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    INTRODUCTION

    Foot ulcers in patient with DM precede 85%

    of all non-traumatic lower limb amputations

    Most plantar foot ulcers are caused by acombination of loss of protective sensation

    due to peripheral neuropathy, a complication

    of the disease, and elevated levels of

    mechanical stress as a result of change infoot structure

    Forefoot and toe region plantar ulcers>>

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    INTRODUCTION

    Mechanism ofFOS redistribution of load

    from forefoot to proximal regions by a rocker

    bottom outsole and a negative heel

    configuration

    The aim of this study was to assess the

    offloading efficacy of four different FOS

    models in comparison with cast shoe andcontrol shoe in a group of diabetic patients

    with peripheral neuropathy

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    Methods, subject

    24 neuropathic diabetic patients (20 men, 4

    women) at high risk for plantar foot

    ulceration

    The mean (SD) age, height, weight andbody-mass index of the subjects was 60.0

    (7.0) years, 1.72 (0.07) m, 92.0 (15.2) kg,

    and 30.9 (4.3) kg/m2

    5 patients had diabetes type 1, 19 patientstype 2

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    Methods, subject

    Loss of protective sensation due toneuropathy was confirmed by the inabilityto sense a 10-g SemmesWeinsteinmonofilament at one of the four plantar footsites tested (hallux, first and fifthmetatarsal head, and heel) or the inabilityto sense a vibration of 25 V at the great toeas measured with a Neurothesiometer

    (Horwell ScienticLaboratory Supplies,Wilford, Nottingham, UK).

    Each patient had at least one footdeformity

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    Methods, subject

    Excluded were patients with a current footulcer, inability to walk a distance of 20 mrepeatedly without walking aid, lower-extremityamputation, active neuro-osteoarthopathy or

    Charcot deformity, equinus foot deformity, andtreatment for serious medical conditions orinjuries other than diabetes mellitus that mayinterfere with lower limb function (walking).

    The study protocol was approved by the

    LocalResearch Ethics Committee and each subject

    gave written informed consent before the startof the study.

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    Methods, Footwear

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    Methods, data analysis Each foot was divided into six anatomical regions: heel,

    midfoot, first metatarsal heads, second-to-fifth metatarsalheads, hallux, and lesser toes. For each region, peak pressure,

    pressuretime integral (PTI), and forcetime integral (FTI) were

    calculated

    Load transfer was calculated between the offloading footwear

    and the control shoe.

    Statistical analysis was using SPSS (Version 14.0)

    For all normally distributed data ANOVA

    Bonferroni post hoc testing was used for multiple pairwise

    comparisons between footwear conditions. For data that was not normally distributed Wilcoxon signed-

    rank test

    A significance level of P < 0.05 was adopted for all analyses.

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    Result

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    Result

    Fig. 2. Load transfer diagrams showing the mean regional differences and inter-

    regional load transfer in normalized FTI between each of the five offloading

    footwear conditions and the control shoe. Diagram A, Thanner Cabrio FOS; B,

    RattenhuberTalus FOS; C, Fior&Gentz HannoverFOS; D, Fior&Gentz Luneburg

    FOS; and E, Mabal cast shoe. The breadth of the arrows is proportional to the

    absolute amount of load transfer. MTH; metatarsal heads.

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    Result

    Perceived walking comfort varied

    substantially between footwear

    conditions with the control shoe

    perceived as most comfortable (VAS

    score 8.2) and the Fior&Gentz Luneburg

    shoe as least comfortable shoe (VAS

    score 2.7)

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    Discussion

    The results of this study show that the fourFOS modelstested were effective in offloading the forefoot in at-riskneuropathic diabetic patients.

    Substantial reductions in peak pressure compared to acontrol shoe were achieved in the regions where mostfrequently ulcers develop: 5158% at the metatarsal headsand 3849% at the hallux. Significant reductions in theseregions were also found for the PTIs.

    All fourFOS models tested were equally effective inoffloading the forefoot, with small differences present

    between the different models in most foot regions. Thepeak pressure reductions found in this study are of thesame magnitude as those reported in an earlier study of agroup of ulcer patients tested in several offloading devices,including a similar type FOS

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    Discussion

    Significant differences in metatarsal head peak pressuresfound between the FOS and Mabal cast shoe were notmimicked by differences in metatarsal head PTIs. PTI isdefined by the area under the peak pressure time curve.Apparently, longer contact times or more flattened and

    broader peak pressure curves at these regions in the FOSexplained this difference in pattern between peak pressureand PTI results

    The mechanism of action of the FOS, as assessed usingthe load transfer diagrams shown in Fig. 2, was clearly alarge transfer of load from the forefoot to the midfootregion. On average 40% of the total force impulse presentin the forefoot and toe regions was transferred to proximalfoot regions

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    Discussion

    The load transfer diagrams also show

    that only small portions of load were

    transferred from the midfoot to the heel

    in the offloading footwear.

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    Discussion

    All FOS models were perceived as

    significantly less comfortable to walk in

    when compared with the control shoe and

    the Mabal cast shoe. Most likely, the designfeatures of the FOS that caused substantial

    pressure relief in the forefoot were also

    responsible for more walking discomfort in

    this group of patients who already havesensory loss in their feet and therefore

    more difficulty with walking

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    Discussion

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    Conclusions

    The data showed that all FOS models were

    effective in their primary goal, relieving

    forefoot pressure in at-risk neuropathic

    diabetic patients.

    Therefore, these shoes may be effective in

    offloading and healing plantar forefoot ulcers,

    although the low comfort scores should beconsidered as this may potentially affect

    adherence to treatment

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