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

Trial Summary

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 data supports the effectiveness of the treatment Semiconductor Embedded Therapeutic Socks for diabetic neuropathy?

The study on smart socks using fiber-optics shows that similar technology can help manage risk factors like temperature and pressure in diabetic feet, which are important for preventing complications. ^{1 2 3 4 5}

Is there any safety data available for therapeutic socks used in diabetic neuropathy?

The studies reviewed did not report any specific safety concerns related to the use of therapeutic socks for diabetic neuropathy, suggesting they are generally safe for human use. ^{6 7 8 9 10}

How do Semiconductor Embedded Therapeutic Socks differ from other treatments for diabetic neuropathy?

Semiconductor Embedded Therapeutic Socks are unique because they likely incorporate flexible electronics to modulate nerve activity, which is different from traditional treatments that may focus on medication or physical therapy. This approach could offer a novel way to manage symptoms by directly interacting with nerve signals through advanced materials and technology. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Gina Myers

Principal Investigator

INCREDIWEAR HOLDINGS, INC.

John Reed

Principal Investigator

Endocrine Research Solutions. Inc.

Eligibility Criteria

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 sign the consent form for this study.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Optical-Fiber-Based Smart Textile (Smart Socks) to Manage Biomechanical Risk Factors Associated With Diabetic Foot Amputation. [2022]

2. Brazil 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. [2023]

3. United States 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. [2022]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

People with diabetic peripheral neuropathy display a decreased stepping accuracy during walking: potential implications for risk of tripping. [2017]

6. United States 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. [2019]

7. United States 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. [2008]

8. United States pubmed.ncbi.nlm.nih.gov

In-shoe multisensory data acquisition system. [2009]

9. Croatia pubmed.ncbi.nlm.nih.gov

Modified cotton socks--possibility to protect from diabetic foot infection. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Portable System for Monitoring the Microclimate in the Footwear-Foot Interface. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Selective fascicular stimulation of the rat sciatic nerve with multipolar polyimide cuff electrodes. [2006]

12. England pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

Decellular biological scaffold polymerized with PEDOT for improving peripheral nerve interface charge transfer. [2020]

14. Germany pubmed.ncbi.nlm.nih.gov

Stretchable, Fully Polymeric Electrode Arrays for Peripheral Nerve Stimulation. [2021]

15. England pubmed.ncbi.nlm.nih.gov

A microfabricated nerve-on-a-chip platform for rapid assessment of neural conduction in explanted peripheral nerve fibers. [2019]