# Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

> **NIH VA I01** · VA PUGET SOUND HEALTHCARE SYSTEM · 2024 · —

## Abstract

It is estimated that, globally, a lower extremity amputation takes place every 30 seconds, and that 85% of
these amputations are the result of diabetic foot ulcers. Plantar foot ulcers develop, in part, due to high
loading and mechanical stress to the soft tissues of the foot. Custom standard of care insoles aim to reduce
regions of the foot that experience excessive plantar pressures by redistributing pressure to other areas.
Limitations in the effectiveness of standard of care insoles, however, result in rates of ulceration that remain
unacceptably high. Meanwhile, a revolution in 3D printing technologies, material properties, and digital
manufacturing pipelines are enabling a wave of innovative solutions that are improving outcomes in many
areas of medicine. We aim to leverage these techniques to create novel patient-specific 3D printed insoles
with personalized metamaterials which we believe will demonstrate superior offloading performance.
Personalized metamaterials are 3D printed materials formed from lattice patterns derived from patient-
specific characteristics, resulting in insoles that are uniquely matched to the patient’s needs. The aim of
this study is to determine if 3D printed insoles with personalized metamaterials reduce plantar pressures
for at-risk areas of the foot better than standard of care insoles. We will manufacture three different insoles,
namely the standard of care (SC), 3D printed pressure based (3DP-PB), and finite element optimized
(3DP-FE) insoles. 3DP-PB insoles will be designed from plantar foot shape and dynamic plantar pressure
while the 3DP-FE insoles will be designed from simulations of participant’s feet interacting with different
insole designs to optimize the insole shape and metamaterial properties. In a repeated measures study,
we will measure peak plantar pressure and pressure time integral for each type of insole with a group of
25 participants who have diabetes and elevated forefoot pressure. We hypothesize that the 3D printed
insoles comprised of personalized metamaterials derived from plantar measurements (3DP-PB) will have
greater reductions in the peak plantar pressure and pressure time integral than the SC insoles (H1).
Additionally, we hypothesize that, relative to the other two insoles, insoles optimized through patient-
specific finite element simulations (3DP-FE) will have the greatest reduction in peak plantar pressure and
pressure time integral (H2). To facilitate the clinical translation of the novel 3D printed insoles we will carry
out focus groups with patients and clinicians to gain their early feedback and insights. Results from these
focus groups will be qualitatively synthesized into actionable improvements to the insoles. Novel insoles
that utilize 3D printing fabrication may provide enhanced protection from foot ulcers that frequently
progress to amputation. Moreover, digital manufacturing technologies and 3D fabrication methods have
relatively low barriers to mass production, whi...

## Key facts

- **NIH application ID:** 10793530
- **Project number:** 5I01RX003539-03
- **Recipient organization:** VA PUGET SOUND HEALTHCARE SYSTEM
- **Principal Investigator:** Brittney C Muir
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2022-04-01 → 2026-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10793530

## Citation

> US National Institutes of Health, RePORTER application 10793530, Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure (5I01RX003539-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10793530. Licensed CC0.

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