AU2012261588B2 - Insole - Google Patents

Abstract

- 21 Abstract An insole, the insole defining a forward region, a rearward region, and a mid region, the mid region further including a lateral region including an outer edge and a low arch region including an outer edge, the insole comprising: 5 (i) a first part including an upper surface for contacting the sole of a foot, when in use, and a lower surface including a recessed portion; and (ii) a second part, adapted to be received in the recessed portion, for reinforcing or stabilising the forefoot and midfoot region of the foot. r-i) (NJi

Description

2012261588 24 Jan 2017 -1 -Insole

The present invention relates to an insole for footwear.

Background to the Invention

Insoles are often used as orthotic devices to support, align, prevent, or correct 5 deformities or to improve the function of the foot, lower limb, pelvis and spine.

During gait, the foot moves through a range of motions including pronation and supination whilst passing the foot’s neutral position.

The majority of orthotic devices for feet currently on the market have in-built control to reduce the pronatory movement of the foot. This is because the belief ίο is majority of the population are pronated (i.e. rolling in or “flat footed”). However, a large amount of presenting cases having a “neutral” or “supinated” foot type. Thus all the medial/arch-controlling or “anti-pronatory” devices are rendered useless and even dangerous for these patients. In many cases, the use of “anti-pronatory” or “medial/arch-control” devices in patients that have a “supinated” or 15 “neutral” foot-type, may cause injury, increase the severity of their presenting/initial symptoms or develop new complaints.

The present invention seeks to address or at least partially alleviate problems with prior art orthotic devices.

Summary of the Invention 20 According to the present invention, there is provided an insole consisting essentially of two parts and defining a forward region, a rearward region, and a mid region, the mid region further including a lateral region including an outer edge and a low arch region including an outer edge, the insole comprising: (i) a first part consisting of a unitary member with a hardness of at least 40A 25 including an upper surface for contacting the sole of a foot, when in use, 2012261588 24 Jan 2017 -2- and a lower surface including a recessed portion and a projection that extends away from the upper surface and from the rearward region to the mid region; and (ii) a second part, adapted to be received in the recessed portion, for 5 reinforcing or stabilising the forefoot and midfoot region of the foot and including an elongate stabilising member located forward of the low arch region and extending transversely between the outer edge of the lateral region and the outer edge of the low arch region for supporting the metatarsals of a user, said second part further comprising an aperture ίο adapted to receive the projection.

For the purposes of the present invention the term “insole” includes a member built into or forming an integral member of footwear such as an insole board, or as a separate element, including, e.g. a liner or removable insole. “Insole” also includes after-market insole devices and custom or prefabricated foot orthotics, 15 which may be inserted into a footwear product post-manufacture. “Insole” also includes blanks that can be customized to suit individual requirements. Insoles of the present invention may also be cut into or formed in the foot supporting surface of a shoe.

For the purposes of the present invention the term “low arch region” refers to a 20 region that defines a neutral arch height that can be used to treat both supinated and pronated foot types. Preferably, the low arch region is adapted to provide relatively low levels of arch control. Preferably, the low arch region has a maximum height or thickness of 15-30mm, more preferably, 15-25mm or 15- 20mm such as 19mm. The provision of a low arch region of the present 25 invention conforms with the natural biomechanics of the foot to assist in the increased comfort and wearability of the device and also has a number of advantages including one or more of: « it can reduce the bulk of the insole; » it can have less impact on the natural biomechanics of the foot; providing 2012261588 24 Jan 2017 -3- a natural base for the practitioner to apply corrective control. * it can result in less wear and distortion of the lateral aspect of the insole and the footwear in which it is used.

Preferably, the insole is neutral in that it is adapted to be customized to suit the 5 needs of a particular user. In this regard, the present invention has the advantage that it provides a basis for the practitioner to apply the required control, specific to the patients needs. This enables the practitioner to customise a prefabricated supportive insole immediately in the practice, therefore, allowing for effective and immediate treatment. ίο The insole of the present invention may also be adapted to enable practitioners to be able to cut to fit a patient’s shoes and be able to provide the required degree of control to treat their condition(s). Preferably, the insole of the present invention is adapted to allow its length, width and shape to be adjusted using scissors. This allows a practitioner to cut the insole specifically to fit the patient’s 15 shoes during the consult, allowing for customisation and increasing compliance in the patient wearing the device. This also allows for 3 main lengths and types of devices (i.e. 3Λ, sulcus and full lengths), allowing the patient to be able to fit the orthotic device in a variety of different shoes.

The insole of the present invention is particularly suitable for use with slimmer 20 and shallow footwear on the market such as women’s fashion shoes including high heeled shoes, men’s dress shoes and narrow-fitting sports boots and casual shoes.

The first part may be made of a first material and the second part may be made of a second material. In this regard, the second part can ensure the insole 25 provides reinforcement and support but at the same time allowing for a reduced bulk of the insole, compared to a one part insole, thus allowing it to be slimmer and yet extremely functional.

Preferably, the first and second materials are different materials. When the first 2012261588 24 Jan 2017 -4- and second parts are made of different materials it is preferred for the second part to be made of harder material than the first part.

Preferably, the first material has a hardness of 20A-95A, 40A-90A, 50A-95A, 50A-90A, 60A-90A or 70A-80A (where “A” refers to the Shore-A Scale). 5 Preferably, the first material is ethylene vinyl acetate (EVA), polyurethane (PU) or polyvinyl chloride (PVC) PP (polypropylene) or PE (polyethylene).

Preferably, the second material has a hardness of between 40-95A, 40A-90A, 50A-95A, 50A-90A, 60A-90A or 70A-80A (where “A” refers to the Shore-A Scale). Preferably, the second material has flexibility but no compression and very ίο minimal deformation properties.

Preferably, the second part is made of a thermoplastic polyurethane (TPU) material, TPR (thermoplastic rubber), PVC or EVA

Preferably, the upper surface of the first part forms at least part of the low arch region of the insole. In this regard, the upper surface of the first part may further 15 comprise a first arch portion formed by contouring the upper surface upwards to provide a curved, inclined surface to the main plane of the upper surface for engaging and supporting the foot arch of the user.

The height of the first arch portion is dependent on the height of the low arch region of the insole and cannot exceed the height of the low arch region of the 20 insole. Preferably, the first arch portion has a maximum height or thickness of 15-30mm, more preferably, 15-25mm or 15-20mm such as 19mm.

Preferably, the upper surface of the first part comprises a raised portion located so that in use it is positioned to support the metatarsal portion of a user’s foot.

Preferably the upper surface of the first part also includes a contoured perimeter 25 edge formed by contouring the upper surface upwards towards its perimeter edge to provide a curved, inclined surface to the main plane of the upper surface 2012261588 24 Jan 2017 -5- at the edge. The contoured perimeter edge may extend around one or more parts of the perimeter. Preferably the height of the contoured perimeter edge is higher at the part of the first part that is positioned in the rearward region of the insole that receives the heel of the user’s foot, relative to the part of the first part 5 that is positioned in the forward region of the insole.

The first part may further comprise at least one region delineated thereon for receiving an additional bolster member for raising the insole at a predetermined location. These regions are intended to assist with the placement of the bolster member(s) during the process of customizing the insole to suit a particular user, ίο Preferably, the region delineated on the first part is on its lower surface.

The first part may further comprise at least one marking delineated thereon identifying where the part may be altered, such as by cutting, to alter its length, width and/or shape. These changes allow a practitioner to cut the insole specifically to fit the patient’s shoes, allowing for customisation and increasing 15 compliance in the patient wearing the device. Preferably, the at least one marking includes a mark indicating one or more lengths such as %, sulcus and full length Preferably, the at least one marking delineated on the first part is on its lower surface.

The shape and location of the recessed portion of the first part may be varied 20 provided it is adapted to receive the second part that is discussed hereunder. In this regard, because the first and second parts are designed to fit together, the shape and location of the recessed portion will depend on the shape and location of the second part that is described hereunder.

Preferably, the recessed portion defines a transverse portion that extends at least 25 partially and preferably entirely between the parts of the first part that correspond to the outer edge of the lateral region and the outer edge of the low arch region. Preferably, the transverse portion is elongate in shape such as a bar member or the like. 2012261588 24 Jan 2017 -6-

The recessed portion may also define a lip portion that is positioned so as to abut the outside upper edge of the second part when it is positioned in the recessed portion. Preferably the lip portion extends around the entire perimeter of the recessed portion. Alternatively, is may extend only around the perimeter of the 5 recessed portion corresponding to the rearward, lateral and low arch regions.

Preferably, the recessed portion defines a concave portion shaped and positioned to abut the second arch portion of the second part that is described hereunder. Preferably, the concave portion is shaped to be compatible and receive the second arch portion in a substantially flush fit arrangement. ίο Preferably, the recessed portion defines a raised portion shaped and positioned to be received, such as in a friction fit, in a compatible aperture in the second part that is described hereunder. The shape and arrangement of the recessed portion may be varied provided it is compatible with the aperture in the second part.

Preferably, the second part includes an upper surface for contacting the lower 15 surface of the first part and a lower surface. Even more preferably the upper surface of the second part is textured to improve its bonding with the first part. In this regard, a textured surface is able to form a stronger bond with the first part and hence reduce the likelihood of movement between the parts post-assembly.

Preferably the second part extends from the rearward region and into the mid 20 region of the insole.

Preferably, the upper surface of the second part forms at least part of the low arch region of the insole. In this regard, the upper surface of the second part may further comprise a second arch portion formed by contouring the upper surface upwards to provide a curved, inclined surface to the main plane of the 25 upper surface for supporting the foot arch of the user.

The second arch portion may be shaped and positioned to fit into the concave portion of the recessed portion of the first part. 2012261588 24 Jan 2017 - 7-

Preferably, the height of the second arch portion is dependent on the height of the low arch region of the insole. Preferably, the height of the second arch portion is less than the height of the first arch portion of the first part. In this regard, the second arch portion may have a maximum height or thickness of 15-5 30mm, more preferably, 15-25mm or 15-20mm such as 19mm, noting that the height or thickness of the second arch portion will be less than the height/thickness of the insole and/or the first arch portion.

Preferably, the second part includes a stabilising member located forward of the low arch region and extending transversely, at least partially and preferably ίο entirely, between the parts of the second part that correspond to the outer edge of the lateral region and the outer edge of the low arch region. The stabilising member is shaped and configured to fit within the transverse portion of the recessed portion of the first part crossing the metatarsals. Preferably, the stabilising member is elongate in shape such as a bar member or the like. 15 The stabilising member assists and reinforces the support and stability of the insole in the forefoot and midfoot areas. The forefoot area of the foot encounters significant increased loading during the propulsion phase of the gait cycle. The stabilising member can also assist in increasing the life and wear of the insole.

Preferably, the second part includes a heel supporting member located in the 20 rearward region. The heel supporting member may comprise a generally “IT shaped member, shaped to support the heel in a wrap around fashion, with the upright members of the “U” extending up both sides of the rearward region and the curved part of the “U” extending around the heel in the rearward region.

At least two of, and preferably all three of, the second arch portion, the stabilising 25 member and the heel supporting member may be provided as a unitary member. When the second arch portion, the stabilising member and the heel supporting member are provided as a unitary member, the unitary member may comprise a “U” shaped member including the second arch portion and the heel supporting 2012261588 24 Jan 2017 - 8- member and the U shape being closed by a cross member extending between the upright members of the “IT, the cross member being the stabilising member.

Preferably, the lower surface of the second part includes an aperture shaped and configured to fit, preferably a friction fit, with the raised portion of the first part. 5 General

Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. The invention includes all such variation and modifications. The invention also includes all of the steps and features referred to or indicated in the ίο specification, individually or collectively and any and all combinations or any two or more of the steps or features.

Each document, reference, patent application or patent cited in this text is expressly incorporated herein in their entirety by reference, which means that it should be read and considered by the reader as part of this text. That the is document, reference, patent application or patent cited in this text is not repeated in this text is merely for reasons of conciseness. None of the cited material or the information contained in that material should, however be understood to be common general knowledge.

The present invention is not to be limited in scope by any of the specific 20 embodiments described herein. These embodiments are intended for the purpose of exemplification only. Functionally equivalent products and methods are clearly within the scope of the invention as described herein.

The invention described herein may include one or more range of values (e.g. size etc). A range of values will be understood to include all values within the 25 range, including the values defining the range, and values adjacent to the range which lead to the same or substantially the same outcome as the values immediately adjacent to that value which defines the boundary to the range. 2012261588 24 Jan 2017 -9-

Throughout this specification, unless the context requires otherwise, the word "comprise" or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers. 5 Other definitions for selected terms used herein may be found within the detailed description of the invention and apply throughout. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the invention belongs.

The present invention now will be described more fully hereinafter with reference ίο to the Drawings, in which certain preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to any of the embodiments set forth herein; rather, the embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the 15 art.

Brief Description of Drawings

Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figures 1, 2, 3, 4 and 5 are perspective views of an insole according to one 20 embodiment of the present invention;

Figure 6 is an underside view of the insole of Figures 1 to 5;

Figure 7 is a plan view of the first part of the insole of Figures 1 to 5;

Figure 8 is a rear view of the insole of Figures 1 to 5 in the direction of A in Figure 6; 25 Figure 9 is a front view of the first part of the insole of Figures 1 to 5 in the 2012261588 24 Jan 2017 - 10- direction of B in Figure 7;

Figure 10 is a perspective view of the first part of the insole of Figures 1 to 5;

Figures 11A and 11B are perspective views of the second part of the insole of Figures 1 to 5; 5 Figure 12 is a cross-sectional view along the line D-D’ of Figure 9;

Figure 13 is a side view of the insole of Figures 1 to 5 in the direction of C in Figure 7;

Figure 14 is a longitudinal cross-sectional view of the insole of Figure 13;

Figures 15 to 17 are views of a pair of insoles according to the embodiment of ίο the invention depicted in Figures 1-5;

Figure 18 is a schematic diagram of the underside of the insole of Figures 1 to 5 showing the locations of the positional guides and other markings for customizing the insole to suit particular users; and

Figure 19 is a simplified schematic representation of an insole showing the 15 various regions referred to herein.

Detailed Description of Embodiments of the Invention

Figure 19 depicts a simplified schematic of an insole showing various regions discussed herein with reference to the present invention. The simplified insole generally indicated by the numeral 100 includes a forward region (in use, located 20 under the forefoot) 102, a mid region (in use, located under the midfoot) 104 and a rearward region (in use, located under the rearfoot) 106. The mid region 104 includes an arch region 108 and a lateral region (in use, located under the medial region) 110. The above regions, when an insole is in use, have the following general purposes/functions. The rearward region 106, underlies the wearer’s 25 heel, the arch region 108 underlies the wearers foot arch towards the instep, the 2012261588 24 Jan 2017 - 11 - lateral region 110 underlies the outside of the wearers foot adjacent the wearers foot arch and the forward region 102 underlies the ball and toes of the wearers foot.

The insole 1 according to one preferred embodiment of the present invention is 5 shaped to be inserted into, and to fit within, a shoe or other suitable footwear and defines a forward region, a mid region (including an arch and a lateral region) and a rearward region. The insole 1 has an upper surface 4, defined by the upper surface of the first part 2, upon which the sole of a foot will rest, covering all the regions in Figure 19 and a lower surface 11, defined by the lower surfaces ίο of the first and second parts 2, 3. The upper surface 4 of the insole 1 also includes a heel cup 5, located in the rearward region, an elevated portion 6, located in the mid region, for supporting the metatarsal portion of a patient’s foot, and a forward region 7 for supporting the ball and toes of a patient’s foot.

An insole 1 according to one embodiment of the invention is a composite two-part 15 insole which comprises a first part 2 and a second part 3 which are fitted together and cooperate.

The insole 1 is shaped to be inserted into, and to fit within, a shoe or other suitable footwear and defines a forward region, a mid region (including an arch region and a lateral region) and a rearward region (see Figure 19). The insole 1 20 has an upper surface 4, defined by the upper surface of the first part 2, upon which the sole of a foot will rest, covering all the regions in Figure 19 and a lower surface 11, defined by the lower surfaces of the first and second parts 2, 3. The upper surface 4 of the insole 1 also includes a heel cup 5, located in the rearward region and having a height of 9mm to 15mm but preferably 11mm, an elevated 25 portion 6, located in the mid region, for supporting the metatarsal portion of a patient’s foot, and a forward region 7 for supporting the ball and toes of a wearer’s foot. The insole 1 includes a low arch region in the form of low arch support 8 which is formed by contouring and shaping of the first part 2 and second part 3. The low arch support 8, at its highest point is 19mm. 2012261588 24 Jan 2017 - 12-

The first part 2 comprises the major part of the insole 1, while the second part 3 is arranged to be received into a recessed portion 10 of the lower surface of the first part 2 as will be described in further detail below.

The upper surface 4 of the first part 2 is contoured to engage/contact the plantar 5 surface of the foot of the user. The upper surface 4 includes a contoured perimeter edge in the form of raised edge 9 that runs around the sides and heel portion 5 of the first part 1 to assist in retaining the wearer’s foot in place.

The first part 2 is further contoured to form the heel cup 5, which is also defined by the raised edge 9 at the rear of the insole 1. The heel cup 5 has a low heel ίο cup height/depth of 9mm to 15mm but preferably 11 mm.

The first part 2 is also contoured to form an elevated portion 6, located in the mid region and extending towards the forward region, to support the metatarsal and the forefoot. A first arch portion in the form of arch support portion 8’ of the first part 2 forms 15 part of the low arch support 8 and is formed as part of the raised edge 9. It is located in the arch region of the mid region along a portion of one side 12 of the first part 2 to underlie a patient’s foot arch. The arch support portion 8’ is formed by curving the upper surface 4 upwards to provide a curved, inclined surface 13 to the main plane of the upper surface 4: it being contoured to engage and 20 support the foot arch of the user. The low arch support 8 is of a relatively low height of approximately 19mm.

The lower surface 14 and the outside of the raised edge 9 of the first part 2 has a recess or cut away region 10 at the mid and rearward regions, and which is shaped and dimensioned to receive the second part 3, so that, when the second 25 part 3 is received therein, the first and second parts 2, 3 form the composite insole 1.

The lower surface 14 has a number of regions delineated thereon for receiving 2012261588 24 Jan 2017 - 13- an additional bolster member in the form of positional guides 200, 202, 204 imprinted thereon to assist practitioners in the application of control required for the patient. The positional guides delineate areas where the practitioner places additional elements to customise the orthotic insole 1 to suit the wearer. These 5 elements are often cut/prepared to suit each patient. These additional elements alter the profile of the insole 1 so it ensures the orthotic corrects the patient’s foot posture as required.

The guides also assist the practitioner in being consistent in placing the prescription in the correct positions. This is illustrated in Figure 18. ίο Specifically, the following positional guides are imprinted: • Lateral Forefoot Reinforcement (200) - Positional guiding imprints to apply prescription forefoot control (by the practitioner) to elevate the 2nd-5th metatarso-phalangeal joints to offload or apply a pronatory force. • Medial Forefoot Reinforcement (204) - Positional guiding imprints to apply 15 prescription forefoot control (by the practitioner) to elevate the 1st metatarso-phalangeal joint to offload or apply a supinatory force. • Positional guiding imprints 202 to apply prescription forefoot control (by the practitioner) to elevate the metatarsals to decrease pressure, in particular elevating the 2nd to 4th metatarsal shafts. 20 The lower surface 14 further comprises at least one marking delineated thereon identifying where the part may be altered in the form of: • "Cut to Sulci" feature 206 that allows first part 2 (and therefore the insole 1) to be trimmed down from full length • “Slim cut” feature 207 that allows first part 2 (and therefore the insole 1) to 25 be trimmed from full length to 3Λ • "Cut to Size" feature 208 that allows customising of the fit of the insole 1 to different shoes

The first part 2 is made from any suitable material such as dense ethylene vinyl 2012261588 24 Jan 2017 - 14- acetate (EVA) with a hardness of 40 to 80, preferably 60 to 70.

The second part 3 comprises a second arch portion in the form of contoured portion 17, a stabilising member in the form of a bar member 18 and a heel supporting member in the form of U shaped portion 15. The contoured portion 17 5 being located adjacent one upright of the U shaped portion 15. The bar member 18 extends between the ends of the U-shaped portion 15 such that the bar member 17, the U-shaped portion 15 and the contoured portion 17 form a unitary member. The connecting bar 18 is a support and stabilization means to provide forefoot and midfoot stability and increased support and control. ίο The second part 3 also defines a void or cut out portion 19 that is formed to receive a correspondingly shaped projection 21 in the first part 2 to provide the flat, continuous underside surface 11 and assist with the joining of the first 2 and second parts 3.

The U-shaped portion 15 includes an angled outer side wall 16 which is 15 dimensioned to fit against and to reinforce the raised edge 9 and the arch support portion 8’ of the first part 2.

When the second part 3 is received in the recess 10 of the first part 2, the bar member 18 runs under the wearer’s foot at a position located just proximal to the metatarsal phalangeal joints. The bar extends from the lateral to the medial 20 aspect of the forefoot supporting the five metatarsals.

The second part is made of thermoplastic polyurethane (TPU) of a hardness of 70 to 95, preferably 80 to 90 or any other suitable material. It provides stability, it is semi-flexible, reduces bulk of the insole 1 with no compression and minimal deformation properties. 25 The first and second parts can be joined by a variety of means apparent to those skilled in the art. For example, they may be fixed together in a molding process or joined by an adhesive 2012261588 24 Jan 2017 - 15-

The insole 1 can be provided with an anti-slip and antimicrobial covering of any suitable material. A number of durable and controlling adhesive additions can be used specifically for this device. These include the following: 5 1. EVA (hardness 70 to 95, preferably 80) heel raise in 4mm and 6mm thicknesses. One sided adhesive. 2. EVA (hardness 70 to 95, preferably 80) sheeting, sized at A4 sheets, in 3mm and 5mm thicknesses. One sided adhesive. 3. EVA (hardness 70 to 95, preferably 80) wedging, in 1 metre lengths, in ίο 3mm and 5mm thicknesses. One sided adhesive.

These are to be used by the practitioner to apply to insole at the positional guides discussed above. The practitioner can also apply these prescriptive additions to the rearfoot and midfoot regions of the insole to apply control as per the patient’s requirements. is Modifications are possible within the scope of the present invention.

Claims (17)

1. An insole consisting essentially of two parts and defining a forward region, a rearward region, and a mid region, the mid region further including a lateral region including an outer edge and a low arch region including an outer edge, the insole comprising: (i) a first part consisting of a unitary member with a hardness of at least 40A including an upper surface for contacting the sole of a foot, when in use, and a lower surface including a recessed portion and a projection that extends away from the upper surface and from the rearward region to the mid region; and (ii) a second part, adapted to be received in the recessed portion, for reinforcing or stabilising the forefoot and midfoot region of the foot and including an elongate stabilising member located forward of the low arch region and extending transversely between the outer edge of the lateral region and the outer edge of the low arch region for supporting the metatarsals of a user, said second part further comprising an aperture adapted to receive the projection.

2. An insole according to claim 1 wherein an upper surface of the second part forms at least part of the low arch region of the insole.

3. An insole according to claim 2 wherein the upper surface of the second part that forms the at least part of the low arch region of the insole comprises a second arch portion formed by contouring the upper surface of the second part upwards to provide a curved, inclined surface.

4. An insole according to any one of the preceding claims wherein the upper surface of the first part forms at least part of the low arch region of the insole.

5. An insole according to claim 4 wherein the upper surface of the first part that forms at least part of the low arch region of the insole comprises a first arch portion formed by contouring the upper surface upwards to provide a curved, inclined surface.

6. An insole according to any one of the preceding claims wherein the upper surface of the first part comprises a raised portion located to support the metatarsal portion of a user’s foot, when in use.

7. An insole according to any one of the preceding claims wherein the upper surface of the first part includes a contoured perimeter edge formed by contouring the upper surface upwards towards its perimeter edge to provide a curved, inclined surface.

8. An insole according to claim 7 wherein the height of the contoured perimeter edge is higher at a part of the first part that is positioned in the rearward region of the insole that receives the heel of the user’s foot, relative to a part of the first part that is positioned in the forward region of the insole.

9. An insole according to any one of the preceding claims wherein the first part further comprises at least one region delineated thereon for receiving an additional bolster member for raising the insole at a predetermined location.

10. An insole according to any one of the preceding claims wherein the first part further comprises at least one marking delineated thereon identifying where the first part may be altered, such as by cutting, to alter its length, width and/or shape.

11 .An insole according to any one of the preceding claims wherein the recessed portion of the first part defines a transverse portion that extends between the outer edge of the lateral region and the outer edge of the low arch region of the insole.

12. An insole according to any one of the preceding claims wherein the recessed portion of the first part defines a lip portion that abuts an outside upper edge of the second part.

13. An insole according to any one of the preceding claims wherein the height or thickness of the low arch region is about 15-30mm.

14. An insole according to claim 13 wherein the height or thickness of the low arch region is less than or equal to 19mm.

15. An insole according to any one of the preceding claims wherein the second part includes a heel supporting member located in the rearward region that has a generally “U” shaped member comprising two opposed upright portions and a curved portion therebetween shaped to support the heel in a wrap around fashion, wherein said upright portions extend up both sides of the rearward region and the curved portion extends around the heel in the rearward region.

16. An insole according to any one of the preceding claims wherein the first part is made of a first material having a first hardness and the second part is made of a second material having a second hardness that is greater that the first hardness.

17. An item of footwear comprising an insole according to any one of claims 1 to 16.