Progress of additive manufacturing in fabrication of foot orthoses for diabetic patients: A review

Chhikara, Komal; Singh, Gurpreet; Gupta, Shubham; Chanda, Arnab

doi:10.1016/j.stlm.2022.100085

Cited by 14 publications

(7 citation statements)

References 63 publications

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“…The multipurpose customized orthotic device was designed for and fabricated using 3D printing as it presented certain benefits. Three-dimensional printing allowed for the better customizability and precision of the orthosis [30][31][32]. The multipurpose customized orthotic device incorporated the manual angulation of the wrist joint for performing the activities of daily living.…”

Section: Discussionmentioning

confidence: 99%

Development and Trial of a Multipurpose Customized Orthosis for Activities of Daily Living in Patients with Spinal Cord Injury

et al. 2023

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People with mid-cervical spinal cord injury (SCI) often have difficulty in performing activities of daily living due to weakness or paralysis in the flexor muscles. The inability to perform activities requiring fine motor control, such as eating, brushing, writing, unlocking doors, etc., affects overall quality of life negatively. To perform such tasks, appropriate movement of the hands, specifically at the wrist, is essential. For SCI patients, wrist orthotics are considered a viable option with which to perform general tasks. Wrist orthotics, used for rehabilitating people with SCI, help to maintain proper wrist and hand positioning; however, patients must frequently change these orthotic devices as per separate activity requirements. This becomes difficult and cumbersome for such patients. In this work, a passive 3D-printed upper-extremity dynamic orthosis was developed to assist SCI patients in their activities of daily living. The orthosis works on the principle of a worm-gear-based mechanism to produce pronation/supination motions at the wrist. To test the developed multipurpose customized orthosis, ten patients with cervical SCI were recruited and prescribed the 3D-printed splint for a period of four weeks. It was assessed through the QUEST questionnaire and a task completion assessment for its performance. The developed multipurpose customized orthotic device was found to provide an appropriate range of motion, ease in performing tasks, and took less time to complete tasks compared to previous works. The results indicated satisfactory performance, thereby improving quality of life. The multipurpose customized orthotic device successfully assisted the subjects with their daily activities, thus making them more independent in their rehabilitative period.

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Section: Discussionmentioning

confidence: 99%

Development and Trial of a Multipurpose Customized Orthosis for Activities of Daily Living in Patients with Spinal Cord Injury

et al. 2023

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“… Telfer et al (2014) identified footwear material elasticity as the most influential factor in pressure offloading. Studies comparing pressure offloading performance across different insole materials ( Ma et al, 2019 ; Nouman et al, 2019 ; Tang et al, 2019 ; Chhikara et al, 2022 ) provide practical information for clinical prevention, guiding the design of more suitable insoles for diabetic patients. Soft insole materials, such as PORON Medical 4,708 and Nora Lunalastik EVA, outperformed rigid materials like Nora Lunalight A fresh and Pe-Lite in plantar pressure offloading for diabetic elderly individuals ( Shi et al, 2022 ).…”

Section: Design Of Diabetic Foot Insolesmentioning

confidence: 99%

Advancements in diabetic foot insoles: a comprehensive review of design, manufacturing, and performance evaluation

Ren,

Wang,

Song

et al. 2024

Front. Bioeng. Biotechnol.

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The escalating prevalence of diabetes has accentuated the significance of addressing the associated diabetic foot problem as a major public health concern. Effectively offloading plantar pressure stands out as a crucial factor in preventing diabetic foot complications. This review comprehensively examines the design, manufacturing, and evaluation strategies employed in the development of diabetic foot insoles. Furthermore, it offers innovative insights and guidance for enhancing their performance and facilitating clinical applications. Insoles designed with total contact customization, utilizing softer and highly absorbent materials, as well as incorporating elliptical porous structures or triply periodic minimal surface structures, prove to be more adept at preventing diabetic foot complications. Fused Deposition Modeling is commonly employed for manufacturing; however, due to limitations in printing complex structures, Selective Laser Sintering is recommended for intricate insole designs. Preceding clinical implementation, in silico and in vitro testing methodologies play a crucial role in thoroughly evaluating the pressure-offloading efficacy of these insoles. Future research directions include advancing inverse design through machine learning, exploring topology optimization for lightweight solutions, integrating flexible sensor configurations, and innovating new skin-like materials tailored for diabetic foot insoles. These endeavors aim to further propel the development and effectiveness of diabetic foot management strategies. Future research avenues should explore inverse design methodologies based on machine learning, topology optimization for lightweight structures, the integration of flexible sensors, and the development of novel skin-like materials specifically tailored for diabetic foot insoles. Advancements in these areas hold promise for further enhancing the effectiveness and applicability of diabetic foot prevention measures.

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“…Chhikara et al [16] recently conducted a valuable review on the effectiveness of 3Dprinted orthoses for diabetic foot management. They reported on the following human subject studies: Telfer et al [17] compared standard milled insoles with 3D-printed insoles in 20 patients with type 2 diabetes and proved that the former performed better than the latter in improving plantar offloading.…”

Section: D-printed Insoles: Feedback From the Recent Literaturementioning

confidence: 99%

“…Hudak et al [10] enrolled one patient with diabetes to compare an SoC insole, a hybrid 3D-printed insole with a bi-laminate foam top, and a fully 3D-printed insole: the latter showed improved durability, reduced shear stiffness and lower plantar pressures. The authors of review [16] concluded that: the available literature on development of 3D-printed orthosis for patients with Diabetes is still limited; more generally, the 3D-printed orthoses demonstrated equivalent performance in clinical aspect; 3D-printing process may bring to biomechanical changes in the foot, however further validation is required to confirm that these changes can indeed be associated with clinically relevant outcomes; additive manufacturing applied to the diabetic foot management may benefit of the integration with Finite Elements Analysis (FEA), biomechanical measurements and modelling; there is still a lack of orthoses for post-ulcer diabetic foot and 3D-printed insoles impact as an intervention against the foot ulcer progression is yet to be tested [20]; patients with partial foot amputations can also be managed using 3D-printed partial foot orthosis [21,22]. Shaikh et al [23] conducted quite an extensive, experimental study involving 200 patients suffering from various foot-related problems and joint pain; 18 of them (38-69 years old) suffered from diabetic foot complications.…”

Section: D-printed Insoles: Feedback From the Recent Literaturementioning

confidence: 99%

“…Evidence from robust clinical studies is still lacking in the literature; however, pioneering papers confirm the mandatory safety and the potential effectiveness of personalized materials and graded stiffness and of the overall innovative approach, either specifically for diabetic foot management or with reference to other foot pathologies, such as a flat foot or the high-arched foot [8][9][10][11][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]. A more detailed digression of the relevant literature is reported in the Discussion section.…”

Section: Introductionmentioning

confidence: 99%

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

Mancuso,

Bulzomì,

Mannisi

et al. 2023

Diabetology

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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.

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Progress of additive manufacturing in fabrication of foot orthoses for diabetic patients: A review

Cited by 14 publications

References 63 publications

Development and Trial of a Multipurpose Customized Orthosis for Activities of Daily Living in Patients with Spinal Cord Injury

Development and Trial of a Multipurpose Customized Orthosis for Activities of Daily Living in Patients with Spinal Cord Injury

Advancements in diabetic foot insoles: a comprehensive review of design, manufacturing, and performance evaluation

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

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