Graded stiffness offloading insoles better redistribute heel plantar pressure to protect the diabetic neuropathic foot.

BACKGROUND: Diabetic heel ulceration is a common, detrimental, and costly complication of diabetes. This study investigates a novel "graded-stiffness" offloading method, which consists of a heel support with increasing levels of stiffness materials to better redistribute plantar pressure for heel ulcer prevention and treatment. RESEARCH QUESTION: Is the novel "graded-stiffness" solution better able to redistribute heel pressure and reduce focal stress concentration areas of the heel? METHODS: Twenty healthy young men walked with four, 3D-printed, insole configurations. The configurations included the "graded-stiffness" insoles with and without an offloading hole under the heel tissue at risk for ulcerations and two conventional offloading supports of flat insoles with no offloading and simple holed offloading insoles. In-shoe plantar pressure was measured using the Pedar-X system. Peak pressure and pressure dose were measured at three heel regions: offloaded region, perimeter of offloaded region, and periphery region. RESULTS: The simple offloading configuration reduced pressure at the offloaded region; however, pressure at the perimeter of the offloading region significantly increased. With respect to ANOVA, the "graded-stiffness" offloading configurations were more effective than existing tested solutions in reducing and redistributing heel peak pressure and pressure dose, considering all heel regions. SIGNIFICANCE: The "graded-stiffness" offloading solution demonstrated a novel flexible and customized solution that can be manufactured on-demand through a precise selection of the graded-stiffness offloading location and material properties to fit the shape and size of the ulcer. This study is a follow-up in-vivo pilot study, in a healthy population group, to our previous computation modeling work that reported the efficiency of the "graded-stiffness" configuration, and which emphasizes its potential for streamlining and optimizing the prevention and treatment of diabetic heel ulcers.

A novel graded-stiffness footwear device for heel ulcer prevention and treatment: a finite element-based study.

Diabetic heel ulceration is a serious, destructive, and costly complication of diabetes. In this study, a novel "graded-stiffness" offloading method was proposed. This method consists of heel support with multi-increasing levels of stiffness materials, to prevent and treat heel ulcers. A three-dimensional finite element model of the heel was used to evaluate the novel "graded-stiffness" orthotic device compared to two existing solutions: (1) an insole with a hole under the active ulcer and (2) an insole with a hole filled with a soft material (elastic modulus of 15 kPa). Volumetric exposure evaluation of internal tissues to stress was performed at two volume-of-interests: (1) the area of the heel soft tissues typically at high risk for ulceration, and (2) the soft tissues surrounding the high-risk area. The models predict that the "graded-stiffness" offloading solution is more effective than existing solutions in distributing and reducing heel internal loads, considering both volume-of-interests. Comparing different material gradient combinations for the offloading support reveals considerable variation of the heel stress distribution. In clinical practice, the "graded-stiffness" technological solution enables to form an adaptable and flexible system that can be customized to a specific patient, through adequate selection of the offloading materials, to fit the shape and size of the ulcer. This solution can be made as an off-the-shelf product or alternatively, be manufactured by-demand using 3D printing tools. The proposed novel practical offloading solution has the potential for streamlining and optimizing the prevention and treatment of diabetic heel ulcers.

Finite element-based method for determining an optimal offloading design for treating and preventing heel ulcers.

Diabetic heel ulceration, a serious, destructive, and costly complication of diabetes, is often treated by custom-made offloading footwear. One common offloading device is a custom-made insole designed with a hole under the damaged site that is intended to reduce local mechanical loads on the ulcer. However, current devices do not take into account the increasing loads at the wound peripheries, and quantitative assessments and scientific guidelines for the optimal design of the offloading hole are lacking. Here, we develop a novel method to determine the volumetric exposure to mechanical loading of a human heel, at two volume of interests (VOIs) during walking in 150 different finite-element footwear configurations. We defined the two VOIs as (1) the area of the heel soft tissues typically at high risk of ulceration, and (2) the soft tissues surrounding the high risk area. For all model variants, three hole-geometry parameters were defined: (1) radius, (2) radius of curvature (ROC) and (3) depth. We found two combinations of the offloading parameters which minimize heel loads in both VOIs. The first is with a large offloading radius, large ROC and large depth, whereas the second is with a large offloading radius, large depth but relatively small ROC. Our novel practical scientific analysis method, that takes into account the ulcer site as well as the peripheral area, has the potential to optimize development of offloading solutions by streamlining the examination of their biomechanical efficiency, and thus may revolutionize prevention and treatment of diabetic ulcers at any foot location.

The effect of center of pressure alteration on the ground reaction force during gait: A statistical model.

BACKGROUND: Foot problems and lower-limb diseases (e.g., foot ulcers, osteoarthritis, etc.), are presented with a ground reaction force (GRF) that may deviate substantially from the normal. Thus, GRF manipulation is a key parameter when treating symptoms of these diseases. In the current study, we examined the impact of footwear-generated center of pressure (COP) manipulations on the GRF components, and the ability to predict this impact using statistical models. METHODS: A foot-worn biomechanical device which allows manual manipulation of the COP location was utilized. Twelve healthy young men underwent gait analysis with the device set to convey seven COP conditions: (1) a neutral condition, (2) lateral and (3) medial offset along the medio-lateral foot axis, (4) anterior and (5) posterior offset along the antero-posterior foot axis, and (6) a dorsi-flexion and (7) plantar-flexion condition. Changes in the magnitude and the early stance-phase impulse of the GRF components across COP conditions were observed. Linear models were used to describe relationships between COP conditions and GRF magnitude and impulse. RESULTS: With respect to ANOVA, the vertical and antero-posterior components of the GRF were significantly influenced by the COP configuration throughout the different stages of the stance-phase, whereas the medio-lateral components were not. The models of vertical, antero-posterior and medio-lateral GRF components were statistically significant. SIGNIFICANCE: The study results are valuable for the development of a method and means for efficient treatment of foot and lower-limb pathologies. The ability to predict and control the GRF components along three orthogonal axes, for a given COP location, provides a strong tool for efficient treatment of foot and lower-limb diseases and may also have relevant implications in sports shoe design. This study is a preliminary investigation for our ultimate goal to develop an effective treatment method by developing an autonomous GRF manipulations device based on closed-loop feedback.