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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether special 3D printed insoles can improve foot health and movement in people with diabetes who may develop foot ulcers. The study compares different methods of creating these custom insoles, including the 3D Printed Insole - FEA and the 3D Printed Insole - Pressure Based. It seeks participants with diabetes who use custom foot orthotics and experience high pressure on the bottom of their feet. Sessions will occur at the VA Hospital in Seattle, and participants will receive compensation for their time. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance foot care for diabetic patients.

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 prior data suggests that these custom 3D printed insoles are safe for diabetic foot health?

Research has shown that 3D-printed insoles are safe for people with diabetes. In one study, participants used these insoles without harmful effects during a short trial. The insoles help reduce pressure on the feet, which can prevent ulcers.

A case study found that 3D-printed insoles were safe and suitable for people with type 2 diabetes. This indicates that the insoles are well-tolerated and do not cause negative side effects.

Overall, using these insoles in clinical settings has demonstrated promising safety results, making them a reliable option for those at risk of foot problems due to diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these 3D printed insoles for diabetes foot health because they offer a personalized approach to managing elevated plantar pressure, a common issue for diabetics. Unlike the standard insoles that provide a one-size-fits-all solution, these insoles can be customized using Finite Element Analysis (FEA) or pressure-based designs to better distribute pressure across the foot. This tailored fit aims to prevent foot ulcers more effectively, potentially reducing complications and improving quality of life for diabetic patients.

What evidence suggests that these custom 3D printed insoles are effective for improving foot health in people at risk of foot ulcers?

Research shows that 3D-printed insoles can make walking more comfortable and help prevent foot ulcers in people with diabetes. In this trial, participants may receive one of the 3D-printed insoles, either designed using a method called Finite Element Analysis (FEA) or based on pressure reduction. Studies have found that these insoles reduce pressure on the feet, especially in areas where ulcers are likely to form. Evidence suggests that FEA-designed insoles help manage conditions like diabetic peripheral neuropathy by lowering pressure. Meanwhile, insoles focusing on reducing pressure improve balance and lessen pressure on high-risk areas. Overall, these insoles show great promise in preventing foot problems related to diabetes. ^{1 2 3 6 7}

Who Is on the Research Team?

Brittney C Muir, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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)

I need special footwear for my daily activities.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05301478

Patient Specific 3D Printed Diabetic Insoles to Reduce ... In this research study, the investigators are evaluating if novel custom foot orthotics improves foot health and mobility for people who are at increased ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11831857/

Comparative Efficacy of 3D-Printed Insoles in Managing ... The findings revealed that patients with flexible flatfoot, diabetic foot ulcers, and plantar fasciitis reported greater comfort with 3D-printed insoles ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268003325002268

Effects of standard of care and pressure-based 3D-printed ... This pilot study provides useful information on how the custom accommodative insoles used to prevent ulcers in individuals with diabetes affect ...

4. medrxiv.org medrxiv.org/content/medrxiv/early/2025/08/11/2025.08.07.25333211.full.pdf

3D-Printed Custom Accommodative Insoles Outperform ... The reduction in plantar pressure, especially in regions at high risk of ulceration, is critical in preventing diabetic foot ulcers. The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12400727/

The current state of 3D-printed orthoses clinical outcomes 3D-printed insoles with snapping arches effectively reduce plantar pressure in patients with diabetic peripheral neuropathy, potentially ...

6. mdpi.com mdpi.com/2673-4540/4/3/29

3D-Printed Insoles for People with Type 2 Diabetes In this paper, we report a case study on a single volunteer, and we describe and comment on how the whole process has been proven safe and suitable for the ...

7. medrxiv.org medrxiv.org/content/10.1101/2025.08.07.25333211v1.full-text

Improving Offloading in Diabetic Feet: 3D-Printed Custom ... Custom accommodative insoles are prescribed to patients with diabetes who are at risk of developing plantar ulcers (8,9). Custom insoles aim to ...