulsion during walking.

While the exercise program showed some positive effects on specific aspects of foot-ankle function, it did not significantly change overall lower limb biomechanics or plantar pressure in other areas, suggesting that more intensive or individualized interventions may be necessary for broader improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of foot-ankle exercises on foot-ankle kinematics, plantar pressure, and gait kinetics in people with diabetic neuropathy: Secondary outcomes from a randomized controlled trial. Monteiro, RL., Ferreira, JSSP., Silva, ÉQ., et al.[2023]

The study validated a smart textile, SmartSox, that uses fiber optics to simultaneously measure plantar temperature, pressure, and joint angles in patients with diabetic peripheral neuropathy (DPN), showing excellent agreement with established measurement methods.

The results indicate that SmartSox can effectively assess foot risk factors for ulcers in DPN patients, potentially allowing for better clinical decision-making and timely interventions to prevent serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Optical-Fiber-Based Smart Textile (Smart Socks) to Manage Biomechanical Risk Factors Associated With Diabetic Foot Amputation. Najafi, B., Mohseni, H., Grewal, GS., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06452914/clinical-outcomes-related-to-treatment-of-distal-symmetric-polyneuropathy-using-semiconductor-embedded-therapeutic-socks

Clinical Outcomes Related to Treatment of Distal ... The proposed study seeks to evaluate the effectiveness of a non-compressive therapeutic socks throughout a 12-week course of rehabilitation for managing distal ...

2. withpower.com withpower.com/trial/phase-diabetic-neuropathies-5-2024-50ac8

Therapeutic Socks for Diabetic Neuropathy Trial Overview The study tests therapeutic socks embedded with semiconductors against placebo socks over a 12-week period in managing diabetic neuropathy.

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/253/diabetic-neuropathy

Diabetic Neuropathy Clinical Research Trials Unlike compression products, the semiconductor embedded socks increase blood circulation through activation of the elements with heat of the body, and releases ...

4. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=3374042

Endocrine Research Solutions Trials NCT06452914: Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks. Recruiting. N/A. 80. US.

5. drugtrialsformoney.com drugtrialsformoney.com/clinical-outcomes-related-to-treatment-of-distal-symmetric-polyneuropathy-using-semiconductor-embedded-therapeutic-socks/

Clinical Outcomes Related to Treatment of Distal Symmetric ... Clinical Outcomes Related to Treatment of Distal Symmetric Polyneuropathy Using Semiconductor Embedded Therapeutic Socks ... Conditions: Diabetic ...