CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Application Serial No. 63/217,338, having the title “OFFLOADING WALKING BOOT”, filed on July 1 , 2021 , the disclosure of which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] Diabetic foot ulcerations (DFUs), which often result in major amputations, are a serious healthcare issue exacting a significant social toll with respect to disability, morbidity and mortality, as well as economic burden. Often the single greatest barrier to healing these wounds is effectively offloading the ulcerated limb to alleviate the pressure and shear forces that cause DFUs.

SUMMARY

[0003] Embodiments of the present disclosure provide for offloading walking boots.

[0004] An embodiment of the present disclosure a modular offloading walker that includes a modular upper component and a modular lower component. The upper component can include a modular anterior component and a modular posterior component. The lower component includes a foot plate having a rocker sole and upright stays coupled to medial and lateral edges of the foot plate. The upright stays can have an adjustable height and the upper component can be removably attached to the upright stays.

[0005] Other compositions, apparatus, methods, features, and advantages will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional compositions, apparatus, methods, features and advantages be included within this description, be within the scope of the present disclosure, and be protected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Further aspects of the present disclosure will be more readily appreciated upon review of the detailed description of its various embodiments, described below, when taken in conjunction with the accompanying drawings.

[0007] Figures 1A-1C provide front perspective views of examples of a prototype device in accordance with embodiments of the present disclosure.

[0008] Figure 2 is a rear perspective view of an example of a prototype in accordance with embodiments of the present disclosure.

[0009] Figure 3 provides a schematic of an example foot bed for the device in accordance with embodiments of the present disclosure. [0010] Figure 4 is a Finite Elements Analysis (FEA) model of stress on portions of the walking boot.

[0011] Figures 5A-5C are perspective views of another example of a prototype in accordance with embodiments of the present disclosure.

[0012] Figures 6A-6B are camera images of an example of a prototype in accordance with embodiments of the present disclosure.

[0013] The drawings illustrate only example embodiments and are therefore not to be considered limiting of the scope described herein, as other equally effective embodiments are within the scope and spirit of this disclosure. The elements and features shown in the drawings are not necessarily drawn to scale, emphasis instead being placed upon clearly illustrating the principles of the embodiments. Additionally, certain dimensions may be exaggerated to help visually convey certain principles. In the drawings, similar reference numerals between figures designate like or corresponding, but not necessarily the same, elements.

DETAILED DESCRIPTION

[0014] Before the present disclosure is described in greater detail, it is to be understood that this disclosure is not limited to particular embodiments described, and as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0015] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0016] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure, the preferred methods and materials are now described.

[0017] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosure. Any recited method can be carried out in the order of events recited or in any other order that is logically possible.

[0018] Embodiments of the present disclosure will employ, unless otherwise indicated, techniques of biomedical science, material science, and the like, which are within the skill of the art.

[0019] The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to perform the methods and use the devices disclosed and claimed herein. Efforts have been made to ensure accuracy with respect to numbers (e.g., amounts, temperature, etc.), but some errors and deviations should be accounted for. Unless indicated otherwise, parts are parts by weight, temperature is in °C, and pressure is at or near atmospheric. Standard temperature and pressure are defined as 20 °C and 1 atmosphere.

[0020] Before the embodiments of the present disclosure are described in detail, it is to be understood that, unless otherwise indicated, the present disclosure is not limited to particular materials, manufacturing processes, or the like, as such can vary. It is also to be understood that the terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting. It is also possible in the present disclosure that steps can be executed in different sequence where this is logically possible. [0021] It must be noted that, as used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0022] As used herein, the following terms have the meanings ascribed to them unless specified otherwise. In this disclosure, "consisting essentially of" or "consists essentially" or the like, when applied to methods and compositions encompassed by the present disclosure refers to compositions like those disclosed herein, but which may contain additional structural groups, composition components or method steps (or analogs or derivatives thereof as discussed above). Such additional structural groups, composition components or method steps, etc., however, do not materially affect the basic and novel characteristic(s) of the compositions or methods, compared to those of the corresponding compositions or methods disclosed herein. "Consisting essentially of' or "consists essentially" or the like, when applied to methods and compositions encompassed by the present disclosure have the meaning ascribed in U.S. Patent law and the term is open-ended, allowing for the presence of more than that which is recited so long as basic or novel characteristics of that which is recited is not changed by the presence of more than that which is recited, but excludes prior art embodiments. [0023] In accordance with the purpose(s) of the present disclosure, as embodied and broadly described herein, embodiments of the present disclosure, in some aspects, relate to devices and systems for offloading foot strain in a wearer.

[0024] In general, embodiments of the present disclosure provide for devices for offloading foot stress in a wearer and methods of use thereof.

[0025] The present disclosure includes a modular offloading walker. The modular offloading walker can also be referred to as a boot. The walker can include an upper component and a modular lower component. The upper component can include two subcomponents, referred to as a modular anterior component and a modular posterior component. The lower component can include a foot plate having a rocker sole and upright stays coupled to medial and lateral edges of the foot plate. The upright stays can have an adjustable height. The upper component, or its individual sub-components, can be removably attached to the upright stays at variable heights.

[0026] The modular offloading walker, referred to herein as “the device”, can combine modular anterior and posterior brace parts in several sizes in order to provide an intimate fit to a wearer’s upper crural region of the leg, and can be coupled with a pre-fabricated frame to effectively offload the affected limb. Advantageously, the device can be used to offload strain on the foot for people having foot ulcerations associated with diabetes, people recovering from foot surgery, or experiencing other foot and/or ankle conditions that may benefit from reduced pressure on the foot.

[0027] Diabetes is a major health problem in the United States: 34.2 million people, or 10.5% of the US population, have diabetes. Another 88 million people aged 18 years or older have prediabetes (34.5% of the adult US population). ⁽¹⁾ A diabetic foot ulcer (DFU) is a significant complication of diabetes. The lifetime risk of developing a foot ulcer for someone with diabetes is 25%. ⁽²⁾ Every year, about 1-4% of people with diabetes develop a new foot ulcer. ⁽²⁾ A foot ulcer is the initial event in more than 85% of major amputations that are performed on people with diabetes. ⁽³⁾ In the United States, every year about 73,000 amputations of the lower limb not related to trauma are performed on people with diabetes. ⁽⁴⁾ Worldwide, every 30 seconds, a limb is lost to diabetes. Between 10-15% of DFUs do not heal. ⁽⁵⁾ Of DFUs that do not heal, 25% will require amputation. ⁽⁶⁾ In the United States, the cost to care for diabetic foot ulcers is about $11 billion per year.^

[0028] Successful diagnosis and treatment of patients with DFUs involves a holistic approach that includes optimal diabetes control, effective local wound care, infection control, restoring pulsatile blood flow and pressure relieving (offloading) strategies. A large number of DFUs are caused by pressure and shear forces on the plantar foot. Healing a pressure- related DFU is extremely difficult unless the DFU causing forces are mitigated. The gold standard for offloading is the total contact cast (TCC or iTCC). The strongest recommendation from the International Working Group on the Diabetic Foot with the highest quality of evidence is to offload with a non-removable, knee-high device with an appropriate foot-device interface, such as a total contact sole or tested interface device such as a pixelated innersole. ⁽⁸⁾ The total contact cast is applied in an intimately conforming manner with minimal padding to produce a “cone effect” and reduce plantar pressure by transferring weight-bearing pressure to the leg. It has the ability to reduce plantar pressures, restrict ankle motion, shorten stride length, reduce shear, and force adherence. It is significantly different than an orthopedic cast that is primarily designed to immobilize and is applied in a well-padded manner.

[0029] TCCs are touted as the gold standard, but in actual practice are not used as such/ ⁹ ’ ¹⁰⁾ An analysis of data from the wound registry found that only 6% of patients with a DFU received treatment with a TCC. ⁽⁹⁾ Another study surveyed 895 clinics and concluded that only 1.7% of centers routinely use TCCs. ⁽¹⁰⁾ Shoe-based systems were used most of the time in the place of TCCs. Reported drawbacks to TCCs include patient tolerance complaints (55.3%), clinic application time (54.3%), cost of materials (31.6%), reimbursement issues (27.5%), lack of familiarity with the TCC (25%), and clinician coverage (10.6%). ⁽¹⁰⁾

[0030] Additionally, TCC application requires specific, specialized materials. Each TCC requires a length of stockinette, specially cut 'A” felt to pad the anterior tibial, dorsal foot and malleolar areas, roll cast padding for additional padding around the top of the TCC and ankle area, 14” adhesive backed foam to cover toes, 1 plaster and 4 fiberglass rolls, a solid foot plate and a rubber walking surface (a cast boot can be used in place of the foot plate and rubber walking surface). The technique of application is very specialized as is the removal. In many instances, a 9-week course of treatment with a TCC kit can cost more than $2800, though many wounds take significantly longer to heal.

[0031] Other existing devices for DFUs include braces that do not include adjustable upper components, or include a narrow and/or unstable base for the foot portion. Some existing devices also include thick bases which cause a large discrepancy in limb length between the casted leg and the free leg, which can cause balance and stability issues for the wearer. While the limb length discrepancy may not be a serious difficulty for an able-bodied person or an athlete with an injury, compensating for uneven limbs can be problematic for a person with a DFU and associated health concerns.

[0032] Multiple walking casts are presently available but none of these devices effectively offload. Rather, they restrict the propulsive phase of gait, which slows the patient down to assist in healing, but it is not true offloading. The pixelated foam inserts in the foot portion of a walking cast can crush quickly under the forces an obese patient, which quickly limits their efficacy. The rigidity of the walking cast boots often pose a problem for a typical diabetic patient due to poor fit. Walking casts are not designed to accommodate a deformed foot/ankle such as is often seen in a patient having charcot neuroarthropathy. The neuropathic diabetic patient does not feel pressure from the walking boot and suffers further injury from the intended cure.

[0033] The modular offloading walker described herein can address many of the shortcomings of existing treatments, as discussed above.

[0034] The present disclosure provides for a modular offloading walker having a customizable, adjustable upper component. The upper component can include an anterior and posterior component.

[0035] The anterior and posterior components can be modular to adjust to the particular needs of the wearer. In some embodiments, the anterior and posterior components can be provided in multiple sizes to fit wearers of various sizes. For example, 2, 3, 4, 5, or 6 different sizes of each component may be available to accommodate anatomical variability and wearer size.

[0036] In some embodiments, the anterior component can be provided in a left or right side. The anterior part allows for loading of the anterior medial tibial area of the leg and thus would be asymmetric to fit a left or a right leg. The asymmetrical shape provides protection for and prevents pressure over the area of the peroneal nerve. The energy that would normally be absorbed by the plantar surface of the foot is instead offloaded through the device such that the bulk the force is spread between the device and the wearer’s crural portion of the leg. The sided, sized fit ensures that the load is transferred to the area just inferior to the patella.

[0037] The posterior component can also be provided in multiple sizes. For example, 2, 3, 4, 5, 6, or 7 different sizes may be available to accommodate anatomical variability and wearer size. The posterior component can be fitted to either leg.

[0038] In some embodiments, one or both of the anterior and posterior components can be custom-made for a wearer, such as through volumetric scanning. A customized orthotic such as the upper component of the device can provide an intimate fit, providing a dispersal of forces across a greater area of the leg, and mitigating risk of injury to the upper leg. The customized components only need to be made once, unlike a cast. Advantageously, because the device is removably secured to the wearer, it does not need to be removed with a cast cutter and infection can be mitigated. As the modular walker can be removed simply and without expertise, it is not contraindicated for use to treat an infected ulcer as monitoring of the site can be performed. When compared to a cast, application and removal time are reduced, thereby reducing the time the patient is in a treatment area and increasing provided productivity. [0039] The lower component, or foot portion, can also be provided in multiple sizes to accommodate wearer foot size (e.g. small - extra-large, by shoe size, and/or in wide widths). In a particular embodiment, the lower component can be provided in such as small, medium, large, and extra-large. The lower component can include a foot plate having a rocker sole, wherein the foot plate is attached to two upright support struts, also referred to as stays. In some embodiments, the rocker sole and the upright stays can be manufactured in a single piece. In some embodiments, the lower component can be made from acetal homopolymer, aluminum, or other suitable materials having appropriate mechanical strength and weight, as can be appreciated by one of ordinary skill in the art. The foot plate can form a wide, stable base. In a particular example, the foot plate can be about 3.5 inches to 6 inches wide or about 5 inches wide. The total height of the foot plate can be about 1 inch to about 1.5 inches high. The width and height of the foot plate are similar to a normal shoe such that the wearer’s normal stride is impacted as little as possible to prevent injury.

[0040] In some embodiments, the patient’s foot can be covered and secured within a soft “bootie” or slipper construct. The bootie can be made of fabric, foam, or a combination thereof. The bootie can attach to the medial and lateral stays of the lower component via fasteners (e.g., hook and loop attachments to “D” rings or other fasteners) in order to gently secure the foot and ankle.

[0041] In some embodiments, all or part of the device may be injection molded. In some embodiments, the anterior and posterior components can be injection molded. In other embodiments, all or part of the device may be 3D printed. In some embodiments, the all or part of the device (e.g. the anterior and/or posterior components) may be made from polyvinylchloride, acetal homopolymer (also called Delrin or Polyoxymethylene (POM)), or other suitable materials having appropriate mechanical strength as can be appreciated by one of ordinary skill in the art.

[0042] The upper component can be removably attached to the stays of the lower component. Both the anterior component and the posterior component are modular, such that they can be removably attached or adjusted independently of one another if needed. The anterior and/or posterior component can have a receiving slot or loop on the external surface to receive the stays, such that the stays are prevented from being in contact with the wearer’s skin. The anterior and posterior components provide cushion and protection from the stays. In some embodiments, the upper component can be fitted over the stays and locked in place at a particular height appropriate to the wearer. The upper component can be coupled to the stays with such as a locking bolt. The bolt can be tightened with such as an alien key. Other locking mechanisms such as push-button locks, butterfly nuts, linear ratchet, and the like may be used. In some embodiments, the stays can include holes at intervals to accept the locking mechanism. Advantageously, the adjustable height ensures that the load is provided to the wearer at the intended anatomical location, no matter the lower leg length of the wearer. In some embodiments, the stays can be made of a metal, metal alloy, or can be made of other materials suitable for providing support (e.g., injection molded plastics). [0043] In some embodiments, the stays can be horizontally adjusted such that the distance between the stays can accommodate a variety of calf widths.

[0044] The anterior and posterior components can be tightened together, such as tightened around the wearer’s leg, using straps having hook and loop fasteners or cam locking straps similar to a ski boot.

[0045] The foot portion can include a padded base (e.g., a foot pad) on the superior surface to receive the sole of the wearer’s foot. In some embodiments, the padded base can be made from ethylene-vinyl acetate (EVA) foam or similar. In some embodiments, the padded base can include areas or “zones” that have cutouts, such that cutout areas can optionally be removed in an area corresponding to an ulcerated area of the wearer’s foot to further offload the area of ulceration. The cutout areas can include such as five rectangular areas for the metatarsal heads, two areas for the fifth metatarsal/cuboid/navicular and two areas in the heel.

[0046] In some embodiments, the device can be part of a system that includes a sleeve (e.g., a silicone-lined sleeve) to protect the skin and tissue of the upper leg the wearer. This can be similar to the silicone-lined sleeves used be wearers of below-knee prosthetics. In other embodiments the anterior and posterior components can include a comfort material forming a lining and/or pad that both protects the skin and increases the device grip on the leg. The comfort material can be such as silicone, foam, or natural fibers.

[0047] In some embodiments, a locking or anti-tamper device can be included to ensure device stays in place and is not removed by the wearer.

[0048] The device described herein is adjustable such that the upper component sits at a height from the foot portion that is specific to the wearer. This ensures that anterior and posterior components of the device and the upper crural portion of the leg bear the wearer’s weight and offload a large portion of pressure from the foot, rather than the load being on the plantar aspect of the foot. When a patient wears a commercially available cam walker or walking boot, the foot loads completely on the sole of the device. Most healing benefits in current devices, if any at all, come from the restrictive nature of the cast. The modular, calfweight bearing device described herein can significantly reduce pressure, thus mitigating or eliminating the cause of 90% of diabetic foot ulcers and promoting more rapid healing.

[0049] In some embodiments, the device can have a total weight of about 3 pounds to about seven pounds, or about 3.5 pounds.

[0050] Advantageously, the device described herein functions similarly to a total contact cast but does not require the same level of specialized skills to apply and remove it. Additionally, the devices would not be contra-indicated with infection as monitoring of the wound can still occur.

[0051] Turning now to the figures, Figure 1A shows a front perspective view of an example offloading walking boot 100. Upper component 104 includes anterior component 102, which is fitted to the upper crural area of a wearer’s leg 10. Anterior component 102 is, in the shown embodiment, fitted to the contours of a right leg, similar to a sports shin guard. A left side option would be used for a left leg. Anterior component 102 can be strapped snugly to the leg 10 and to posterior component 110 (not visible in this view) by straps 108 and 109. In the shown embodiment, the strap is secured in position by a buckle.

[0052] Upper component 104 is secured to lower component 130 by slotting stays 136 through slots 106 on the anterior component 102 and slot 114 on the posterior component 110. Stays 136 have an adjustable height and can be locked into place (not shown).

[0053] Lower component 130 includes a foot plate 132, which includes a rocker sole 134. The foot plate 132 includes a foot pad 138 on the superior surface to cushion the plantar surface of the wearer’s foot.

[0054] Figure 1B provides a view with modified straps and slotting stays. Figure 1C shows the offloading walking boot 100 without the upper component attached.

[0055] Figure 2 is a rear perspective view of the offloading walking boot device 100 shown in Figure 1. Posterior component 110 includes loops 112 and 113 through which straps 108 and 109 can pass to secure components 102 and 110 to each other and the wearer’s leg 10. Slot 114 secures the posterior component 110 to the stays 136.

[0056] Figure 3 is a drawing of the superior side of the foot pad 338. The foot pad 338 can be made of a foam or other supportive material, and can include perforated areas that can be punched out to further relieve pressure at a wound site and allow the wound to “float”. Although the perforated areas are shown as rounded rectangles, other shapes, sizes, numbers, and configurations of the perforated areas can be envisioned by one of ordinary skill in the art. In some embodiments, the area that is removed may span the full depth of the foot pad so that a hole is formed, or the removed area may be shallower than the foot pad such that a thin layer of cushion remains below the wound.

[0057] Figure 4 demonstrates that the stays 136 are load-bearing elements and that the foot portion 132 receives little to no load, as shown via Finite Element Analysis.

[0058] Figures 5A and 5B are perspective views of an offloading boot 100 in which the stays 136 have holes at intervals to receive fasteners in slots 106 and 114. Anterior component 102 and posterior component 110 can be moved to adjust to the wearer, and then the fasteners 106a and 114a can be locked into the holes on stays 136. Straps 108 and 109 are not shown. Figure 5C shows a realistic rendering of the offloading boot 100. [0059] Figures 6A and 6B are photographs of one embodiment of the offloading walking boot 100 that includes stays 138 having adjustment holes to receive fasteners 106a and 114a as described above. Straps 108 and 109 are not shown. Although stays 138 are shown as upright bars with squared edges and corners, the stays could have different shapes, such as rounded edges and/or rounded corners or a more contoured shape to ensure comfort to the wearer while providing the strength and stability needed. While the stays 138 are depicted as bolted to the foot plate, the foot plate and stays could be integrally manufactured, as can be envisioned by one of ordinary skill in the art.

[0060] In another embodiment (not shown), the stays can have a curved upper portion that provides support to the patella.

[0061] It should be noted that ratios, concentrations, amounts, and other numerical data may be expressed herein in a range format. It is to be understood that such a range format is used for convenience and brevity, and thus, should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. To illustrate, a concentration range of “about 0.1% to about 5%” should be interpreted to include not only the explicitly recited concentration of about 0.1 wt% to about 5 wt%, but also include individual concentrations (e.g., 1%, 2%, 3%, and 4%) and the sub-ranges (e.g., 0.5%, 1.1%, 2.2%, 3.3%, and 4.4%) within the indicated range. In an embodiment, “about 0” can refer to 0, 0.001 , 0.01 , or 0.1. In an embodiment, the term “about” can include traditional rounding according to significant figures of the numerical value. In addition, the phrase “about ‘x’ to ‘y’” includes “about ‘x’ to about ‘y’”.

Aspects of the Disclosure

[0062] The present disclosure will be better understood upon reading the following numbered aspects, which should not be confused with the claims. Any of the numbered aspects below can, in some instances, be combined with aspects described elsewhere in this disclosure and such combinations are intended to form part of the disclosure.

[0063] Aspect 1. A modular offloading walker, the walker comprising a modular upper component and a modular lower component, wherein the upper component comprises a modular anterior component and a modular posterior component; wherein the lower component comprises a foot plate having a rocker sole and upright stays coupled to medial and lateral edges of the foot plate; wherein the upright stays have an adjustable height; and wherein the upper component is removably attached to the upright stays.

[0064] Aspect 2. The modular offloading walker according to aspect 1 , wherein the modular anterior component is shaped to fit a left side or a right side. [0065] Aspect 3. The modular offloading walker according to any of the preceding aspects, wherein each of the modular anterior component and the modular lower component are provided in a size specific to a wearer.

[0066] Aspect 4. The modular offloading walker according to any of the preceding aspects, further comprising a foot pad on a superior surface of the foot plate.

[0067] Aspect 5. The modular offloading walker according to any of the preceding aspects, wherein the foot pad contains removable areas corresponding to regions of a wearer’s foot, such that the removed areas lessen the pressure on a lesion or sensitive area on the wearer’s foot.

[0068] Aspect 6. The modular offloading walker according to any of the preceding aspects, wherein one or both of the anterior component and the posterior component is custom made for a wearer.

[0069] Aspect 7. The modular offloading walker according to any of the preceding aspects, wherein one or both of the anterior component and the posterior component comprises polyvinylchloride, acetal homopolymer, or a combination thereof.

[0070] Aspect 8. The modular offloading walker according to any of the preceding aspects, wherein one or both of the anterior component and the posterior component is lined with a comfort material.

[0071] Aspect 9. The modular offloading walker according to any of the preceding aspects, wherein one or both of the anterior component and the posterior component are removably attached to the upright stays via a receiving slot on the component.

[0072] Aspect 10. The modular offloading walker according to any of the preceding aspects, further comprising straps that tighten the anterior component and the posterior component to the wearer’s leg.

[0073] Aspect 11. The modular offloading walker according to any of the preceding aspects, wherein the walker offloads force from a wearer’s foot such that the force is received by an upper crural portion of the wearer’s leg and the anterior and posterior components of the walker.

[0074] Aspect 12. The modular offloading walker according to any of the preceding aspects, wherein the foot plate has a width of about 3.5 inches to 6 inches wide and a height of about 1 inch to about 1.5 inches high.

[0075] It should be emphasized that the above-described embodiments of the present disclosure are merely possible examples of implementations, and are set forth only for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiments of the disclosure without departing substantially from the spirit and principles of the disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure. References:

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3. Brownrigg, J.R.W., Apelqvist, J., Bakker, K., Schaper, N.C., and Hinchliffe, R.J., Evidence-based managed of PAD & the Diabetic Foot. Euro J Vase and Endovasular Surg, 2013. 45(6): p. 673-681.

4. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014, Atlanta, GA: US Department of Health and Human Services; 2014.

5. Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet 2005;366:1719-1724pmid:16291066

6. Pemayun, T.G.D., Naibaho, R.M., Novitasari, D., Amin, N., Minuljo, T.T., Risk factors for lower extremity amputation in patients with diabetic foot ulcers: a hospital-based casecontrol study. Diabetic Foot & Ankle, 2015. 6:10.3402/dfa.v6.29629. doi:10.3402/dfa.v6.29629.

7. Verrone Quilici, M.T., de Sa Del Fiol, F., Franzin Vieira, A.E., Toledo, M.A., Risk Factors for Foot Amputation in Patients Hospitalized for Diabetic Foot Infection. J Diabetes Research; 2016, Article ID 8931508, 8 pages, 2016.

8. International Working Group on the Diabetic Foot. IWGDF Guidance on Footwear and Offloading Interventions to Prevent and Heal Foot Ulcers in Patients With Diabetes. http://www.iwgdf.org/files/2015/website_footwearoffloading.p df

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10. Wu SC, Jensen JL, Weber AK, Robinson DE, Armstrong DG. Use of pressure offloading devices in diabetic foot ulcers: do we practice what we preach? Diabetes Care.

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