Poster session 13: Offloading (shoes)
P13.01
Preliminary investigation of an exercise program utilizing an offloading bicycle cleat
in diabetic foot ulcer patients
Ryan Crews, Rosalind Franklin University, North Chicago, IL, United States
Jeffrey Lin, Rosalind Franklin University, North Chicago, IL, United States
Erin Klein, Rosalind Franklin University, North Chicago, IL, United States
Sai Yalla, Rosalind Franklin University, North Chicago, IL, United States
Aim: As most forms of exercise induce physical stress upon the feet, diabetic foot ulcer
(DFU) patients typically minimize their physical activity. This “prescribed” inactivity
challenges patients’ ability to control their diabetes and increases their risk of additional
complications. The aim of this study was to preliminarily evaluate an exercise program
utilizing an offloading bicycle cleat for individuals with DFU.
Methods: Ten subjects will exercise 3 times weekly for 4 weeks on a recumbent stationary
bicycle using the offloading cleat with their DFU foot. Exercise intensity was prescribed via
age predicted heart rate, and each successive week required greater intensity. Offloading of
DFU was confirmed via plantar pressure assessment at the first visit of each week. Subjects
evaluated the exercise program weekly via a Likert scale questionnaire scored from 0 (bad)
to 25 (good). Hemoglobin A1c (HbA1c) and quality of life (NeuroQoL) were measured at
screening and end of study.
Results: Two subjects have completed the trial to date. The first completed 92% of
scheduled visits. His exercise questionnaire was 19 at baseline and 21 at end of study. The
second subject completed 100% of scheduled visits. Her exercise questionnaire was 25 at
baseline and 23 at end of study. Plantar pressure during cycling never exceeded that
observed when either subject walked in their designated offloading modality., HbA1c
decreased from 10.5 to 10.1% in subject 1 and decreased from 6.9 to 6.6% in subject 2.
Several of the NeuroQol domains improved in each subject, however, both saw increased
pain at end of study.
Conclusions: This preliminary investigation of the offloading bicycle cleat exercise program
has shown promise for patients with active DFU. Both subjects that have been enrolled
found the program amenable and exhibited numerous improvements in outcome measures.
Previous research had demonstrated the capacity of the cleat to offload users’ forefeet;
however, this is the first investigation of routine use of the device. This protocol’s design was
somewhat short for an exercise intervention, however, the serious nature of DFU has
necessitated a careful progression of this research. Positive results from this study will
support the conduct of a larger and longer study.
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P13.02
Forefoot offloading shoes impact
Roberto Da Ros, Monfalcone Hospital, Monfalcone, Italy
Federica Spada, Podartis Research Center, Montebelluna, Italy
Silvana Carlucci, Monfalcone Hospital, Monfalcone, Italy
Roberta Assaloni, Monfalcone Hospital, Monfalcone, Italy
Barbara Brunato, Monfalcone Hospital, Monfalcone, Italy
Carla Tortul, Monfalcone Hospital, Monfalcone, Italy
It is known that increased plantar foot pressure is a leading cause of ulceration in diabetic
population. Offloading is one fundamental means to heal. Forefoot offloading shoes are
commonly used in clinical practice for treatment of plantar forefoot ulcers. Guidelines
underline that half shoes can be effective in the treatment of plantar ulcer but few data are
available on effective load reduction.
Aim of the study: to evaluate offloading efficacy of two forefoot offloading shoes, WPS half
shoe (Podartis) and Teradiab (Podartis), compared to normal shoe in diabetic patients., In
addiction to analyse transfer of load in contralateral foot and comfort of the patients.
Materials and methods: 13 diabetic patients with lesions of forefoot were enrolled in the
study. We applied a system of insole with pressure detector (Pedar system, Novel) inserted
between foot and insole. We evaluated plantar pressure during three walking test (not
ulcerated foot maintain normal shoe): first with normal shoe in both feet, second with WPS in
ulcerated foot, third with Teradiad (a temporary shoe with rigid sole and zero insole a
particular insole that permit forefoot dorsiflexion). We measured, peak pressure during
walking, calculate mean pressure in the contralateral foot, evaluate comfort with a visual
analogue scale.,
Results: analysis of peak pressure demonstrate that WPS compared to a normal shoe
reduced significantly forefoot pressure of 60% (from 291 to 116 kPa, p=0.01). Teradiab with
zero insole reduced significantly peak pressure of 47% compared to a normal shoe (from
291 to 154 kPa, p=0.04). Difference in reduction of peak pressure between WPS and
Teradiab was not significantly different (116 ws 154 kPa, p= 0.3). The three different shoes
not demonstrate a difference in contralateral foot mean load (123 normal shoe, 123 teradiab,
128 WPS). Analysis of perceived walking comfort was significantly higher with Teradiab than
with WPS.
Conclusion: WPS and Teradiab represents a valid opportunity for the offloading of forefoot
lesions, with an important reduction of forefoot peak pressure. They were well tolerated
without important transfer of load on contralateral foot. Teradiab presented better walking
comfort compared to WPS probably due to less postural discrepancy.
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P13.03
Partial foot amputatie: what is the challenge?
Clemens Rommers, University Hospital Maastricht, Maastricht, Netherlands
Barbara Engelen-Schouten, University Hospital Maastricht, Maastricht, Netherlands
Hans Emmen, Smeets Loopcomfort, Sittard, Netherlands
Ronald Sleegers, University Hospital Maastricht, Maastricht, Netherlands
Martijn Dremmen, University Hospital Maastricht, Maastricht, Netherlands
Nicolaas Schaper, University Hospital Maastricht, Maastricht, Netherlands
Aim: The aim of this audit was to determine the recurrence rate of a diabetic foot ulcer
(DFU) after a partial foot amputation when high shaft shoes with rigid counterfort and rocker
bar, guided by in shoe-plantar pressure measurements (Pedar-X ®), are prescribed.
Methods: Patients with a recent partial foot amputation because of a DFU in 2011-2014, and
treated by our multidisciplinary team were identified and their electronic records reviewed. All
patients were prescribed therapeutic footwear with the aim to reduce peak plantar foot
pressure below 250 kPa. The ulcer free period was calculated as the time between shoe
prescription and recurrence of a DFU.
Results: Nineteen diabetic patients with a recent partial foot amputation were included., The
mean duration of diabetes was 22 years; 32% were female with a mean age of 63 years.
The level of amputation varied between a ray and a Chopart amputation. The post-operative
pressure measurements suggested that especially the more proximal amputations were
adequately offloaded by the prescribed shoe-wear. All patients had a recurrent ulcer during a
mean duration of follow-up of 20 months, with a mean ulcer free period of 166 days. One
patient had a transtibial amputation.
Discussion: The results of pressure guided prescription of therapeutic footwear after a
partial foot amputation were disappointing given the relative short ulcer free period. We did
not measure compliance in wearing the prescribed shoes, but several patients informed us
that they were incompliant.
Conclusion: Further research is needed on to guide amputation level selection in an
individual patient, to improve off-loading of the therapeutic shoes and in particular to develop
strategies to improve compliance.
From amputation to orthopaedic shoe
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P13.04
A prospective analysis of the shoe fitting service provided as a part of a specialist
MDT foot clinic
Catherine Gooday, Norfolk and Norwich University Hospitals NHS Foundation Trust,
Norwich, United Kingdom
Kevin Panter, Ken Hall Ltd, Kettering, United Kingdom
Ketan Dhatariya, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich,
United Kingdom
Aim: Ill-fitting footwear is recognised as a leading cause of ulceration. Hospital footwear is
an expensive intervention. We aimed to analyse the type of patients referred for footwear,
manufacture times, fit & comfort of the shoes & proportion of patients who attend for follow
up
Method: All new patients referred from the diabetic foot clinic to the footwear service were
recorded between 2011 & 2014. Data was collected on all 153 new referrals. At baseline the
most serious reason for referral was recorded
Results; Average age was 69.4 years (±SD12.6), M:F 109/44. The most common reasons
for referral were - history of foot ulceration (n= 47); neuropathy & deformity (44), amputation
(44) & Charcot deformity (16). Patients were issued with footwear based on the degree of
deformity., 21.6% patients were issued with ‘stock’ shoes, 42% modified ‘stock’, & 33.9%
‘bespoke’ shoes. 1.9% required insoles alone. The average time from 1st appointment to
issue of the footwear was 9 weeks, (range 3-20). 28% of shoes were issued at 1st fitting
within 4-5 weeks & 57% of patients requiring a 2nd or 3rd clinic assessment to ensure the
shoes fitted correctly. The patients were reviewed by the shoe fitter 4-6 weeks after the
footwear was issued. At this appointment the shoes were assessed for fit & comfort. In
74.5% of cases the shoes had not caused any problems, in 10% of cases the shoes had to
be modified, 1 patient developed an ulcer, which healed once the shoe was modified &
14.3% of patients were lost to follow up without further clinic attendances., The patients who
returned to clinic were ask to grade the comfort of the shoes from 1-6, 6 being extremely
comfortable & 1 very uncomfortable., 48 people graded the footwear as ‘6’; 63 people rated
it as a ‘5’; 19 people rated the shoes as ‘4’, & 1 person rated them as a ‘1’
Conclusions; this analysis has shown that the footwear provided in our clinic is a good fit
with few problems. Patients found the shoes acceptable, with 89% returning to be provided
with a 2nd pair. However 11% of patients were lost to follow-up; this might be because of
problems with fit, appearance or a lack of understanding of the importance of this footwear &
requires further analysis. It is an area that needs further health economic analysis
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P13.05
Mass customized protective footwear for patients with foot deformity: does it really
fit?
Simona Ferjan, University Medical Centre Ljubljana, Ljubljana, Slovenia
Mira Slak, University Medical Centre, Ljubljana, Slovenia
Vilma Urbancic, University Medical Centre, Ljubljana, Slovenia
Aim: Foot deformities (claw toes, hallux valgus) are common in patients with diabetes and in
general population, especially in the elderly (1, 2)., The suitability of mass-customized
protective footwear from serial production is questionable since the shape of shoe mould is
defined solely by the manufacturer and widely differs between manufacturers (3). The aim of
the study was to collect the data on foot dimensions and the prevalence of foot deformity in
the patients with diabetes and in general population and assess the suitability of mass
customized protective footwear.
Methods: 488 feet, of 244 adult patients with diabetes (D) without open foot ulcer, previous
amputation or Charcot osteoarthropathy and 627 feet of 314 controls (C, customers from the
shoe-store) were included. Foot scanning was performed with 3D laser scanner, creating a
3D model of the leg with an accuracy of 1mm (4). The following parameters were analyzed:
foot width and circumference at the MTF region, height (the highest point in the toes
section), clawing (angle bounded by the slope of the toes to the ground), hallux valgus
(angle between the medial line of the first toe and the axis of the leg). The foot dimensions
obtained by scanning were compared with the dimensions of the mass customized trekking
shoe, advertised as protective, footwear.
Results: 89 (18.2%) D feet and 99 (15.8%) C feet had claw toes, 73 (15%) D and 94 (15%)
C had hallux valgus, 35 (7%) D and 19 (3%) C had both deformities. The dimensions of the
foot and shoe were matching in 14 D (3%) and 113 C (18%). 471 D (96.5%) and 490 C
(78%) had broader feet than the shoes of the according length size. In 137 D (28%) and 244
C (39%) the height of the toes was greater than the height of the shoe. 37 D (8%) and 51 C
(8%), had longer, 18 D (3%) and 15 C (2%) had higher feet than the maximum shoe-lasts.
Conclusions: Mass-customized footwear does not match the shape of the feet neither by
width nor by toe-height. Since foot deformity is common both in patients with diabetes and in
general population, production of extra-wide shoes with more toe space could be
economically viable.
References
1. Paiva de Castro A, J Sport Rehabil. 2010;19(2):214-25
2. Mansour AA, Perm J. 2008;12(4):25-30
3. Janisse DJ, Foot Ankle. 1992;13(5):257-62
4. Novak B, SV-JME 2014; 60(11): 685-693
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P13.06
Data-driven directions for effective footwear provision for high-risk diabetic patients
Sicco Bus, Academic Medical Center, University of Amsterdam,Amsterdam-, Netherlands
Mark Arts, Academic Medical Center, Amsterdam, Netherlands
Mirjam de Haart, Academic Medical Center, Amsterdam, Netherlands
Roelof Waaijman, Academic Medical Center, Amsterdam, Netherlands
Rutger Dahmen, Slotervaart Hospital, Amsterdam, Netherlands
Heleen Berendsen, Reinier de Graaf Gasthuis, Delft, Netherlands
Frans Nollet, Academic Medical Center, Amsterdam, Netherlands
Patients with diabetes mellitus who are at high risk for developing a foot ulcer on the plantar
surface of the foot are often offloaded with custom-made footwear to prevent these ulcers.
This footwear is however suboptimal in relieving plantar foot pressure (1). The aim of this
study was to evaluate the offloading effectiveness of modifying custom-made footwear and
aimed to provide directions for effective footwear provision.
Eighty-five neuropathic diabetic patients with a recently healed plantar foot ulcer, who
participated in a multi-centre randomized trial on footwear effectiveness, were provided with
new custom-made footwear. This footwear, and any other pair of custom-made footwear the
patient had, were evaluated with in-shoe pressure measurements at three-monthly intervals
for 15 months or until a foot ulcer developed, and the footwear was modified when peak
pressure at plantar regions was ≥200kPa. The effect of single and combined footwear
modifications on in-shoe peak pressure at these high-pressure target locations and at 8
anatomical foot regions was assessed and then summarized in an offloading-effect matrix.
Footwear modifications were freely chosen by the shoe technician.
All footwear modifications significantly reduced peak pressure at the target locations (range
in peak pressure relief: -6.7% to -24.0%, p<0.05), which were mostly located at the
metatarsal heads. Repositioning a metatarsal pad or trans-metatarsal bar in the insole (15.9% peak pressure relief), applying local cushioning to the insole (-15.0%), and replacing
the top cover of the insole (-14.2%), were the most effective single modifications. Combining
the latter with a trans-metatarsal bar (-24.0%) or with local cushioning (-22.0%) were the
most effective combined modifications.
In diabetic patients with a recently healed plantar foot ulcer, significant offloading can be
achieved at high-risk foot regions by modifying the custom-made footwear that these
patients wear to protect their feet against pressure-related ulcers. These results provide
data-driven directions for effective offloading to be used in custom-made footwear design
and evaluation for diabetic patients.
(1) Arts ML et al. (2012). Diabet.Med 29: 1534-1541
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P13.07
Rocker soles for the diabetic foot: What does current research demonstrate?
Dennis Janisse, Medical College of Wisconsin, Milwaukee, United States
Aim: This abstract is a literature review and review of current practice regarding the use of
rocker soles for management of the diabetic foot.
Methods: Published articles were reviewed with the most attention paid to the most recently
published material., Keywords searched for included: rocker soles, offloading, shoes,
footwear, shoe modifications, diabetic foot, diabetes, neuropathy, partial foot amputation,
plantar pressure distribution.
Results: There is significant data that demonstrate the usefulness and efficacy of rocker
soles for offloading the forefoot and helping to reduce peak plantar pressures in the foot., A
number of studies looked at what the minimum recommendations should be and therefore
examined the mechanics of an off-the-shelf shoe with a minimal rocker sole design already
built in to the design of the shoe., It was repeatedly shown that even a minimal rocker sole is
helpful in reducing forefoot pressures.
Conclusions: Many clinicians prescribe custom foot orthoses, custom shoes and in-depth
shoes to manage patients with diabetic neuropathy., Shoe modifications such as rocker
soles are too often overlooked., They may be ignored because the clinician is unfamiliar with
them or because of the additional cost incurred, albeit typically nominal., Other reasons for
their disuse may include aesthetic concerns or the disinclination of the pedorthist or orthotist
to take the extra time to modify the shoes with a rocker sole., Whatever the reason, rocker
soles are a valuable tool and can be used to tremendous effect in reducing forefoot
pressures, normalizing gait, improving function, restoring lost motion and minimizing
recurrences of diabetic foot ulcers.
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P13.08
Can shoes with insoles offload ulcers as effectively as total contact casts and
walkers? A case study
Gustav Jarl, Örebro University, Örebro, Sweden
Roy Tranberg, University of Gothenburg, Gothenburg, Sweden
Aim: To investigate if a shoe with an adjusted insole can off-load a metatarsal head (MTH)
ulcer as effectively as a total contact cast (TCC) or a walker without inducing excessive
pressures on the rest of the foot.
Methods: Case: a 59-year old man with diabetes type 2, neuropathy, a weight of 120 kg and
a healed ulcer on MTH 4. The plantar pressures were measured (F-scan, Tekscan, MA,
USA) while the subject walked 3 times in a self-selected speed over a level surface under 3
conditions:
1. TCC made of Scotchcast (3M, MN, USA) and padded with 2 and 5 layers of cotton wool
on the shank and foot, respectively.
2. Walker (XP Diabetic Walker, DJO Nordic, Sweden) with insole.
3. Shoe (extra-depth, rocker-bottom sandal; Tärnan, Sweden) with adjusted insole.
The insole (conditions 2 and 3) was custom-made after a foam imprint and made of 2-layer
ethylene-vinyl acetate with a hardness of 50 and 20 Shore, respectively. The top surface
was then covered with a 3 mm layer of microcellular urethane. In condition 3 the insole was
adjusted on the location of the ulcer by grinded it from the underside until the urethane layer
was exposed.
Results: Compared to the TCC and the walker the average plantar peak pressures in the
shoe were lower on the MTH 4 ulcer but higher on the medial MTH:s and hallux (Figure 1).
In general, the pressures when wearing shoes were lower on the right foot than on the nonulcerated left foot.
Conclusions: This case study suggests that a shoe with an individually adjusted insole in
some cases might be more effective than a TCC or walker to off-load a single MTH ulcer.
Although the shoe and insole come with higher pressures on the medial forefoot, the
pressures do not seem to reach excessive levels.
Acknowledgements
Örebro County Council supported this study.
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Figure 1. Average plantar peak pressures: a. TCC (right foot), b. Walker (right foot), c. Shoes
with insoles (left and right foot).
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P13.09
A quick method to make individually shoes for severe diabetic foot-ulcers and for
partially amputations – combined with 80% saving of costs
Bent Nielsen, Klinik for Fodterapi, Stenlose, Denmark
Aim: To get optimized healing of severe diabetic foot ulcers by making 100% individually
shoes – while achieving financial savings of 80%. The goal is also making the shoes flexible
for adjustments during the healing period.
Methods: After doing analyses of weight bearing areas of the foot, location of ulcers, joint
movements, gait-pattern etc. you do measurements of the foot. Then using some
thermoplastic materials used in the podiatric clinic as well by hand-shoemakers and surgical
appliance maker to design and produce the shoe.
Depending of the conditions of the patient different materials can be used: Very rigid, semirigid or soft or a mix to achieve the wanted gait-pattern and gait-function.
Equipment for the process:
You only need scalpels, a grinding machine and suction-chamber for vapours from the glue,
like for making insoles. The pieces of materials only have to be glued together to achieve the
shape, function, protection and the pressure offloading you want. Method is illustrated by a
video.
Results: By this flexible method you can make shoes in around 1 hour for the most typically
foot ulcers seen at diabetic patients. For more sophistically and complicates models you
need up to 2½ hour to have out of bed and walking out the clinic or hospital to be an
outpatient. Patient is walking immediately and few hours after operation in the foot.
Conclusions: The method for making shoes used temporarily in the healing period for
ulcers, amputations and severe disorders of the skeleton bones is quick and simple. It don`t
need any complicated or expensive equipment. There are no limits for correcting the shoes if
necessarily during the period of treatment. This low technologically method is also suitable in
countries with limited resources and equipment
Unsuccessful healing after 8 operations. Then planned
amputation, but by using the shoe the wound healed totally
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P13.10
Postural instability evaluation as an early indicator of polyneuropathy might lead to
efficient podiatric symptomatic treatment
Alban Lebarillier, CHR Citadelle, Liège, Belgium
Patricia Felix, CHR Citadelle, Liège, Belgium
Aim: Evaluation of postural instability as an early symptom of neuropathy and the potential
positive effect of specific insoles.
Methods: Postural instability is subjectively very frequent in diabetic and prediabetic
patients, associated to neuropathy and responsible of many trauma by falling. Litterature
describes this fact since 2000. This work has for purpose to review definition, status and
consequences of abnormal proprioception and to suggest a new approach of imbalance by
combined methods based on posturology and an experimental insole since previous use of
classical "orthopedic insoles" or soft insoles usually lead to negative clinical effect on
stability.
CLINICAL CASE of 45 year old woman with longlasting type 1 diabetes presenting major
subjective postural instability diagnosed as severe evolutive neuropathy with ataxia.Physical
treatment had little positive result. Neurological testing reveals disturbance of thermo-algesic
sensitivity and QOL scale 2/10.Posturological treatment leads to QOL 8/10.Table 1 explains
measurements observed.
Results: measurements before and after treatment show normalization of 4 of 6 criteria for
instability.Those values persist after 2 weeks. Postural insoles maintain well-being and QOL.
Conclusions: Postural instability is a frequent aspect of early neuropathy in diabetes and
pre-diabetes and should be investigated by a specialized podiatrist if impairing daily life.
Posturology is a practical way to predict efficiency of specific insoles, as classical methods
tend to emphasize discomfort.As postural instability might appear long before classical
symptomatic neuropathy, this different and new approach may help in handling diabetes as
a whole.
Instability measurements before and after postural treatment
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