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healix offload cataloguethe ultimate in diabetic footwear
Reed Medical in partnership with Tekscan
Reed Medical Ltd: Thwaites Close, Shadsworth Business Park,Blackburn, Lancashire, United Kingdom BB1 2QQ. Tel +44 (0)1254 503333E-mail [email protected] Website www.reedmedical.co.uk
the concern
According to the World Health Organisation, the global diabetic population will exceed 366 million by 2030. In the UK, the National Health Service spends £1,000,000 (1 million) per hour on treating Type 1 and Type 2 diabetes. This is approximately 10% of the total annual NHS budget. According to The International Consensus on the Diabetic Foot, 85% of all diabetes related lower extremity amputations are preceded by a Diabetic foot ulcer. Approximately 15% of the UK diabetic population will experience a foot ulcer, with between 2 and 4% of the UK diabetic population being treated for ulcers at any one time. Inappropriate footwear has been identified as a causative factor in the development of Diabetic plantar ulceration. Evidence in the medical literature suggests rocker soled shoes offer advantages in reducing force and pressure under the “at risk” neuropathic foot.
the research
The research and development team at Reed Medical have developed a unique twin axis rocker sole that offers the healthcare professional an evidence based alternative to current diabetic footwear. Reducing the magnitude and duration of pressure experienced under the neuropathic foot is now considered a priority for patients at risk of plantar ulceration. Footwear supplied to patients considered at risk of plantar ulceration should demonstrate design features to reduce the likelihood of the shoe becoming a causative factor in plantar ulceration development. The Reed Medical healix shoe is designed to reduce the mechanical stress under the foot compared to other shoe designs.To establish the effectiveness of the patented healix design, in-shoe pressure data was gathered from eight pairs of U.K. commercially available diabetic footwear and compared to healix footwear.
the evidence
Using the Tekscan pressure measurement system, data was collected from a single subject walking on a treadmill at 4 kilometres per hour. A comparison of the results between the healix shoe and eight randomly selected diabetic shoes, indicate that the healix design reduces the peak pressure and the pressure time duration under the heel, the metatarsal heads and the toes.healix footwear from Reed Medical represents a significant development in footwear design for the neuropathic foot. healix footwear demonstrates lower under foot pressures and forces in areas of high risk of ulcer formation. By reducing the possibility of a first ulcer and the incidence of re-ulceration, Reed Medical believe that healix footwear will make a major contribution to reducing the cost burden of treating neuropathic ulceration and significantly reduce ulceration rates within the global diabetic population.
the evidence based choice
Data was gatheredfrom eight pairs ofU.K. commercially available diabetic footwear andcompared tohealix footwear.
page 3
healix
healix. a valuable lessen Reed Medical in partnership with Tekscan
why healix?
The healix range of diabetic footwear has been specifically designed to minimise the risk of plantar ulceration of the Neuropathic diabetic foot. healix footwear uses Reed Medical’s unique patented dual axis rigid rocker sole design, Reed Medical’s innovative ‘SafeSeam’ upper technology and Reed Medical’s ‘front line’ Polyurethane insole system.
why rigid rockers?
Recent published research indicates that a rigid rocker sole design is more effective in off-loading the mechanical stresses and strains experienced under the neuropathic foot. The healix dual axis rocker places the rocker point of the shoe behind the anatomical axis of the metatarso-phalangeal joints of the foot, reducing the force and pressure at this high ulcer risk area.
whyupper construction?
The neuropathic diabetic foot is susceptible to abrasion and friction from the upper of the shoe. safeseam construction locates any necessary upper seams in areas of the foot where the risk of abrasion is at an absolute minimum. Leather uppers are constructed using the lap seam method ensuring even thickness and pressure. Upper linings uses the safeseam closed seam method to create seams with no variation in upper thickness or internal surface pressure making the internal surface of the shoe smooth and free from potential seam hazards.
why ‘front line’ polyurethane insoles?
Published research indicates that insoles made from polyurethane offer exceptionally good shock attenuation and pressure relieving characteristics and have the advantage in that polyurethane resists compression set or ‘bottoming out’. Reed Medical’s front line PU insoles are contoured to accommodate the anatomical shape of the foot and are removable to allow for the insertion of custom made orthoses. We recommend custom insoles manufactured from P.U. block.
why 3 widthsand 2 depths?
Reed Medical understands that the foot comes in all shapes and sizes, that’s why we offer a range of three width fittings to accommodate foot width variation and two depth options to allow for the use of custom made orthoses.
external features
Removable, contoured, lowshear polyurethane inlay
Quality leather
Low friction, seam-free,anti-bacterial interior
safeseamconstruction
Rim toe puff
Pressurerelievingpaddedtongue
Left and rightindicated in braille
Low impactchamfered heel
High M.V.T.R rating
Geometrically stabledual density sole
Dual axis high gear -low gear rocker
Oeko-Tex St 100class 3 lining
Anatomical toe shape
Recent studies by the REED Medical Research team indicate that Polyurethane (PU) displays superior pressure reduction and force reduction properties over Ethylene Vinyl Acetate (EVA) when used in the manufacture of foot orthoses and insoles. Total contact insoles (TCI) made from Low density P.U. (LDPU) demonstrate reduced peak force and reduced peak pressure under the heel and metatarsal areas of the foot when compared to the same insoles made from EVA. PU insoles also demonstrate a higher degree of contact area under the foot when compared to the same insoles made from EVA. Unlike EVA, PU insoles do not compress or “bottom out” under areas of high contact pressure and offer improved impact absorption properties, making PU insoles safer choice for the “at risk” foot.
REED Medical are now offering the manufacture of TCI in PU or the purchase of PU block to clinicians.
3 Narrow waist3 Internal Bi-planar heel radii3 Negative heel height3 Minimal heel pitch
internal features
patented sole geometry
3º20º
test shoe#219/5/11Default axis 60@19
25
90
40%60%
design details
Rocker based on the “high gear /low gear” dual axis metatarsal extension model as describedby Bojsen MØller (1979)
Position of high gear axis placedat 60% of foot length as described by van Schie et al (2000)
Transverse medial axis perpendicular to longitudinalbisection of foot
Oblique axis 25 degreesfrom perpendicular basedon average met position
Sagittal plane rockerangle 20 degrees
Negative pitch angle 3 degrees
healix. a valuable lessen Reed Medical in partnership with Tekscan page 5
validation test
3Compare in-shoe force and pressure values at five discreet sites.
3healix vs.UK’s 8 most popular “Diabetic Shoes”
trial methodology
3Single subject comparison
343 y.o.a active male
380.6Kg body weight
3No known gait or biomechanical abnormalities
3Treadmill walking @ 4Km/Hr (1.1 mtr/sec)
324 hour treadmill familiarisation
3Footwear identity withheld from subject
3Research 6:3 system
3New sensors prepared and calibrated as per Tekscan recommended protocols
310 seconds of data collection
3Sample frequency 50hz (500) frames
design validation and methodology
discreet areas data processing
Measurements taken for Impulse Kgs/Sec and Integral Kpa/Sec
Average phase of 10 steps1st and last frames discardedData values exported as ASCII files to Padowan Graph 4.3 software Integral and Impulse values calculated usingPadowan software
Metatarsal2-5
1stRay
Mid foot
Rear foot
Whole foot
healix. a valuable lessen Reed Medical in partnership with Tekscan
test results healix versus 8 commonly prescribed diabetic footwear brands
Full foot pressure integral Kpa/sec Full foot force impulse Kg/sec
6Healix
6.5
7
7.5
8
8.5
9
9.5
10
Whole Foot Avg Integral KPa/Sec Whole Foot Avg Impulse Kgs/ Sec
3Healix
3.5
4
4.5
5
5.5
6
6.5
7
Midfoot 1st Ray
Midfoot Integral Kpa/Sec Midfoot Impulse Kgs/Sec
0Healix Healix
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
0.6
0.8
1
1.2
1.4
1.6
1.8
0Healix Healix
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
0.6
0.8
1
1.2
1.4
1.6
1.8
1st Ray Integral KPa/Sec 1st Ray Impulse Kgs/Sec
0.5HealixHealix
0.7
0.9
1.1
1.3
1.5
1.7
1.9
0.6
0.8
1
1.2
1.4
1.6
1.8
0.5HealixHealix
0.7
0.9
1.1
1.3
1.5
1.7
1.9
0.6
0.8
1
1.2
1.4
1.6
1.8
Mets 2-5 Rearfoot
Mets 2-5 Integral KPa/Sec Mets 2-5 Impulse Kgs/Sec
0.5Healix Healix
0.7
0.9
1.1
1.3
1.5
1.7
1.9
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
0.5Healix Healix
0.7
0.9
1.1
1.3
1.5
1.7
1.9
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
Rearfoot Integral Kpa/Sec Rearfoot Impulse Kgs/Sec
0.4Healix Healix
0.6
0.8
1
1.2
1.4
1.6
1.8
2
0.5
0.7
0.9
1.1
1.3
1.5
1.7
1.9
2.1
0.4Healix Healix
0.6
0.8
1
1.2
1.4
1.6
1.8
2
0.5
0.7
0.9
1.1
1.3
1.5
1.7
1.9
2.1
page 7
healix. a valuable lessen Reed Medical in partnership with Tekscan
healix test results
conclusion
The healix shoe design has shown performance characteristics considered beneficial to the reduction of plantar ulceration when compared to other Diabetic footwear. Reduction of forceand pressure under the foot are considered beneficial in ulcer risk reduction.
full foot pressure integral Kpa/sec
mean % reduction
Pressure Integrals kpa/sec Force Impulse kgs/sec
Min % reduction Max % reduction Min % reduction Max % reduction
Whole footRear foot1st RayMets 2-5
-22.62%-45.46%-15.67%-38.38%
-34.34%-66.6%-58.83%-70.56%
-26.67%-47.42%-16.1%-38.9%
-34.33%-68.23%-57.06%-70.75%
kpa/sec mean % reduction kgs/sec mean % reduction
Whole footRear foot1st RayMets 2-5
-28.48%-56.03%-37.27%-54.47%
-30.5%-57.82%-36.58%-54.82%
page 9
lowry order code ?
rodin order code ?
• Brogue bootee• Available in leather or nubuck• Lace or Velcro• Safe-seam construction
• Plain front bootee• Available in leather or nubuck• Lace or Velcro• Safe-seam construction
healix footwear
healix. a valuable lessen Reed Medical in partnership with Tekscan page 11
scott order code ?
stubbs order code ?
• Plain front 3 eyelet shoe• Available in leather or nubuck• Lace or Velcro• Safe-Seam construction
• Brogue 3 eyelet shoe• Available in leather or nubuck• Lace or Velcro• Safe-Seam construction
degas order code ?
• Plain front extended 4 eyelet shoe• Available in leather or nubuck• Lace or Velcro• Safe-Seam construction
healix footwear healix footwear
healix. a valuable lessen Reed Medical in partnership with Tekscan page 13
breton order code ?
hockney order code ?
• Brogue extended 4 eyelet shoe• Available in leather or nubuck• Lace or Velcro• Safe-Seam construction
• 5 eyelet trainer style shoe• Available in leather only• Lace or Velcro• Safe-Seam construction
healix footwear
monet order code ?
• Plain front extended 5 eyelet shoe• Available in leather or nubuck• Lace or Velcro• Safe-Seam construction
healix. a valuable lessen Reed Medical in partnership with Tekscan
hirst order code ?
fagan order code ?
• Plain front casual 4 eyelet shoe• Available in leather or nubuck• Lace or Velcro• Safe-Seam construction.
• Trainer boot.• Available in leather only• Lace or Velcro• Safe-Seam construction
healix footwear
zero g ankle foot orthosis (afo) order code ?
Technical Details
Sizing
The Zero G ankle foot orthosis (AFO) is a prefabricated, offloading brace that relieves plantar surface pressure from the foot. The Zero G AFO incorporates a supple, but strong, adjustable, calf corset with leather lacers and Velcro closures. This design provides a total-contact, hydrostatic lift of the inverted cone shapeof the calf, providing up to 100 per cent offloadingof the foot. The Zero G brace’s patented design,with malleable metal uprights, provides a sturdy,stable substructure that transfers weight from the ground top the calf and not the foot and ankle,providing up to 100 per cent non-weight bearing.
The Zero G AFO comes in two components,the calf lacer and the AFO base.
calf lacer• Apply with an adjustable Velcro closure system for ease of donning/doffing the brace• Anterior tongue protection to complete the 360-degree lacer• One Smartknit seam-free sock for soft interface• Infinitely adjustable leather corset on the brace structure with Velcro fasteners
afo base• Half inch donning pad to ensure a repeatable off-loading process• Double-action ankle joints for assist/resist adjustment• One inch memory foam foot pad to cushion any pressure applied to plantar surface of the foot• Footplate pad made from ¼” plastazote• Adjustable, padded foot cover encases and protects the foot• Universal for left or right fitting
Measurements of the calf circumference and the foot length and taken to determine proper sizing.The lacer and AFO Base sizes of the Zero G AFO can be interchanged for a correct fit.
calf lacerProduct Code Size Calf Circumference
ZGAL-100S Small 9.5-12.5”
ZGAL-100M Medium 13-15.5”
ZGAL-100L Large 19-22.5”
afo baseProduct Code Size Foot Length
ZGA-100S Small 8.19-9.02
ZGA-100M Medium 9.17-9.84
ZGA-100L Large 10.91-11.75
ZGA-100XL X-Large 10.91-11.75
ZGA-100XXL XX-Large 11.77-12.25
The Zero G AFO is indicated for the following conditions:
• Charcot foot (neuropathic joint disease)• Arthritis, including Gout/Gouty arthritis• Osteochondritis Dissecans• Heel and metatarsal ulceration • Diabetic foot ulcers • Fractures of the distal tibia, talus or calcaneous • Pre or post-surgical intervention of the mid and hind foot• Crushing injuries of the mid and hind foot• Any condition in which unweighting of the foot or ankle is needed
zero g footwear
page 15
fore foot off-loader universal fit for left or right foot order code PO100
forefoot and mid foot off-loader universal fit for left or right foot order code PO500
• Black only• Sizes 35 - 47• Low 34mm heel reduces leg length discrepancy trauma and maintains stability• Velcro fasten• Complete with dual density 8 degree negative pitch insole
• Black only• Sizes 35-47• Low 22mm sole• Velcro fasten• Rigid rocker• Complete with dual density 8 degree negative pitch insole
loadstars footwear
17 37 30 32 36
25 52 50 55 65 57 26
25 37 40 55 60 42
32 35 47 60 37
22 40 62 72 45
6740 80 55
5432 3267 62
4550 72 84 86 77
77 135 150 157 147 132 70
112 165190 192 182 160 92
127 152147167 92
ALLUX LESS. TOES
MED. FOREF
MID. FOOT
MED. HEEL AT. HEEL
AT. FOREF
42 62 67 80 65
62 82 95 110 115 92 40
27 27
27 57 72 100 105 95 82
15 42 70 80 67
25 57 70 50
15 55 75 52
30 47 55 22
22 60 70 65 65 15
47 142175 150 162 132 40
117 216240 250 240 219 87
127 212212 212 92
ALLUX LESS. TOES
MED. FOREF
MID. FOOT
MED. HEEL AT. HEEL
AT. FOREF
300.00
220.00
150.00
100.00
60.00
kPa
15.00
40.00
15.00
300.00
220.00
150.00
100.00
60.00
kPa
15.00
40.00
15.00
heel off-loader universal fit for left or right foot order code PO400
loadstars footwear
115 140 140 130 122 110 67
373737 45 60 67 62
85 90 80 82 8017 52
30 80 90 80 80 75 60
17 42 52 47 40
37 45 57 70 525057
5755 72 6230 5755
70 135 135 130 115 55 25
8247 25 2532 22 27
167 187 87275232
75 55 22
92 90 92 85 87 8052
626555 60 7215 42
ALLUX LESS. TOES
MED. FOREF
MID. FOOT
MED. HEEL AT. HEEL
AT. FOREF
115 140 140 130 122 110 67
373737 45 60 67 62
85 90 80 82 8017 52
30 80 90 80 80 75 60
17 42 52 47 40
37 45 57 70 525057
5755 72 6230 5755
70 135 135 130 115 55 25
8247 25 2532 22 27
167 187 87275232
75 55 22
92 90 92 85 87 8052
626555 60 7215 42
ALLUX LESS. TOES
MED. FOREF
MID. FOOT
MED. HEEL AT. HEEL
AT. FOREF
300.00
220.00
150.00
100.00
60.00
kPa
15.00
40.00
15.00
healix. a valuable lessen Reed Medical in partnership with Tekscan page 17
stability walker universal fit for left or right foot order code PO700
• Black only• Removable lateral stability inserts• Low friction upper• Rigid outsole with full rocker for steady mid stance• Dual density 8 degree negative pitch insole• Modus insole option (extra cost)• Velcro fasten• Sizes 35-47
Recommended for• Tibiotarsal, subastragaloid arthrodesis• Charcot foot• Corrective distal osteotomy• Calcaneal fractures• Mid foot and forefoot ulcers• Comparable to Gold Standard TCI’s
• Black only• Sizes S 35-36-37 M 38-39-40 L 41-42-43 XL 44-45-46-47• Removable heel protector• Soft PU insole• Velcro fasten
dual density 8 degree negative pitch insole universal fit for left or right foot order code ?
• Transfers pressure from the forefoot to the rearfoot• Sizes 35/36 37/38 39/40 41/42 43/44 45/46 47/48
loadstars insoles
healix. a valuable lessen Reed Medical in partnership with Tekscan
modus off loading insole universal fit for left or right foot order code ?
• Triple density insole with removable inserts for specific pressure reduction• Anti bacterial and antifungal properties• Ideal for plantar surface ulcer pressure relief • Sizes 35/36 37/38 39/40 41/42 43/44 45/46 47/48
