GB2465350A

GB2465350A - A device for the treatment of ulcers

Info

Publication number: GB2465350A
Application number: GB0820724A
Authority: GB
Inventors: Charles Byrne
Original assignee: Salisbury NHS Foundation Trust
Current assignee: Salisbury NHS Foundation Trust
Priority date: 2008-11-12
Filing date: 2008-11-12
Publication date: 2010-05-19
Also published as: GB0820724D0

Abstract

The device comprises a generally tubular sock 10 having a front portion and a rear portion, a support member 22 and a retaining means, such as pocket 20, for connecting the support member to the sock. The retaining means may be arranged to releasably retain the support member so as to extend from the rear portion of the sock. In use the sock extends along and around at least a portion of the lower leg of the subject. The support member is of a size sufficient to extend between the rear portion of the lower leg and a surface on which the subject is lying such that the heel of the subject is held above and out of contact with the surface.

Description

I

DEVICE FOR PREVENTING AND TREATING ULCERS AND METHOD OF

USING THE SAME

The present invention relates to a device for preventing and treating ulcers, more particularly ulcers on the foot of a subject. The device is especially suitable for the prevention and/or treatment of ulcers on the heels of subjects.

Ulceration, in particular ulceration of the feet, occurs in people suffering from a wide range of conditions, including the vascular impaired, geriatric people, subjects suffering a stroke and the long term bed bound. It is estimated that 85% of lower limb amputations are preceded by ulceration of :.::15 the foot which fails to heal. Diabetics are particularly vulnerable to ulceration * S..

of the feet. Again, it is estimated that foot ulceration affects 1 in 7 diabetes sufferers at some stage during their lifetime. Once ulcerated, it is further estimated that a diabetic is 58 times more likely to experience a reoccurrence * ,. of the foot ulcers. One area of the foot particularly prone to ulceration is the heel. Once ulcerated, the treatment of the heel is very difficult and non-S....

* healing heel ulcers are frequent. In the United Kingdom alone, there are approximately 450,000 heel ulcers diagnosed each year.

A particular problem arises in connection with the treatment or prevention of ulcers of the heel. When the subject is lying in a supine position, the heel is a major contact point for the subject with the surface on which the subject is lying. The abrasion between the heel of the subject and the surface can cause the onset of heel ulcers in vulnerable subjects. Such abrasion is effective in exacerbating a heel ulcer and preventing it from healing, once the heel is ulcerated. When sleeping, the subject typically adopts a supine position for extended periods of time. For subjects that are bed ridden or are required to spend extended periods of time in bed, it is generally impractical for them to spend the time in a side-laying or prone position and avoid the supine position.

Accordingly, there is a need for a way of treating foot ulcers, in particular ulcers of the heel. Further, there is a need for a system for preventing foot ulcers from forming, in particular to prevent the heels of subjects from ulcerating. The system should be effective in preventing and alleviating heel ulceration when the subject is in a lying position, in particular when in the supine position.

US 4,278,079 discloses a therapeutic support device to prevent decubitus ulceration of the heel of a subject or to assist in the healing of such ulceration once formed. The support device comprises a resilient body having a plurality of separable, resilient layers assembled in a stacked arrangement **..

and held together by straps. Each layer is formed with an aperture therein, such that when the layers are stacked a central chamber is formed for receiving the heel of a subject. The device acts to support the foot of the * ** subject when in a supine or side-laying position, the foot being held in an 2O elevated position above bed or surrounding surface. The number of layers in **.*** * the stack may be varied according to the weight of the foot of the subject. The device of US 4,278,079 is particularly bulky and difficult to arrange for the subject. In addition, the device is not suitable for a subject that needs to leave his or her bed or otherwise move their legs.

US 4,409,975 discloses a support device very similar in construction to that of US 4,278,079, comprising a plurality of resilient layers in a stack and forming a central chamber for receiving the heel of a subject. The device further comprises a top layer having a groove or cut-out portion for receiving the Achilles' tendon area of the foot. In addition, the bottom surface of the bottom layer is provided with pockets for decreasing the surface contact of the device. Finally, the peripheral lateral walls of the device are concave, to accommodate the foot of the subject when in a side-laying position. The disadvantages of the device of US 4,409,975 are as described above in relation to the device of US 4,278,079.

A number of devices for the treatment or alleviation of foot ulcers, in particular ulceration of the heel are commercially available.

One such device comprises an inflatable collar that is applied around the ankle of the subject. Once inflated, the collar holds the heel of the subject above the surface on which the subject is lying. The collar is lined with shearling to increase the comfort for the subject.

**a A commercially available device is described in US 5,449,339. The :.:.15 device is a heel supporting protective boot to be worn by subjects when in * *.* bed. The boot comprises a body formed from compressible, flexible foam that extends around the lower leg and foot of the subject. The boot supports the subject's leg with the heel elevated above the surface of the bed. The outer * *. surface of the body may be covered in a low friction material, to ease movement of the leg by the subject. The device of US 5,449,339 is S... SP * particularly cumbersome to apply and wear. In addition, the device is not well suited to the subject leaving the bed or otherwise moving around.

A further commercially available device is the so-called pressure relief ankle foot orthosis' or PRAFOTM. US 6,350,246 discloses a device of this generally kind. The device comprises a plurality of straps and supports which extend around the foot and lower leg. The straps and supports are arranged to protect the heel of the subject from pressure, while still providing for movement of the leg. The device is intended for use while the subject is standing upright and moving, as well as when the subject is in a lying position.

While the PRAFOTM devices are widely used, they are expensive to manufacture and are complex and bulky to fit and wear.

Accordingly, there is a need for an improved device that can prevent ulceration of a subject's heel or assist in treating and healing heel ulcers.

According to the present invention there is provided a device for the treatment of ulcers of the foot, the device comprising: a generally tubular sock for extending around at least a portion of the lower leg of the subject the sock having a front portion and a rear portion, in use the rear portion being disposed at the rear of the lower leg of the subject; a support member, in use the support member extending between the lower leg of the subject and a surface on which the subject is lying; and a retaining means for connecting the support member to the sock, the *:.::15 retaining means being arranged to retain the support member so as to extend * .GS from the rear portion of the sock. * *

The device of the present invention comprises a generally tubular sock.

The sock is adapted to extend around the lower leg and, most preferably, at least a portion of the foot of the subject. One preferred embodiment *.*.** comprises a sock that covers the entire lower leg and foot of the subject. In such a case, the sock is of a largely conventional configuration, that is generally tubular with one open end and one closed end. An alternative embodiment comprises a sock that covers the lower leg, as well as the heel and arch portions of the foot, the sock having an opening through which the toes of the foot may extend and remain uncovered. In embodiments where the sock covers none or only part of the foot of the subject, the sock is in the form of a tube having an opening at both ends.

The sock may be formed from any suitable material, with suitable materials being well known in the art and commercially available. The sock may be formed of an elastic material, so as to provide a general compression sock. Suitable materials for the sock are known in the art and include cotton fabrics, in particular fabrics comprising cotton in combination with other materials, especially polymeric materials. The material is preferably composed to provide at least some elasticity and to allow the sock to conform to the shape of the leg and foot of the user. A material comprising cotton in combination with elastomeric fibres, for example elastane commercially available under the name LycraTM.

The sock is most preferably of a material that is antibacterially and/or antimicrobially active. This activity may be achieved in known manner. For example, the material of the sock may be impregnated with an antibacterial or antimicrobial agent. Such agents are known in the art. Alternatively, the material may have a suitable agent woven therein. Again, such materials, for example those containing silver, are known in the art. As a further alternative, the sock may be provided with an antibacterial or antimicrobial layer, for example an inner or outer layer.

*S I..S * * * ** A sock formed from an elastic material will be self-supporting, that is :20 remain in position on the lower leg and foot of the subject. However, if **s..* * S desired, the sock may be provided with a suitable means to retain the sock in position on the leg and foot of the subject. Suitable means are well known in the art and include an elasticated portion of the sock adjacent one or both of its openings.

The device of the present invention further comprises a support member. In use, the support member extends between the lower leg of the subject and the surface on which the subject is lying. The support member is of a shape and is disposed in a position such that, in use, the support member extends rearwards from the rear of the sock and leg of the user. The function of the support member is to bear upon the surface on which the user is lying, such that the lower leg and foot of the user are raised. The support member should be arranged to at least reduce the pressure on the foot of the subject arising from contact with the surface. More preferably, the support member is arranged to raise the lower leg and foot of the user sufficiently to be above and out of contact with the surface. In particular, the support member is preferably configured to ensure that the heel of the foot of the user is held out of contact with the surface on which the user is lying.

The support member may be of any suitable shape, such as to perform the function described hereinbefore. In one embodiment, the support member is shaped to extend rearwards from the lower leg of the subject, but with no substantial protrusion to either side of the leg of the user. In this way, the user may rest the side of their leg and foot on the surface on which they are lying, for example when in a side-lying position, in a conventional manner, without *::.15 interference from the support member. *..

Alternatively, the support member may extend both rearwards and laterally from the lower leg of the subject, such that the lower leg and foot of * *. the subject are held above the surface when the user is lying in a supine .20 position or a side-lying position. In such an embodiment, the support member * extends circumferentially around the lower leg of the subject. If extending circumferentially in this manner, the support member most preferably does not extend around the complete circumference of the leg, that is form a complete collar. Rather, the support member extends only partially around the leg, that is forms a partial collar around the lower leg. Preferably, the support member extends through an arc of less than 180, more preferably less than 120°, even more preferably through an angle of 90° or less. If the support member extends laterally from the lower leg of the user when in use, it may extend an equal distance on both sides or may extend further from one side of the lower leg than the opposing side. For example, the support member may be arranged to prevent the heel and outer portion of the foot of the subject from contacting the surface on which the user is lying, but allow the inner portion of the foot to come into contact with the surface, or vice versa.

The support member may be of a size so as to extend any suitable distance along the lower leg of the subject. In use, the support member is disposed on the rear portion of the lower leg between the ankle and the knee of the subject. The support member is preferably sized to extend along at least 25% of the distance between the ankle and the knee of the subject, more preferably at least 35%, especially at least 50%. In some cases, as may be required by the circumstances of a given subject, the support member may be formed to extend greater than 70%, more preferably greater than 80% of the distance between the ankle and the knee of the subject, such that the majority of the lower leg is provided with support.

In use, the support member bears directly or indirectly onto the lower leg of the user. Accordingly, the support member should be formed to provide as little discomfort as possible for the user when supporting the lower leg and foot.

The support member may consist of a single member. Alternatively, ** the support member may comprise a plurality of members which combine to provide support for the lower leg and foot of the user, Preferably, the support member is unitary consisting of a single component. * .

* 25 In one preferred embodiment, the support member comprises a block or pad of support material. The block may be any suitable shape that provides sufficient support for the lower leg and foot of the subject with minimum discomfort to the user. In particular, when in use, the block extends rearwards from the lower leg of the subject a sufficient distance to hold the lower leg and foot of the subject above and clear of the surface on which the subject is lying. To increase the comfort to the user, the block or pad may be arcuate, so as to extend around at least the rear portion of the lower leg of the subject. Alternatively, the block or pad may be formed with a groove or an arcuate surface which, in use, is adjacent the lower leg of the subject and accommodates the rear portion of the lower leg of the user.

The support member may consist of a single block or pad.

Alternatively, the support member may comprise two or more blocks or pads, arranged to extend as desired around the lower leg and to provide the desired clearance between the lower leg and foot, most especially the heel, of the subject and the surface on which the subject is lying.

The or each block or pad may be made of any suitable material, such that the requisite support for the lower leg and foot of the user is provided.

The material may be rigid, for example a rigid polymer. Alternatively, the material may be flexible and/or resilient, such as a gel or a foam. The properties of such materials should be such that the lower leg and foot of the user are supported, preferably such that the heel of the subject is held above and clear of the surface on which the user is lying.

Suitable materials for forming the support block or pad are known in the art and include polymers, in particular polyurethanes. To provide increased * comfort for the user, the surface of the block or pad adjacent the leg of the subject may be provided with a layer of foam or the like. * *

***.S* * *25 The device of the present invention further comprises a means to retain *:*::* the support member in connection with the sock. The retaining means hold the support member in place, such that is extends rearwards from the lower leg of the wearer. The retaining means should hold the support member in a position at the rear of the lower leg of the user between the ankle and the knee. The support member should be disposed sufficiently close to the ankle to ensure that the heel of the foot is held clear of the surface on which the user is lying. The retaining means preferably holds the support member in position on the rear of the lower leg such that the support member is clear of the Achilles tendon of the subject.

The retaining means may be any suitable means to hold the support member in position on the sock. In one embodiment, the support member is permanently connected to the sock. Suitable permanent connection means include adhesive and forming the support member integrally within the structure of the sock.

In a particularly preferred embodiment, the retaining means are such that the support member is removable. In this way, a given sock may be fitted with one of a variety of different sized and shaped support members, so as to best suit the subject. Suitable removable retaining means include releasable fasteners, in particular hook and loop fasteners.

In an especially preferred embodiment, the retaining means comprises a pocket formed in the sock, so as to be disposed on the rear portion of the lower leg when in use. The pocket is preferably formed on the exterior of the sock. The support member is housed in the pocket and retained in position.

The pocket may be formed from any suitable material, for example the same * * material as the sock. In one embodiment, the pocket is formed from an elastic * S..

material, such that one of a range of support members of different sizes may S.....

* : be housed and securely held in place on the rear portion of the lower leg, *S 55 * 25 when in use. * .. * S S * **

As noted above, the support member is most preferably arranged to be removable from the sock, such that the sock and support member may be interchanged, so as to better fit the subject and their circumstances and condition. Accordingly, the present invention also provides a kit comprising at least one of the sock and the support member as hereinbefore described and a plurality of at least one of a sock and a support member as hereinbefore described.

As noted above, the device of the present invention is particularly suitable for the prevention of and treatment of ulcers on the feet of subjects, in particular ulcerated heels. Accordingly, in a further aspect, the present invention provides a method of preventing the formation of ulcers on the foot of a subject or treating an ulcer on the foot of a subject, the method comprising: providing a sock to extend along and around at least a portion of the lower leg of the subject; providing a support member of a size sufficient to extend between the rear portion of the lower leg of the subject and a surface on which the subject is lying such that the heel of the subject is held above and out of contact with the surface; and securing the support member to the rear portion of the sock, such that the support member extends rearwards from the lower leg of the subject.

Details of the sock, the support member and the means for securing the support member to the sock are as described hereinbefore. As noted, it is particularly preferred that the support member is releasably fastened to the *::::* sock. In particular, the support member is most preferably retained within a pocket on the rear portion of the sock. * *

S.....

* 25 An embodiment of the present invention will now be described, by way *:*:: of example only, having reference to the accompanying drawings, in which: S.....

S S

Figure 1 is a side view of the lower leg of a subject wearing a device according to one embodiment of the present invention; and Figure 2 is a perspective rear view of the lower leg and device of Figure 1.

Referring to Figure 1, there is shown a device, generally indicated as 2, in position on the lower leg 4, foot 6 and heel 8 of a subject. The device 2 comprises a sock 10, of largely conventional design, As shown in the figure, the sock 10 extends so as to cover the lower leg 4 and the major portion of the foot 6 of the subject. The sock 10 is generally tubular in form, and may be shaped to fit the heel 8 and the foot 6 of the subject, again in known manner.

The sock 10 has an upper opening 12, for extending around the lower leg 4 of the subject, in particular in the region of the calf, as shown in the figure. The sock 10 further has a lower opening 14 extending around the foot, through which the toes 16 of the subject extend and are left exposed. In an alternative embodiment, the sock 10 may have a closed lower end such that the toes of the subject are fully covered, again in known and conventional manner.

The sock 10 is formed from a generally elastic fabric, such that it is retained in close contact and fit with the lower leg and foot of the subject. The sock is further provided with a band 18 of elasticated material around the upper opening 12. The band 18, of conventional form, serves to keep the *:::* sock 10 in position on the lower leg of the subject. The lower opening 14 of *::::* the sock 10 may also be provided with an elasticated band, although no band is shown in the figures. * * *

***.S* * *25 The fabric of the sock 10 may be treated so as to be anti-bacterial. * S. * S S * **

The device 2 further comprises a pocket 20 securely attached to the exterior of the sock 10. The pocket 20 may be attached to the exterior of the sock in any suitable manner, for example by stitching, as indicated in the figures. Alternatively, the pocket 20 may be formed integrally with the sock.

As shown in Figures 1 and 2, the pocket 20 is positioned on the sock 10 so as to be disposed on the rear or calf portion of the lower leg of the subject, when the sock 10 is being worn in the normal and intended manner. The pocket 20 has an opening therein (not shown in the figures for clarity) to provide access to the interior of the pocket.

As shown more clearly in Figure 2, a support member 22 is disposed within the pocket 20. The support member 22 is an arcuate block of support material. The radius of curvature of the support member 22 is selected to match the curvature of the calf of the lower leg of the subject, so as to provide the maximum comfort to the subject when in use.

The support member 22 is formed from a suitably rigid material, that will not yield or be deformed significantly by the weight of the lower leg and foot of the subject. One suitable material is polyurethane The support member 22 is preferably formed from a material that is anti-bacterial or that is easily cleaned and sterilised. To improve the comfort for the subject, the support member 22 is provided with a layer of foam material (not shown for clarity) on the surface adjacent to and bearing upon the leg of the sybject, when in use.

*...,. As shown more clearly in Figure 1, the support member 22, when in position in the pocket 20, extends rearwards from the lower leg 4 of the subject, typically projecting from the calf of the subject. The support member * ***** * 22 is positioned to lie against the rear portion of the lower leg of the subject ***.** * 25 above the heel and, most preferably, above the Achilles tendon. The support *:::* member 22 is shaped to extend sufficiently far from the rear portion of the lower leg so as to extend beyond the heel.

By providing the pocket 20 with an opening, the support member 22 may be removed and replaced within the pocket, for example to allow both the support member and the sock to be cleaned, the latter being laundered in a conventional manner. Further, a sock 10 may be provided with a plurality of support members of different sizes, such that the support member may be selected to best fit the subject. A single support member may also be provided together with a plurality of socks, allowing the socks to be changed and cleaned without interrupting the treatment of the subject.

In use, the device 2 is arranged on the lower leg and foot of the subject as shown in the figures. When the subject is lying in a supine position on a surface, such as a bed, the heel of the foot extends towards the surface and, ordinarily, would contact the surface. This contact causes and exacerbates ulcers in subjects susceptible to ulceration, such as persons with diabetes.

With the device of the present invention in place, the support member extends rearwards from the lower leg and contacts the surface on which the subject is lying. The support member is sized to reduce the pressure of contact between the heel and foot of the subject and the surface on which the subject is lying, more preferably to hold the heel of the subject raised above and of contact with the surface, thereby preventing the onset of ulceration and allowing existing ulcers to heal more effectively.

In the embodiment shown in the figures, in particular Figure 2, the *... support member extends across the rear portion of the lower leg, but does not *::::* substantially extend across or from the sides of the lower leg. Thus, in use, the subject may lie in a side-lying position and have the side of the foot in * contact with the surface. The pocket and the support member may be greater ** *.** * *25 in size than that shown in the figures, so as to extend around one or both sides of the lower leg. In this way, the support member will also extend laterally from one or both sides of the lower leg, in use acting to support the lower leg and foot in a side lying position, as well as a supine position. A separate pocket may be provided on one or both sides of the sock, allowing one or more further support members to be used with the sock, as an alternative to using a single, large support member.

Claims

CLAIMS1. A device for the treatment of ulcers of the foot, the device comprising: a generally tubular sock for extending around at least a portion of the lower leg of the subject the sock having a front portion and a rear portion, in use the rear portion being disposed at the rear of the lower leg of the subject; a support member, in use the support member extending between the lower leg of the subject and a surface on which the subject is lying; and a retaining means for connecting the support member to the sock, the retaining means being arranged to retain the support member so as to extend from the rear portion of the sock.
2. The device according to claim 1, wherein the sock is arranged to cover the lower leg and a portion of the foot of the subject, when the device is in use.
3. The device according to claim 2, wherein the sock is arranged, in use, *::* to cover the entire foot of the subject. * * *S**
4. The device according to any preceding claim, wherein the material of ****** * the sock is elastic.S..... * *25
5. The device according to any preceding claim, wherein the material of the sock is antibacterially or antimicrobially active.
6. The device according to any preceding claim, further comprising means to retain the sock in position on the leg of the subject.
7. The device according to claim 6, wherein the said means comprises an elasticated portion of the sock adjacent at least one of its openings.
8. The device according to any preceding claim, wherein the support member is shaped to extend from the rear of the lower leg of the subject, when in use, but with substantially no protrusion from the sides of the leg of the subject.
9. The device according to any of claims 1 to 7, wherein the support member extends both rearwards and laterally from at least one side of the lower leg of the subject, when in use.
10. The device according to any preceding claim, wherein the support member is a single member.
11. The device according to any preceding claim, wherein the support member is a block of support material.
12, The device according to claim 11, wherein the block is formed with an *::,* arcuate surface to accommodate the rear portion of the lower leg of the subject.S.....

*
13. The device according to any preceding claim, wherein the support *SSS * 25 member is antibacterially or antimicrobially active. * *5 * . S * *.
14. The device according to any preceding claim, wherein the retaining means holds the support member between the ankle and the knee of the subject, when in use.
15. The device according to claim 14, wherein the retaining means holds the support member clear from the Achilles tendon of the subject, when in use.
16. The device according to any preceding claim, wherein the retaining means is arranged to allow the support member to be removed from the device.
17. The device according to any preceding claim, wherein the retaining means is a pocket formed in the sock.
18. The device according to claim 17, wherein the pocket is on the exterior of the sock.
19. The device according to either of claims 17 or 18, wherein the pocket is formed from an elastic material.
20. A kit comprising at least one of each of the sock and the support member as defined in any preceding claim, the kit comprising at least one of the sock and the support member in a plurality. * ** * * * * ***::::*
21. A method of preventing the formation of ulcers on the foot of a subject or treating an ulcer on the foot of a subject, the method comprising: * ****.* providing a sock to extend along and around at least a portion of the S.....

* 25 lower leg of the subject; providing a support member of a size sufficient to extend between the rear portion of the lower leg of the subject and a surface on which the subject is lying such that the heel of the subject is held above and out of contact with the surface; and securing the support member to the rear portion of the sock, such that the support member extends rearwards from the lower leg of the subject.
22. The method according to claim 21, wherein the support member is releasably fastened to the sock, the method comprising selecting one of a plurality of support members for use with the subject.
23. A device for the prevention or treatment of ulcers on a subject substantially as hereinbefore described having reference to the accompanying figures.
24. A method for the prevention or treatment of ulcers on a subject substantially as hereinbefore described. * *S * * * * I. S... * * * ** **..* * . *S..... * . * S* * . . * S. * 0