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Insoles and shoes. A) The contours of the custom-made insoles composed of ethylene vinyl acetate (EVA) with a standardized metatarsal bar. B) Prefabricated insole GloboTec® Comfort 312750501400 (GloboTec, Bauerfeind, Germany), with support of the medial arch and a metatarsal pad in the forefoot in a material with a core (reinforcement element) that consists of a mixture of thermoplastic, polyurethane, polyester, and polycarbonate. The cushioning material is foam that belongs to the chemical family of urethane polymers with a shore density of about 12 shore A. The cover is a 2-mm layer of microfiber, consisting of polyester and polyurethane. C) Photograph of a representative walking shoe used in the study (Opara Deluxe men 809159, ladies 8807159; Erimed, Stockholm, Sweden). The shoe has a semi-rigid outer sole, a stable heel counter, and adjustable lacing. The maximum height of the toe box is 40 mm vs. 43 mm for EUR size 38/Women last vs 45/Men last. D) An example of a custom-made insole that is ready to be exchanged due to the presence of cracks and breakdown areas.
Source publication
Background: Special insoles and shoes designed to prevent foot ulcers caused by repetitive high pressures are recommended for patients with diabetes who have any of the following risk factors: neuropathy; peripheral vascular disease; foot deformities; previous ulcers; amputation; and skin pathologies. However, there is a need for increased knowledg...
Contexts in source publication
Context 1
... heating and vacuum formation of the 14-mm-thick EVA material followed the distributor's recommendations (E603442, E603402; Össur Nordic, Uppsala, Sweden). Patients in the control group received prefabricated insoles (GloboTec Ò Comfort 312750501400; Globo- Tec, Bauerfeind, Germany) (Figure 1). One technician fabricated all the individual insoles with a standardized metatarsal bar proximal to metatarsal heads IIeIV. ...Context 2
... insoles were adjusted to fit into the participant's shoes, which were designed to be used outdoors. All the shoes had a semi-rigid outer sole or stiff rocker bottom, a stable heel counter, and adjustable laces or Velcro straps (Figure 1). Upon manufacturing, the shoes were checked, to ensure that they met all the set criteria. ...Context 3
... adjustments to the insoles during the study period were registered in the cate- gories of: higher or lower metatarsal bar; more lateral or medial support; and more material under the heel. New insoles were supplied when any cracks or breakdown areas in the insoles were detected at follow-up (Figure 1). At baseline, the self-reported status was recorded, which included the duration of diabetes, type of diabetes, glycated hemoglobin (HbA1c) level, use of medi- cation, use of nicotine, and ability to walk normally (yes/no). ...Context 4
... maxPP is the highest pressure sensed within each of the seven ROI over the same number of footsteps. The calculation PTI followed the equation: where P1 is the total pressure present in the first frame of the stance, T1 is the duration (time) of the first frame of the stance, PN is the total pressure present in the last frame of the stance, and TN is the duration of the final frame of the stance (from F-Scan User Manual 6.62, Rev H). Stance number 3 was selected for the analysis of PTI, as measured in kiloPascals  second. ...Context 5
... reduction in the heel region is probably due to the casting procedure, which entails tight molding that follows the contour of the heel. A three-dimensional view of a custom-made insole (Figure 1) shows a narrow heel width together with high edges, which retain the heel pad under the bony prominences of the calcaneus, thereby providing cushioning. Thus adjusting the prefabricated insoles with higher edges that are positioned tight to the heel can be assumed to improve the pressure reduction properties. ...Citations
... Footwear, including custom-made and medical-grade footwear, plays an important role in the prevention of primary and recurrence of ulceration. Diabetes Feet Australia (DFA) guidelines on footwear for people with diabetes recommend prescription guidelines on footwear and insoles design and modifications for effective offloading of the peak plantar pressure at forefoot regions [5][6][7][8][9][10][11][12][13][14][15][16][17][18]. Guidelines also recommend the involvement of footwear specialists such as pedorthists in the management of the at-risk foot [19,20]. ...
Diabetes-related foot complications, including neuropathic plantar forefoot ulcers, are a significant contributor to morbidity and increased healthcare costs. This retrospective clinical audit examines the characteristics of people accessing pedorthics services who are at risk of neuropathic plantar forefoot ulcer (re)occurrence and the pathways and funding models used to access these services. A clinical record audit was conducted on all patients accessing a pedorthics service who had diabetes and neuropathy with a history of plantar forefoot ulceration. The data included demographics, diabetes and neuropathy duration, main forefoot pathology and other comorbidity, footwear and insole interventions, and health fund access status. A total of 70 patient records were accessed, and relevant data was extracted. The mean age of participants was 64.69 (standard deviation (SD) 11.78) years; 61% were male and 39% female. Duration of diabetes ranged from one to 35 years, with a mean of 14.09 years (SD 6.58). The mean duration of neuropathy was 8.56 (SD 4.16) years. The most common forefoot conditions were bony prominences at 71% (n = 50), rigid flat foot and limited joint mobility (53%, n = 37), and hallux abductovalgus at 47% (n = 33). All participants had hyperkeratosis; 34% (n = 24) had forefoot amputation, and around 34% (n = 24) had a history of digital amputation. Various publicly funded packages and private health insurance were accessed. This study investigates the sociodemographic and medical profiles of individuals with diabetes-related foot complexities prone to neuropathic plantar forefoot ulcers. It is the first to examine patients receiving pedorthic services, informing practitioner surveys and preventive care strategies. Understanding patient characteristics aids in optimising multidisciplinary care and reducing ulcer incidence. Further studies are warranted to explore the field to establish an effective multidisciplinary care approach between medical professionals, podiatrists and pedorthists to optimise patient outcomes.
... Additionally, custom insoles have been shown to significantly offload plantar pressure in both the forefoot and rearfoot regions of the foot, which has not been observed in prefabricated insoles. Thus, custom insoles can help to reduce the pressures at the important foot locations and thereby minimize the risk of injury or discomfort and support overall foot health [32][33][34]. However, producing custom insoles is a tedious process requiring significant attention to detail [35,36]. ...
The number of people with diabetes is rising day-by-day, which also raises the incidence of diabetic ulcers, sensation loss in the foot’s plantar area, and in extreme instances, amputations. Using customized shoes, unloading orthoses, insoles, and other strategies may help control these issues to some degree. In this work, a novel modular diabetic insole was designed and fabricated to effectively offload the abnormal or peak plantar pressures in diabetic patients. The pressure values in the plantar region were quantified using an in-house-developed plantar pressure-measuring insole consisting of force sensitive resistor (FSR) sensors. The effectiveness of the modular diabetic insole was tested qualitatively and quantitatively. The qualitative performance of the insole was reported using Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) in terms of subjective parameters like comfort, ease of use, effectiveness, etc. and calculated as 4.7 ± 0.18. Thereafter, the wearable pressure-measuring insole was used to investigate the feasibility of modular insole for the plantar pressure offloading during standing and walking conditions. It was observed that the maximum average zonal pressure (AZP) was reduced by up to 99% from 121.30 ± 3.72 kPa to 0.22 ± 0.18 kPa for the standing condition whereas it was reduced to 6.76 ± 2.03 kPa from 197.71 ± 3.21 kPa with a percentage value of 96% for the walking condition. In conclusion, the findings of this work validate the effectiveness of the modular diabetic insole as an intervention tool for diabetic foot ulcer prevention.
... A critical measure for evaluating the effectiveness of the suggested designs and materials selections is to compare the maximum plantar pressure value obtained to an assigned acceptable level. Many studies have identified 200 kPa as the top limit for successful foot offloading in diabetic patients (Bus et al., 2011;Hellstrand Tang et al., 2014;Lin et al., 2013;Martinez-Santos et al., 2019;Owings et al., 2009). When comparing CMI-I to CMI-II regarding the FE-predicted peak contact stress on the foot, CMI-II produced higher values for all materials used, except for Plastazote PE. ...
... [18][19][20][21] The design of insole was adjusted according to the personalized parameters. [22][23][24] In order to meet the requirements, it is necessary to use the patient's CT imaging data to generate a 3D printed insole through 3D printing. [25][26][27] The CLI patients' ultrasonic hemodynamic parameters of plantar artery would be monitored at 1, 3, 6 and 12 months after treatment. ...
Introduction
Critical limb ischemia (CLI) is a severe condition characterized by inadequate blood flow to the lower extremities, often leading to tissue damage and amputation. CLI is characterized by microcirculatory dysfunction, muscle tissue necrosis, and inflammation. Patients may suffer from the traumatic pain and the increase of plantar pressure, and foot care for patients with CLI has become the “last mile” to improve their life quality. Traditional shoe insoles often lack individual customization, failing to address the unique anatomical needs and hemodynamic characteristics of patients. The study aims to investigate the effects of this innovative intervention on improving the clinical outcomes, and quality of life in CLI patients.
Methods and Analysis
This Critical Limb Ischemia Hemodynamic Insole Study is a randomized controlled study performed to explore the effect of a 3D printing insole on foot care of CLI patients. This study recruitment began on November 1, 2021. Patients with CLI confirmed by clinical symptoms and imaging were recruited as the research objects. Participants will be randomly assigned to either the experimental group, which will receive 3D-printed insoles customized based on their hemodynamics, or the control group, which will receive traditionally manufactured insoles. Both groups were followed up for up to 24 months after surgery, including claudication distance, claudication time, pain score, rehospitalization, etc.
Trial Registration Number
ChiCTR2100051857.
... Footwear, including custom-made and medical-grade footwear, plays an important role in the prevention of primary and recurrence of ulceration. Diabetes Feet Australia (DFA) guidelines on footwear for people with diabetes recommend prescription guidelines on footwear and insoles design and modifications for effective offloading of the peak plantar pressure at forefoot regions (5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18). Guidelines also recommend the involvement of footwear specialists such as pedorthics in the management of the at-risk foot (3,4). ...
Background
Diabetes-related foot complications, including neuropathic plantar forefoot ulcers, are a significant contributor to morbidity and increased healthcare cost. This retrospective clinical audit examines the characteristics of people accessing pedorthics services who are at risk of neuropathic plantar forefoot ulcer (re)occurrence and the pathways and funding models used to access these services.
Methods
A clinical record audit was conducted on all patients accessing a pedorthics service who had diabetes and neuropathy with a history of plantar forefoot ulceration. The data included demographics, diabetes and neuropathy duration, main forefoot pathology and other comorbidity, footwear and insole interventions, and health fund access status.
Results
A total of 70 patient records were accessed, and relevant data was extracted. The mean age of participants was 64.69 (SD 11.78) years; 61% were male and 39% female. Duration of diabetes ranged from one to 35 years, with a mean of 14.09 years (SD 6.58). The mean duration of neuropathy was 8.56 (SD 4.16) years. The most common forefoot conditions were bony prominences at 71% (n=50), rigid flat foot and limited joint mobility (53%, n=37), and hallux abductovalgus at 47% (n=33).
All participants had hyperkeratosis; 34% (n=24) had forefoot amputation, and around 34% (n=24) had a history of digital amputation. Various publicly funded packages were accessed, as well as private health insurance.
Conclusion
This study explored the sociodemographic, pathology and comorbidity characteristics of the population with diabetes-related foot complexities who are at risk of neuropathic plantar forefoot ulcerations. By understanding the patient characteristics associated with accessing Pedorthic services, healthcare providers can enhance their strategies for preventive care, ultimately reducing the incidence of diabetes-related neuropathic foot ulcers and improving overall health. Further studies are warranted to explore the field to establish an effective multidisciplinary care approach between medical professionals, podiatrists and pedorthists to optimise patient outcomes.
Keywords: Diabetes, Neuropathy, Forefoot ulceration, Clinical audit, Plantar pressure offloading.
... The Morton's extension material chosen for this study is among the most commonly employed in the design of plantar orthoses [38][39][40][41]. The measurements conducted have been repeated extensively to ensure the reliability of the analytical data. ...
Background:
the area beneath the metatarsal heads is a common location of foot pain, which is often associated with high plantar pressures. The aim of this study was to determine the effect of the application of a Morton's extension on the pressure in the metatarsal bones of the foot using a pressure platform.
Methods:
twenty-five subjects without musculoskeletal pathology were selected for this study, and an experiment was conducted with them as the subjects, before and after application of a Morton's extension. The foot regions were divided into the forefoot (transversely subdivided into six areas corresponding to the first, second, third, fourth, and fifth metatarsal heads, and the hallux), midfoot, and rearfoot, and then the maximum and average pressures exerted at each region were measured before and after placing a Morton's extension.
Main findings:
we found a pressure reduction, with a p-value less than (p < 0.05), in the head of the second and third metatarsals in statics and dynamics.
Conclusions:
we can conclude that the Morton's extension produces a variation in plantar pressures on the lesser metatarsals. The application of a Morton's extension may be beneficial for the management of forefoot pathology. This study will help clinicians consider various tools to treat forefoot disorders. NCT05879094 (ClinicalTrial.gov (accessed on 18 May 2023)).
... Pressure measurement systems have numerous applications in healthcare. The most common use is in clinical gait analysis to assist in the prescription and assessment of interventions such as orthotics [1][2][3][4][5][6][7][8][9][10][11], surgery [12][13][14][15][16][17], medication [18] or rehabilitation programmes [19][20][21][22][23]. They can also be used to provide biofeedback if pressure mapping data is linked to a live display [24][25][26][27], and can therefore alert patients and clinicians if patients' plantar pressures are too high, so the patient or clinician can offload the area of high pressure, reducing the risk of pressure ulcers forming [27]. ...
... In-shoe systems are thus often used to assess dynamic sporting movements, and are particularly suited to measuring plantar pressures during running [29,31,[122][123][124][125]. As these systems fit within the shoe, they are very suitable for applications such as assessing the effect of different types of footwear on plantar pressure [4,46,49,51,75,95,103,[126][127][128][129][130][131][132], measuring plantar pressures inside sport-specific footwear [34,35,62,133,134] and helping to prescribe and assess the effect of orthotics in redistributing or reducing plantar pressures [9][10][11][135][136][137][138]. ...
Pressure measurement systems have numerous applications in healthcare and sport. The purpose of this review is to: (a) describe the brief history of the development of pressure sensors for clinical and sport applications, (b) discuss the design requirements for pressure measurement systems for different applications, (c) critique the suitability, reliability, and validity of commercial pressure measurement systems, and (d) suggest future directions for the development of pressure measurements systems in this area. Commercial pressure measurement systems generally use capacitive or resistive sensors, and typically capacitive sensors have been reported to be more valid and reliable than resistive sensors for prolonged use. It is important to acknowledge, however, that the selection of sensors is contingent upon the specific application requirements. Recent improvements in sensor and wireless technology and computational power have resulted in systems that have higher sensor density and sampling frequency with improved usability - thinner, lighter platforms, some of which are wireless, and reduced the obtrusiveness of in-shoe systems due to wireless data transmission and smaller data-logger and control units. Future developments of pressure sensors should focus on the design of systems that can measure or accurately predict shear stresses in conjunction with pressure, as it is thought the combination of both contributes to the development of pressure ulcers and diabetic plantar ulcers. The focus for the development of in-shoe pressure measurement systems is to minimise any potential interference to the patient or athlete, and to reduce power consumption of the wireless systems to improve the battery life, so these systems can be used to monitor daily activity. A potential solution to reduce the obtrusiveness of in-shoe systems include thin flexible pressure sensors which can be incorporated into socks. Although some experimental systems are available further work is needed to improve their validity and reliability.
... These are intended to assist reduce abnormal movement and can also aid in the treatment of chronic foot discomfort and the correct healing of injuries. Reducing planter contact pressure in diabetic individuals has been proven in studies to aid in the prevention of diabetic foot (Hellstrand Tang et al., 2014). ...
The orthotic insole is a device that is placed between the bottom of the foot and the sole of the shoe. It bears the body weight and directly influences the biomechanics of the foot and the body. These insoles are used to minimize the stress by reducing plantar pressure between support points hence minimizing the pressure. Such customized insoles have usually been produced by either handmade or subtractive methods. Fused deposition modeling (FDM) has opened innovative ways for the manufacture of orthotic insoles. In recent studies, no specific computer-aided design (CAD) tools are available to design and manufacture the insole, which is the primary focus. This work aims to evaluate established CAD techniques for designing and fabricating insoles utilizing different manufacturing processes. The evaluation is based on a prior analysis of the possibilities for functionalizing insole materials and structures. In this study, multiple software tools are utilized for designing custom insoles, considering pressure points and a three-dimensional (3D) foot scan of an individual. The research highlights how the implementation of software enables a significant level of customization by integrating pressure mapping data into the insole design process. A novel CAD approach for designing an orthotic insole has been provided in this work. Soft poly-lactic acid (PLA) is used to fabricate an insole using FDM technology. The gyroid and solid samples were evaluated following ASTM standards. When compared to the solid construction, the gyroid structure has a high specific energy absorption capability, which is used to create the orthotic insole. The results of the experiment suggest that the selection of the structure for customized insole design is significantly affected by the infill density parameter.
... Plantar pressure data were collected at 100 Hz using the Tekscan system (Wireless Tekscan Device, Boston, MA, USA) and analyzed using the F-Scan software (F-Scan Research 4.5) [9,[24][25][26]. The footprint was divided into 13 plantar foot regions to analyze the plantar pressure data. ...
This study aimed to investigate the effect of varying the hardness of prefabricated orthopedic insoles on plantar pressure and muscle fatigue during uphill walking with a heavy backpack. Fifteen healthy male recreational athletes (age: 20.4 ± 1.0 years, height: 176.9 ± 5.7 cm, weight: 76.5 ± 9.0 kg) wore prefabricated orthopedic insoles with foot arch support; a heel cup with medium (MI), hard (HI), and soft (SI) relative hardnesses; and flat insoles (FI). They performed treadmill walking on uphill gradients with 25 kg backpacks. The plantar pressure and surface electromyographic activity were recorded separately, in 30 s and 6 min uphill treadmill walking trials, respectively. The HI, MI, and SI significantly decreased peak plantar pressure in the lateral heel compared to FI. The MI and SI significantly decreased the peak plantar pressure in the fifth metatarsal compared to FI. The MI significantly reduced the pressure–time integral in the lateral heel compared to FI. The HI significantly increased the peak plantar pressure and pressure–time integral in the toes compared to other insoles, and decreased the contact area in the metatarsal compared to SI. In conclusion, a prefabricated orthopedic insole made of soft material at the fore- and rearfoot, with midfoot arch support and a heel cup, may augment the advantages of plantar pressure distribution during uphill weighted walking.
... The current reliability study was based on plantar pressure measurements in a cohort of PDs, from a 10-year follow-up study of the use of three different types of insole (Hellstrand [20]). At study start in 2008, the in-shoe pressure measurement was obtained using F-Scan® 6.10 software, while, at the 10-year follow-up, an upgraded version, F-Scan® 7.50 (Tekscan, Boston, MA, USA), was used. ...
... Not surprisingly, the intra-reliability was higher 86% (12 of 14 positions) for the positions with excellent or good intrareliability. The ICC of box placements for the midfoot region was low, similar to findings by Vidmar et al. [19] and Hellstrand et al. [20]. In this area, some individuals have a more pronounced lateral arch, the cavus feet, with less contact with the ground. ...
... One strength in the current study was that the observers were skilled and followed a structured protocol. The data that were analysed were collected in stable conditions at the same gait lab with the same regimen as when the study started [20]. The authors strongly recommend that clinicians who consider using the F-Scan® system should train the placement of the TAM boxes before in-shoe pressure measurements are used in clinical practice to evaluate the effects of pressure-reducing orthotics. ...
Background:
The provision of therapeutic footwear, to prevent the development of diabetic foot ulcers by re-distributing high peak plantar pressure is frequently prescribed for patients with diabetes. Areas of interest (ROI) are identified by placing boxes on the visualised pressure movie. The aims were to evaluate the inter-reliability of the placements of seven ROI boxes and to explore how the box placement affected peak pressure in the seven ROIs.
Methods:
Plantar pressure movies from 20 of a total of 40 movies were selected for the analysis. Boxes were placed at ROIs, the heel, the lateral midfoot, the metatarsal phalangeal heads (5, 3-4, 2 and 1) and the hallux. The box placements were registered for the left vertical position (L) and the top horizontal position (T) for each of the ROIs, based on registrations by two certified prosthetists and orthotists.
Findings:
The inter correlation coefficient of the placement of the boxes ranged from 1.00 to 0.12 (heel_L and metatarsal phalangeal head 2_L respectively). Of the 14 positions of the boxes; four were excellent, four were good, two were moderate and four were poor. No significant differences in the mean peak pressure corresponding to the box placements were found between the CPOs.
Interpretation:
The inter-reliability of eight of the 14 registered placements, made by prosthetists and orthotists, of the boxes in Scan® was good to excellent. A variation of 1.00-0.12 was present. Despite the variation, no significant differences in the corresponding mean peak pressure between prosthetists and orthotists was found.
