Digital Prosthetics + Exercise for Diabetic Amputation

Overseen By Paolo Bonato, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Spaulding Rehabilitation Hospital

Disqualifiers: Bilateral amputation, Unstable contralateral limb, Severe limb pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 months

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital prosthetic technology, Digital Prosthetic Interface Technology, combined with an exercise program to assist individuals who have lost a lower leg due to complications from type 2 diabetes. It tests whether this technology can enhance participants' health and mobility compared to traditional prosthetics. Participants will either use the new digital prosthetic or continue with their usual prosthetic setup. The trial seeks individuals with a single lower-leg amputation from diabetes, who have used a prosthesis for at least two months and own a smartphone. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative healthcare solutions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital prosthetic interface technology is safe for dysvascular amputees?

Research shows that digital prosthetic technology is improving, with safety as a key focus. Studies carefully monitor issues like losing balance or getting injured during testing. This ensures that any risks associated with the digital prosthetic are taken seriously and actively managed.

Since this trial is in an early stage, the researchers are still assessing the treatment's safety. Early trials often aim to evaluate how well people can use the new technology. Although specific safety data is not yet available, ensuring the safety of these devices remains a top priority in ongoing research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the digital prosthetic interface technology for diabetic amputation because it offers a cutting-edge alternative to the traditional socket and liner systems. This new technology from Bionic Skins promises a more personalized and comfortable fit by digitally interfacing with the user's residual limb, potentially enhancing mobility and reducing discomfort. Unlike conventional methods that often require manual adjustments and may lead to skin issues, the digital approach allows for real-time adjustments and improved skin health. This innovation could significantly improve the quality of life for individuals with diabetes who have undergone amputation.

What evidence suggests that this digital prosthetic interface technology is effective for dysvascular amputees?

This trial will compare the effectiveness of digital prosthetic interface technology with traditional socket and liner technology. Research has shown that new digital technology, which participants in this trial may receive, can improve control over prosthetic limbs. This technology enables users to perform multiple actions simultaneously, simplifying the use of the prosthetic limb. Early signs suggest that it could aid individuals who have lost a limb due to diabetes in moving more easily and feeling more comfortable. It combines modern technology with exercises to enhance overall health and limb function for those with circulation-related amputations. Although still under evaluation, the potential benefits for improving quality of life appear promising. ^{1 3 5 6 7}

Who Is on the Research Team?

Paolo Bonato, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with a lower limb amputation due to type 2 diabetes complications, who currently use a prosthesis and own a smartphone. They should be able to move at certain levels (K2 or K3) and have had their amputation within the last 4-16 months. People with bilateral amputations, unstable other limbs, conditions preventing exercise, current pregnancy, incompatible body measurements for technology use, or severe limb pain are excluded.

Inclusion Criteria

Own a smartphone

I had one lower leg amputated between 4 and 16 months ago.

My condition is due to complications from Type 2 Diabetes.

Exclusion Criteria

I have had both of my limbs amputated.

Current pregnancy

Your residuum (the remaining part of the limb after amputation) is too big for the equipment used to make the prosthetic socket.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements including SEQ, PEQ, and thermal imaging of the residuum are conducted

1 week

1 visit (in-person)

Treatment

Participants are randomized to either digital prosthetic interface technology or traditional socket-liner technology, combined with an exercise intervention

12 months

Monthly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on step counts and intra-socket interface pressure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Prosthetic Interface Technology

Trial Overview The study examines new socket and liner technology in digital prosthetic interfaces combined with an exercise program aimed at improving health in people who've lost a lower limb from diabetes-related issues. Participants will try out this tech-and-exercise combo to see how well it works.

How Is the Trial Designed?

Group I: digital prosthetic interface technology group Experimental Treatment 1 Intervention

Study participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins.

Group II: traditional socket and liner technology group Active Control 1 Intervention

Study participants randomized to this group will use a traditional socket-liner technology (i.e., study participants will use their own liner and socket system).

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Bionic Skins LLC

Collaborator

Trials

1

Recruited

40+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The DARPA Revolutionizing Prosthetics 2009 program developed a Virtual Integration Environment (VIE) that allows researchers and clinicians to collaboratively design and test prosthetic limbs, enhancing the integration of these devices with patient needs.

The VIE is being used by the Walter Reed Military Amputee Research Program to study and potentially reduce phantom limb pain in upper extremity amputees by modeling daily activities and capturing real-time muscle activity from the residual limb.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a virtual integration environment in treating phantom limb pain. Zeher, MJ., Armiger, RS., Burck, JM., et al.[2011]

Current prostheses for individuals with upper limb amputation or congenital limb difference are inadequate, leading to issues like rejection and pain, highlighting the need for improved solutions.

Emerging technologies such as robotic limbs and osseointegrated prostheses show promise in meeting user needs, but they also introduce new risks that must be carefully evaluated through user perspectives and feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper extremity prosthesis user perspectives on unmet needs and innovative technology. Benz, HL., Jia Yao, ., Rose, L., et al.[2022]

A new digital Patient Decision Aid (PDA-TULA) was developed to help adults with major unilateral upper limb absence make informed choices about terminal devices (TDs) for prosthesis selection, based on a systematic co-creation process involving patients, clinicians, and experts.

The PDA-TULA includes comprehensive information about TDs, allows users to reflect on their personal values, and facilitates comparison of TD options tailored to individual preferences, potentially improving decision-making and reducing rejection rates of prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The systematic and participatory development of a patient decision aid about terminal devices for people with upper limb absence: The PDA-TULA. Kerver, N., Boerema, L., Brouwers, MAH., et al.[2023]

The DEKA Arm, an advanced upper limb prosthesis, can be effectively controlled using foot controls, which were positively received by most of the 36 amputee subjects in the study.

With training, users were able to develop the necessary skills to operate the foot controls, indicating that this method can enhance the functionality of multifunction prostheses despite initial challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling a multi-degree of freedom upper limb prosthesis using foot controls: user experience. Resnik, L., Klinger, SL., Etter, K., et al.[2014]

The pressure casting technique (PCAST) for creating transtibial prosthetic sockets was successfully used on 13 adult volunteers, with a 62% success rate in fitting the prosthesis, indicating its potential for use in developing countries with limited resources.

Participants who used the prosthesis for an average of 167 days reported high satisfaction levels and showed significant improvements in physical function, such as faster timed up-and-go and longer six-minute walk distances, suggesting that PCAST can enhance mobility for individuals with unilateral amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure casting technique for transtibial prosthetic socket fit in developing countries. Lee, PV., Lythgo, N., Laing, S., et al.[2022]

The proposed prosthesis control technique utilizes a stocking with multiple sensors on the foot and leg to provide input for controlling an upper extremity prosthetic, allowing for more natural and simultaneous joint movements.

This innovative approach addresses the limitations of current commercial prosthetics, which typically operate joints in a serial manner, making them less intuitive and more difficult to use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling an artificial arm with foot movements. Luzzio, CC.[2022]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

The DARPA RE-NET Program aims to enhance neuroprosthesis technology for amputees by developing reliable neural interfaces that can effectively control robotic prostheses throughout the user's lifetime.

The program focuses on three key areas: ensuring long-term stability of neural interfaces, creating reliable connections to peripheral nerves, and improving central nervous system interfaces, all crucial for effective prosthetic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural interfaces for upper-limb prosthesis control: opportunities to improve long-term reliability. Judy, JW.[2016]

A structured protocol for testing lower limb prostheses emphasizes safety, requiring users to meet specific graded safety levels before progressing to more challenging environments.

This approach aims to reduce the risk of falls and injuries, thereby enhancing user confidence and overall experience with active prosthetic legs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation. Thesleff, A., Ahkami, B., Anderson, J., et al.[2022]

New prosthetic designs and advanced rehabilitation programs are now tailored to meet the fitness and performance needs of active amputees, allowing them to engage in a variety of sports and activities.

Collaboration among surgeons, prosthetists, and trainers has significantly improved the functionality of prostheses, enabling amputees to compete successfully in sports, highlighting a shift in focus from merely adapting to thriving with prosthetic technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in recreational prostheses and adaptive devices for the amputee. Michael, JW., Gailey, RS., Bowker, JH.[2022]

The rate of lower limb amputation in diabetic patients is decreasing, but it remains a significant complication, highlighting the ongoing need for effective prosthetic solutions.

Recent advancements in prosthetic technology and design have improved the mechanics of ambulation for below knee, ankle, and foot amputees, enhancing their mobility and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prosthetic options available for the diabetic lower limb amputee. Chitragari, G., Mahler, DB., Sumpio, BJ., et al.[2022]

A Prosthetic Interventions Core Outcome Set (PI-COS) was developed through a Delphi survey involving 65 prosthesis users and 8 funders, identifying 14 key outcome categories that are most important for evaluating prosthetic interventions.

The established PI-COS focuses on critical areas such as mobility, sensory functions, and general tasks, which can guide future clinical practices and research in prosthetics, ensuring that the outcomes measured align with user and funder priorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Core Outcome Set for users and funders of lower-limb prosthetic interventions (PI-COS): a step to inform the benefits measured in prosthetic health economic evaluations. Clarke, L., Ridgewell, E., Dillon, MP.[2023]

Citations

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Deploying Digital Prosthetic Interface Technology and ... The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb ...

2. withpower.com withpower.com/trial/phase-2-diabetes-mellitus-type-2-2023-6d639

Digital Prosthetics + Exercise for Diabetic Amputation Digital Prosthetic Interface Technology is unique because it uses foot movements to control prosthetic limbs, allowing for simultaneous activation of multiple ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11325936/

Advances in AI-based prosthetics development: editorial A key area of progress in prosthetics is artificial intelligence (AI), which is a large aspect of robotics. AI refers to a machine's ability to think and act ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10824968/

Advances in prosthetic technology: a perspective on ethical ... This article, based on current literature, presents perspectives surrounding ethical considerations from the authors' multidisciplinary views as prosthetists.

5. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2024.1454262/full

Recent progress on smart lower prosthetic limbs This review paper explores recent advancements in the integration of EEG and fNIRS modalities for smart lower prosthetic limbs for rehabilitation applications.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086952/

Investigating the Feasibility and Safety of Osseointegration ... Osseointegration combined with advanced neural interfaces represents a transformative approach to prosthetic control, offering more natural and ...

7. mdpi.com mdpi.com/2075-1702/13/9/804

Robotic Prostheses and Neuromuscular Interfaces This work provides a narrative state-of-the-art review regarding recent developments in robotic prosthetic technology, emphasizing sensor integration, actuator ...