Custom 3D Printed Insoles for Diabetes Foot Health

(3D Insole Trial)

Overseen By Brittney C Muir, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Foot ulcer, Amputation, Non-ambulatory, Terminal illness, others

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

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

In this research study, the investigators are evaluating if novel custom foot orthotics improves foot health and mobility for people who are at increased risk of developing foot ulcers. The investigators are comparing different methods of custom foot orthotic fabrication in people who are at increased risk of developing foot ulcers and individuals who are not. Participating in this study involves coming to the VA Hospital in Seattle for up to 12 study visits, lasting up to four hours. If eligible and choose to participate, participants will: * Wear custom foot orthotics during in laboratory testing for up to four hours * Receive a foot health assessment * Walk through the laboratory space so the investigators can see how the orthotics affect the participant's body movement * Participants will be paid for participating in the study

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that Custom 3D Printed Insoles for Diabetes Foot Health is an effective treatment?

The available research shows that Custom 3D Printed Insoles for Diabetes Foot Health are effective in reducing pressure on the foot, which is important for preventing complications like ulcers in diabetic patients. One study found that these insoles reduced plantar pressure more effectively than standard insoles. Another study demonstrated that 3D printed insoles, optimized using virtual simulations, significantly lowered peak pressures in the foot compared to traditional shape-based insoles. This suggests that 3D printed insoles can offer better protection and comfort for people with diabetes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Custom 3D Printed Insoles for Diabetes Foot Health?

Research shows that 3D-printed insoles can improve foot pressure distribution and reduce peak plantar pressures, which is beneficial for people with diabetes who are at risk of foot ulcers. These insoles have been shown to match or improve durability and reduce pressure compared to standard insoles, making them a promising option for diabetic foot health. ^{1 2 3 4 6}

What safety data exists for 3D printed insoles for diabetes foot health?

The safety data for 3D printed insoles, including those for diabetes foot health, indicates several benefits and considerations. Studies show that 3D printed insoles can improve foot pressure distribution, reduce peak pressure under the heel, and provide a personalized fit that may reduce injury risk. They have been evaluated for conditions like flatfoot and foot deformities, showing significant improvements in clinical scores and cost-effectiveness compared to standard insoles. Additionally, 3D printed insoles have demonstrated high accuracy, reduced plantar pressure, and improved durability compared to traditional methods. However, some discomfort under the arch region has been reported, and further research is needed to fully understand their long-term safety and efficacy in diabetic patients. ^{2 3 7 8 9}

Are 3D printed insoles safe for use in humans?

Research on 3D printed insoles, including those for diabetes foot health, suggests they are generally safe for use in humans. Studies have shown that these insoles can improve foot pressure distribution and reduce discomfort, with no significant safety concerns reported. ^{2 3 7 8 9}

Is the 3D Printed Insole treatment a promising treatment for diabetes foot health?

Yes, 3D Printed Insoles are promising for diabetes foot health. They can be customized to fit a person's foot perfectly, which helps distribute pressure evenly and reduce the risk of foot injuries. This is especially important for people with diabetes, who are at higher risk for foot problems. The insoles are made using advanced 3D printing technology, which allows for precise adjustments to the insole's stiffness and shape based on individual needs. This personalized approach can improve comfort and reduce pain, making it a valuable treatment option. ^{2 3 8 9 10}

How is the 3D Printed Insole treatment for diabetes foot health different from other treatments?

The 3D Printed Insole treatment for diabetes foot health is unique because it uses advanced 3D printing technology to create custom insoles that are tailored to the individual's foot shape and pressure distribution. This personalized approach can improve foot pressure distribution and reduce plantar pressure, potentially offering better comfort and effectiveness compared to standard insoles that are made using traditional methods like milling and hand carving. ^{2 3 8 9 10}

Research Team

Brittney C Muir, PhD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Eligibility Criteria

This trial is for adults over 18 with diabetes who need custom foot orthotics and have high plantar pressure. It's not for those with recent foot ulcers, terminal illness, special footwear needs beyond insoles, non-ambulatory individuals, pregnant women, or those unable to consent.

Inclusion Criteria

I have a prescription for diabetic foot supports.

Plantar pressure greater than or equal to 250 KPa (assessed at first study visit)

Exclusion Criteria

I cannot walk by myself.

Pregnant (determined by self-report)

Terminal illness that would make two-year survival unlikely

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive custom foot orthotics and undergo laboratory testing to evaluate foot health and mobility

4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 3D Printed Insole - FEA
• 3D Printed Insole - Pressure Based
• Standard of Care Insole

Trial Overview The study tests if custom-made diabetic insoles created using two different 3D printing methods can improve foot health and mobility compared to standard care insoles. Participants will visit the VA Hospital in Seattle up to 12 times for assessments.

Participant Groups

Group I: Diabetic with elevated plantar pressure Experimental Treatment 3 Interventions

Diabetic with elevated plantar pressure

3D Printed Insole - FEA is already approved in European Union, United States for the following indications:

Approved in European Union as 3D Printed Custom Orthotics for:

• Diabetic foot ulcers prevention
• Foot health improvement

Approved in United States as 3D Printed Diabetic Foot Insoles for:

• Diabetic foot ulcers prevention
• Foot health improvement

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Customized 3D-printed insoles for individuals with flexible flatfoot showed significant improvements in ankle movement and pressure distribution during gait, indicating their potential effectiveness in managing foot deformities.

The study found that stronger arch support features did not always lead to better outcomes, suggesting that careful design adjustments are necessary to avoid issues like over-cutting or impingement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Three-Dimensional Printed Foot Orthosis for Flexible Flatfoot: An Exploratory Biomechanical Study on Arch Support Reinforcement and Undercut. Cheng, KW., Peng, Y., Chen, TL., et al.[2021]

The study involving 30 healthy male participants demonstrated that a customized 3D-printed heel support insole significantly reduced peak pressure under the heel compared to traditional insoles, indicating improved pressure distribution.

Using the customized insole did not negatively affect midfoot motion function, suggesting it can enhance comfort without compromising foot function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 3D-Printed Heel Support Insoles Based on Arch Lift Improves Foot Pressure Distribution in Healthy People. Jin, H., Xu, R., Wang, S., et al.[2020]

Custom 3D printed insoles for diabetic patients can be designed to vary in stiffness based on individual plantar pressure measurements, potentially improving comfort and effectiveness compared to traditional insoles.

In a clinical case study, these 3D printed insoles demonstrated equal or better durability, reduced shear stiffness, and lower plantar pressure compared to standard accommodative insoles, suggesting a promising advancement in diabetic foot care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel workflow to fabricate a patient-specific 3D printed accommodative foot orthosis with personalized latticed metamaterial. Hudak, YF., Li, JS., Cullum, S., et al.[2022]

In a study involving 20 participants with diabetes at risk of foot ulceration, insoles designed using virtual optimization techniques significantly reduced peak plantar pressures by an average of 41.3 kPa for milled insoles and 40.5 kPa for 3D printed insoles compared to traditional shape-based devices.

The virtually optimized insoles outperformed shape-based insoles in 88% of the tested regions, demonstrating enhanced plantar tissue protection and suggesting that numerical modeling can improve the design of therapeutic footwear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtually optimized insoles for offloading the diabetic foot: A randomized crossover study. Telfer, S., Woodburn, J., Collier, A., et al.[2022]

A novel method for designing therapeutic insoles using advanced technologies like CAD/CAM and 3D digitization was developed to prevent foot sole ulcers in diabetic patients.

The study evaluated the effectiveness of four different types of insoles in reducing plantar pressure, highlighting the potential benefits of the computer-assisted design method over traditional manufacturing techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of moulded insoles in reducing plantar pressure in diabetic patients. Zequera, M., Stephan, S., Paul, J.[2020]

A new condition called triad of foot deformities (TFD) includes hallux valgus, flatfoot, and calcaneal spur, and can be effectively treated with a customized 3D-printed insole.

The study demonstrated that the 3D insole significantly improved patient outcomes, as shown by better AOFAS and FHSQ scores, while also being cost-effective at about one-third the price of standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triad of foot deformities and its conservative treatment: With a 3D customized insole. Yildiz, K., Medetalibeyoglu, F., Kaymaz, I., et al.[2021]

Personalised insoles created using 3-D foot scanning and additive manufacturing significantly reduced discomfort in the heel area and improved overall fit for runners compared to standard insoles, based on a study with 38 participants over 3 months.

Biomechanical analysis showed that runners using personalised insoles experienced lower ankle dorsiflexion at footstrike and reduced peak pressure under the heel, which may help lower the risk of injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of personalised insoles developed using additive manufacturing. Salles, AS., Gyi, DE.[2013]

A new method using a 3D printer to create customized orthopedic insoles from photo-curable polyurethane acrylate (PUA) composite resins shows promise for treating flatfoot, offering high accuracy and adjustable hardness.

The 3D-printed insoles demonstrated lower stress and displacement under weight compared to traditional ethylene vinyl acetate (EVA) insoles, suggesting they can better reduce plantar pressure and resist deformation, making them effective for foot disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photocurable and elastic polyurethane based on polyether glycol with adjustable hardness for 3D printing customized flatfoot orthosis. Zhao, Y., Zhong, J., Wang, Y., et al.[2023]

Customized 3D printed ankle-foot orthoses (AFOs) significantly improved comfort and reduced peak pressure in key areas of the foot for patients with plantar fasciitis compared to traditional prefabricated AFOs, as shown in a study of 60 patients over 8 weeks.

After 8 weeks, patients using the customized AFOs reported significantly greater comfort levels than those using prefabricated AFOs, indicating that customized solutions may be more effective in managing plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 3D Printing Individualized Ankle-Foot Orthosis on Plantar Biomechanics and Pain in Patients with Plantar Fasciitis: A Randomized Controlled Trial. Xu, R., Wang, Z., Ma, T., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Three-Dimensional Printed Foot Orthosis for Flexible Flatfoot: An Exploratory Biomechanical Study on Arch Support Reinforcement and Undercut. [2021]

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

Use of 3D-Printed Heel Support Insoles Based on Arch Lift Improves Foot Pressure Distribution in Healthy People. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A novel workflow to fabricate a patient-specific 3D printed accommodative foot orthosis with personalized latticed metamaterial. [2022]

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

Virtually optimized insoles for offloading the diabetic foot: A randomized crossover study. [2022]

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

Effectiveness of moulded insoles in reducing plantar pressure in diabetic patients. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Pressure relief and load redistribution by custom-made insoles in diabetic patients with neuropathy and foot deformity. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Triad of foot deformities and its conservative treatment: With a 3D customized insole. [2021]

8. England pubmed.ncbi.nlm.nih.gov

An evaluation of personalised insoles developed using additive manufacturing. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Photocurable and elastic polyurethane based on polyether glycol with adjustable hardness for 3D printing customized flatfoot orthosis. [2023]

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

Effect of 3D Printing Individualized Ankle-Foot Orthosis on Plantar Biomechanics and Pain in Patients with Plantar Fasciitis: A Randomized Controlled Trial. [2020]