3D-Printed Insoles for People with Type 2 Diabetes: An Italian, Ambulatory Case Report on the Innovative Care Model

Abstract

3D-printed insoles are increasingly used for the management of foot pathologies, and the recent literature reports on various experimental studies dealing with either whole foot orthoses or pads fabricated through 3D-printing processes. In the case of diabetic foot disease, the main aim is to deliver more effective solutions with respect to the consolidated processes to reduce compressive risk forces at specific plantar foot sites. Clinical studies are, however, still limited, at least in peer-review journals. Additionally, in Italy, the manufacturing process of these medical devices has not been formally integrated yet into the list of care processes approved for reimbursement by the public healthcare service. Within the Italian DIAPASON project (DIAbetic PAtients Safe ambulatiON), a feasibility pilot study has been conducted in the territory on 21 patients with diabetic foot complications to assess the pros and cons of an innovative process. The process, which relies on in-shoe pressure measurements and on a patented 3D modeling and printing procedure, includes the prescription, design, manufacturing and testing of 3D-printed personalized insoles. The process has been tested in an ambulatory setting and showed the potential to be also implemented in community settings. 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 purpose.

3D printing and bioprinting in the battle against diabetes and its chronic complications

“…Though these SoC insoles are customized, these still do possess a drawback of being dependent on the generic properties of materials. However, recent research has evidenced the 3D Printing strategy could be employed to circumvent this drawback by relying on individualized materials in the fabrication of diabetic-friendly personalized insoles ( Mancuso et al, 2023 ). Mancuso et al (2023) conducted a pilot study named “DIAPASON” (DIAbetic PAtients Safe ambulatiON) and studied the safety of 3D-printed insoles, when used by an italian patient with foot complications associated with T2D in an ambulatory setting ( Mancuso et al, 2023 ).…”

“…In the past few days, integration of 3D printing, scanning, materials chemistry and software application have been highly beneficial in fine-tuning the procedure of insole fabrication process and in enhancing the performance of insoles as well ( Zuniga et al, 2022 ; Mancuso et al, 2023 ). For instance, Zuniga et al (2022) developed 3D-printed insoles employing the thermoplastic polyether-polyurethane and thermoplastic polyurethane polyester-based polymer for diabetic patients and evaluated its efficiency in plantar pressure distribution with electronic pressure sensors ( Zuniga et al, 2022 ).…”