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. www.diabeticfoot.nl Page 1 of 11 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. www.diabeticfoot.nl Page 2 of 11 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 www.diabeticfoot.nl Page 3 of 11 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 www.diabeticfoot.nl Page 4 of 11 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 www.diabeticfoot.nl Page 5 of 11 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 www.diabeticfoot.nl Page 6 of 11 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. www.diabeticfoot.nl Page 7 of 11 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. www.diabeticfoot.nl Page 8 of 11 Figure 1. Average plantar peak pressures: a. TCC (right foot), b. Walker (right foot), c. Shoes with insoles (left and right foot). www.diabeticfoot.nl Page 9 of 11 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 www.diabeticfoot.nl Page 10 of 11 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 www.diabeticfoot.nl Page 11 of 11
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