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Quality improvement depends on data collection and audit of clinical services to inform clinical improvements. Various steps in the care of the diabetic foot can be used to audit a service but need defined audit standards. A diabetes foot service should have risk stratification system in place that should compare to the population-based figures of 76% having low-risk feet, 17% moderate risk and 7% being at high risk of ulceration. Resources can then be directed towards those with high-risk feet. Prevalence of foot ulceration needs to be audited. Community-based studies give an audit standard of around 2%, with 2 to 9% having had an ulcer at some stage in the past. Amputation rates should be easier to measure, and the best results are reported to be around 1.5-3 per 1000 people with diabetes. This is a useful benchmark figure, and the rate has been shown to decrease by approximately a third over the last 15 years in some centres. Ulceration rates and ulcer healing rates are the ultimate outcome audit measure as they are always undesirable, whilst occasionally for defined individuals, an amputation can be a good outcome. In addition to clinical outcomes, processes of care can be audited such as provision of clinical services, time from new ulcer to be seen by health care professional, inpatient foot care or use of antibiotics. Measurement of clinical services can be a challenge in the diabetic foot, but it is essential if clinical services and patient outcomes are to be improved., (Copyright © 2016 John Wiley & Sons, Ltd.)

Symptoms or signs of peripheral artery disease (PAD) can be observed in up to 50% of the patients with a diabetic foot ulcer and is a risk factor for poor healing and amputation. In 2012, a multidisciplinary working group of the International Working Group on the Diabetic Foot published a systematic review on the effectiveness of revascularization of the ulcerated foot in patients with diabetes and PAD. This publication is an update of this review and now includes the results of a systematic search for therapies to revascularize the ulcerated foot in patients with diabetes and PAD from 1980 to June 2014. Only clinically relevant outcomes were assessed. The research conformed to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, and Scottish Intercollegiate Guidelines Network methodological scores were assigned. A total of 56 articles were eligible for full-text review. There were no randomized controlled trials, but there were four nonrandomized studies with a control group. The major outcomes following endovascular or open bypass surgery were broadly similar among the studies. Following open surgery, the 1-year limb salvage rates were a median of 85% (interquartile range of 80-90%), and following endovascular revascularization, these rates were 78% (70-89%). At 1-year follow-up, 60% or more of ulcers had healed following revascularization with either open bypass surgery or endovascular techniques. Studies appeared to demonstrate improved rates of limb salvage associated with revascularization compared with the results of conservatively treated patients in the literature. There were insufficient data to recommend one method of revascularization over another. There is a real need for standardized reporting of baseline demographic data, severity of disease and outcome reporting in this group of patients., (Copyright © 2015 John Wiley & Sons, Ltd.)

Many patients with wound healing difficulties are also coping with the management of a chronic disease or chronic condition that requires them to make lifestyle behaviour changes, for example, managing glucose levels through diet and exercise and regular foot inspection. Many find it difficult to make such changes and often experience feelings of powerlessness when faced with a lifetime of behavioural and psychological change. This article will explore the importance of understanding the patient difficulties associated with adherence to a regime and how life changes can be difficult to maintain over sustained periods of time. However, the article will also discuss the importance of this topic in trying to understand the clinical evidence base for treatment--as many clinical trials investigating treatments for the diabetic foot do not include information on the extent to which patients in the trial conformed to the trial protocol. The article gives an overview of recent developments--including lessons we can learn from other chronic conditions where permanent life changes are required--in particular the need to keep health messages simple, tailored to the individual and repeated frequently. The evidence to date suggests that no one single form of adherence intervention will work with all patients; this is not surprising given complex and multifactorial nature of adherence and the myriad of barriers that exist that patients and health care professionals need to overcome., (Copyright © 2016 John Wiley & Sons, Ltd.)

Background: Charcot neuroarthropathy (CN) of the ankle and hindfoot (Sanders/Frykberg Type IV) is challenging to treat surgically or nonsurgically. The deformities associated with ankle/hindfoot CN are often multiplanar, resulting in sagittal, frontal and rotational malalignment. In addition, shortening of the limb often occurs from collapse of the distal tibia, talus and calcaneus. These deformities also result in significant alterations in the biomechanics of the foot. For example, a varus ankle/hindfoot results in increased lateral column plantar pressure of the foot, predisposing the patient to lateral foot ulceration. Collapse of the talus, secondary to avascular necrosis or neuropathic fracture, further accentuates these deformities and contributes to a limb-length inequality., Surgical Management: The primary indication for surgical reconstruction is a nonbraceable deformity associated with instability. Other indications include impending ulceration, inability to heal an ulcer, recurrent ulcers, presence of osteomyelitis and/or significant pain. Arthrodesis of the ankle and/or hindfoot is the method of choice when surgically correcting CN deformities in this region. The choice of fixation (i.e. internal or external fixation) depends on largely on the presence or absence of active infection and bone quality., Conclusion: Surgical reconstruction of ankle and hindfoot CN is associated with a high rate of infectious and noninfectious complications. Despite this high complication rate, surgeons embarking on surgical reconstruction of ankle and hindfoot CN should strive for limb salvage rates approximating 90%. Preoperative measures that can improve outcomes include assessment of vascular status, optimization of glycemic control, correction of vitamin D deficiency and cessation of tobacco use., (Copyright © 2016 John Wiley & Sons, Ltd.)

Background: Footwear and offloading techniques are commonly used in clinical practice for preventing and healing of foot ulcers in persons with diabetes. The goal of this systematic review is to assess the medical scientific literature on this topic to better inform clinical practice about effective treatment., Methods: We searched the medical scientific literature indexed in PubMed, EMBASE, CINAHL, and the Cochrane database for original research studies published since 1 May 2006 related to four groups of interventions: (1) casting; (2) footwear; (3) surgical offloading; and (4) other offloading interventions. Primary outcomes were ulcer prevention, ulcer healing, and pressure reduction. We reviewed both controlled and non-controlled studies. Controlled studies were assessed for methodological quality, and extracted key data was presented in evidence and risk of bias tables. Uncontrolled studies were assessed and summarized on a narrative basis. Outcomes are presented and discussed in conjunction with data from our previous systematic review covering the literature from before 1 May 2006., Results: We included two systematic reviews and meta-analyses, 32 randomized controlled trials, 15 other controlled studies, and another 127 non-controlled studies. Several randomized controlled trials with low risk of bias show the efficacy of therapeutic footwear that demonstrates to relief plantar pressure and is worn by the patient, in the prevention of plantar foot ulcer recurrence. Two meta-analyses show non-removable offloading to be more effective than removable offloading for healing plantar neuropathic forefoot ulcers. Due to the limited number of controlled studies, clear evidence on the efficacy of surgical offloading and felted foam is not yet available. Interestingly, surgical offloading seems more effective in preventing than in healing ulcers. A number of controlled and uncontrolled studies show that plantar pressure can be reduced by several conservative and surgical approaches., Conclusions: Sufficient evidence of good quality supports the use of non-removable offloading to heal plantar neuropathic forefoot ulcers and therapeutic footwear with demonstrated pressure relief that is worn by the patient to prevent plantar foot ulcer recurrence. The evidence base to support the use of other offloading interventions is still limited and of variable quality. The evidence for the use of interventions to prevent a first foot ulcer or heal ischemic, infected, non-plantar, or proximal foot ulcers is practically non-existent. High-quality controlled studies are needed in these areas., (Copyright © 2015 John Wiley & Sons, Ltd.)

Diabetic polyneuropathy is an insidious and long-term complication of this disease. Synergistic treatments and preventive actions are crucial because there are no clear boundaries for determining when health professionals should intervene or what intervention would best avoid the consequences of neuropathy. Until now, most therapies to any diabetic individual were applied only after the patient's limb was ulcerated or amputated. The loss of muscle and joint functions is recognized as the main cause of plantar overloading. However, if foot and ankle exercises are performed following the early diagnosis of diabetes, they can enable the patient to maintain sufficient residual function to interact with the environment. This article summarizes the current knowledge about the musculoskeletal deficits and biomechanical alterations caused by neuropathy. It also describes the potential benefits of foot and ankle exercises for any diabetic patient that is not undergoing the plantar ulcer healing process. We concentrate on the prevention of the long-term deficits of neuropathy. We also discuss the main strategies and protocols of therapeutic exercises for joints and muscles with deficits, which are applicable to all diabetic patients with mild to moderate neuropathy. We describe further efforts in exploiting the applicability of assistive technologies to improve the adherence to an exercise program. Following the contemporary trends towards self-monitoring and self-care, we developed a software to monitor and promote personalized exercises with the aim of improving autonomous performance in daily living tasks. Initiatives to prevent the complications of functional diabetes are highly recommended before it is too late for the patient and there is no longer an opportunity to reverse the tragic consequences of neuropathy progression., (Copyright © 2016 John Wiley & Sons, Ltd.)

The outcome of management of diabetic foot ulcers remains a challenge, and there remains continuing uncertainty concerning optimal approaches to management. It is for these reasons that in 2008 and 2012, the International Working Group of the Diabetic Foot (IWGDF) working group on wound healing published systematic reviews of the evidence to inform protocols for routine care and to highlight areas, which should be considered for further study. The same working group has now updated this review by considering papers on the interventions to improve the healing of chronic ulcers published between June 2010 and June 2014. Methodological quality of selected studies was independently assessed by two reviewers using Scottish Intercollegiate Guidelines Network criteria. Selected studies fell into the following ten categories: sharp debridement and wound bed preparation with larvae or hydrotherapy; wound bed preparation using antiseptics, applications and dressing products; resection of the chronic wound; oxygen and other gases, compression or negative pressure therapy; products designed to correct aspects of wound biochemistry and cell biology associated with impaired wound healing; application of cells, including platelets and stem cells; bioengineered skin and skin grafts; electrical, electromagnetic, lasers, shockwaves and ultrasound and other systemic therapies, which did not fit in the aforementioned categories. Heterogeneity of studies prevented pooled analysis of results. Of the 2161 papers identified, 30 were selected for grading following full text review. The present report is an update of the earlier IWGDF systematic reviews, and the conclusion is similar: that with the possible exception of negative pressure wound therapy in post-operative wounds, there is little published evidence to justify the use of newer therapies. Analysis of the evidence continues to present difficulties in this field as controlled studies remain few and the majority continue to be of poor methodological quality., (Copyright © 2015 John Wiley & Sons, Ltd.)

General principles of treatment in patients, suffering diabetic foot syndrome, are adduced. There was proved, that reconvalescence of the patients depends not only on quality of complex treatment, but from optimal choice of anesthesia method, its impact on postoperative period course. Application of prolonged blockade of n. ischiadicus gives possibility to perform operative intervention on the lower extremity in full volume, guarantees sufficient motor and sensory block, permits patients to reject from application of narcotic analgetics, to reduce the dose of strong nonnarcotic analgetics, the terms of transition of the wound process phase I into phase II, promotes early activization of patients postoperatively, constitutes alternative for other methods of anesthesiological support.

Complex service for treatment for patients, suffering diabetic foot syndrome, was created on the base of Dnipropetrovskiy Regional Clinical Hospital with the objective for application of high technologies. Creation of such a service have permitted to improve the results of the patients treatment. Enhancement of the performance rate of small operations on the foot have permitted to increase by 34.4% the quantity of patients, in whom a supportive function of the foot was preserved, and to reduce the conduction rate of the lower extremity amputation on a hip level, preserving a knee joint, by 39.5%, what is very important for the prosthesis. Widespread propaganda among population and primary link of the health service permit to reveal and eliminate complications of diabetes mellitus on earlier stages.

Objective: To evaluate the practice of off-loading diabetic foot ulcers (DFUs) using real-world data from a large wound registry to better identify and understand the gap between evidence and practice., Design: Retrospective, deidentified data were extracted from the US Wound Registry based on patient/wound characteristics, procedures performed, and at which clinic the DFU was treated., Setting: 96 clinics (23 from the United States and Puerto Rico), Patients: : 11,784 patients; 25,114 DFUs, Main Outcome Measures: : Healed/not healed, amputated, percent off-loading, percent use of total contact casting (TCC), infection rate, Main Results: : Off-loading was documented in only 2.2% of 221,192 visits from January 2, 2007, to January 6, 2013. The most common off-loading option was the postoperative shoe (36.8%) and TCC (16.0%). There were significantly more amputations within 1 year for non-TCC-treated DFUs compared with TCC-treated DFUs (5.2% vs 2.2%; P = .001). The proportion of healed wounds was slightly higher for TCC-treated DFUs versus non-TCC-treated DFUs (39.4% vs 37.2%). Infection rates were significantly higher for non-TCC-treated DFUs compared with TCC-treated DFUs (2.6 vs 1.6; P = 2.1 × 10). Only 59 clinics used TCC (61%); 57% of those clinics used traditional TCC, followed by TCC-EZ (36%). Among clinics using any type of TCC, 96.3% of the DFUs that did not receive TCC were "TCC-eligible" ulcers. Among clinics using "traditional" TCC systems, 1.4% of DFUs were treated with TCC, whereas clinics using TCC-EZ provided TCC to 6.2% of DFUs., Conclusion: Total contact casting is vastly underutilized in DFU wound care settings, suggesting that there is a gap in practice for adequate off-loading. New, easier-to-apply TCC kits, such as the TCC-EZ, may increase the frequency with which this ideal form of adequate off-loading is utilized.

Objective: Recurrence of plantar foot ulcers is a common and major problem in diabetes but not well understood. Foot biomechanics and patient behavior may be important. The aim was to identify risk factors for ulcer recurrence and to establish targets for ulcer prevention., Research Design and Methods: As part of a footwear trial, 171 neuropathic diabetic patients with a recently healed plantar foot ulcer and custom-made footwear were followed for 18 months or until ulceration. Demographic data, disease-related parameters, presence of minor lesions, barefoot and in-shoe plantar peak pressures, footwear adherence, and daily stride count were entered in a multivariate multilevel logistic regression model of plantar foot ulcer recurrence., Results: A total of 71 patients had a recurrent ulcer. Significant independent predictors were presence of minor lesions (odds ratio 9.06 [95% CI 2.98-27.57]), day-to-day variation in stride count (0.93 [0.89-0.99]), and cumulative duration of past foot ulcers (1.03 [1.00-1.06]). Significant independent predictors for those 41 recurrences suggested to be the result of unrecognized repetitive trauma were presence of minor lesions (10.95 [5.01-23.96]), in-shoe peak pressure <200 kPa with footwear adherence >80% (0.43 [0.20-0.94]), barefoot peak pressure (1.11 [1.00-1.22]), and day-to-day variation in stride count (0.91 [0.86-0.96])., Conclusions: The presence of a minor lesion was clearly the strongest predictor, while recommended use of adequately offloading footwear was a strong protector against ulcer recurrence from unrecognized repetitive trauma. These outcomes define clear targets for diabetic foot screening and ulcer prevention., (© 2014 by the American Diabetes Association.)

Objective: To assess the perceived usability and use of custom- made footwear in diabetic patients who are at high-risk for foot ulceration, and to elucidate the determinants of usability and use., Design: Survey., Subjects: A total of 153 patients with diabetes, peripheral neuropathy, prior plantar foot ulceration and newly prescribed custom-made footwear, recruited from 10 Dutch multidisciplinary foot clinics., Methods: The Questionnaire of Usability Evaluation was used to assess the patients' perception of weight, appearance, comfort, durability, donning/doffing, stability, benefit and overall appreciation of their prescription footwear (all expressed as visual analogue scores). Data on priorities for usability and footwear use (in h/day) were obtained from patient reports. Multivariate logistic regression analysis was used to assess determinants of usability and use., Results: Median (interquartile range) score for overall appreciation was 8.3 (7.1-9.1). Scores ranged from 6.5 (4.5-8.6) for weight to 9.6 (6.3-9.9) for donning/doffing. Footwear comfort was listed most often (33.3%) as the highest priority. Footwear use was <60% of daytime (where daytime was defined as 16 h out of bed) in 58% of patients. The only significant determinant of footwear use was the perceived benefit of the footwear (p = 0.045)., Conclusion: Perceived usability of footwear was mostly positive, although individual scores and priorities varied considerably. Footwear use was low to moderate and dependent only on the perceived benefit of the footwear. Therefore, practitioners should focus on enhancing the patient's ap-preciation of the therapeutic benefit of custom-made footwear.

The transtibial amputation is a common operation for which there is little agreement regarding which technique provides the most reliable and resilient outcomes. We performed a retrospective chart review of all transtibial amputations performed by a single surgeon between 2004 and 2011 using the posterior myocutaneous flap with triceps surae myodesis technique. A stepwise logistic regression analysis was performed to evaluate the association between independent variables and dependent outcome variables. A total of 270 patients with 294 transtibial amputations were identified. Ambulation data were available for 192 patients with a mean follow-up 18.4 months. This cohort had an overall ambulation rate of 75%, a 12% incidence of stump wounds, 24% operative revision rate and only 2% required conversion to a transfemoral amputation. The posterior myocutaneous flap provides durable and reliable soft tissue coverage in the setting of a transtibial amputation.

Orthotic insoles are commonly used in the treatment of the diabetic foot to prevent ulcerations. Choosing suitable insole material is vital for effective foot orthotic treatment. We examined seven types of orthotic materials. In consideration of the key requirements and end uses of orthotic insoles for the diabetic foot, including accommodation, cushioning, and control, we developed test methods for examining important physical properties, such as force reduction and compression properties, insole-skin friction, and shear properties, as well as thermal comfort properties of fabrication materials. A novel performance index that combines various material test results together was also proposed to quantify the overall performance of the insole materials. The investigation confirms that the insole-sock interface has a lower coefficient of friction and shearing stress than those of the insole-skin interface. It is also revealed that material brand and the corresponding density and cell volume, as well as thickness, are closely associated with the performance of moisture absorption and thermal comfort. On the basis of the proposed performance index, practitioners can better understand the properties and performance of various insole materials, thus prescribing suitable orthotic insoles for patients with diabetic foot.

In people with diabetes mellitus, foot ulcers are a major problem because they increase the risk of a foot infection and amputation and reduce quality of life. After a foot ulcer has healed, the risk of recurrence is high. Orthopaedic shoes and orthotics are often prescribed to high risk patients and aim to reduce the mechanical pressure on the plantar surface of the foot. Orthopaedic footwear that is modified to reduce pressure is not much more effective in preventing foot ulcer recurrence than orthopaedic footwear that did not undergo such modification, unless the shoes are worn as recommended. In that case, the risk of ulcer recurrence is reduced by 46%. In patients with a history of ulceration, compliance in wearing orthopaedic shoes at home is low, while these patients walk more inside the house than outside the house. Foot pressure measurements should be part of the prescription and evaluation of orthopaedic footwear for patients at high risk for foot ulceration.

Aim: To conduct a systematic review which examined the effectiveness of footwear and other removable off-loading devices as interventions for the treatment of diabetic foot ulcers or the alteration of biomechanical factors associated with ulcer healing and to discuss the quality and interpret the findings of research to date., Methods: The CINAHL, Medline and Cochrane Register of Controlled Trials databases were searched with seventeen articles identified for review., Results: Majority of the identified studies were randomised control trials which compared the ulcer healing rates of different footwear and other removable off-loading device interventions. Three categories of interventions were identified; 1) removable cast walkers (RCWs), 2) half or heel relief shoes and 3) therapeutic shoes. Most studies compared at least one intervention to a total contact cast (TCC). Factors which influenced study findings such as TCC application method, compliance, activity levels, and the footwear worn on the contralateral limb are discussed with recommendations provided for future studies., Conclusion: Due to the lack of randomised controlled studies conducted in this area it is not currently possible to make strong conclusions on the interventions effectiveness. However, it appears the currently available therapeutic shoes were the least effective intervention followed by half or heel relief shoes. RCWs were found to be the most effective of the removable devices.

Objective: Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence., Research Design and Methods: We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken., Results: On the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk -11%, odds ratio 0.80 [95% CI 0.44-1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk -46%, odds ratio 0.38 [0.15-0.99], P = 0.045)., Conclusions: Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.

Diabetic foot ulcers (DFUs) are a chronic, non-healing complication of diabetes that lead to high hospital costs and, in extreme cases, to amputation. Diabetic neuropathy, peripheral vascular disease, abnormal cellular and cytokine/chemokine activity are among the main factors that hinder diabetic wound repair. DFUs represent a current and important challenge in the development of novel and efficient wound dressings. In general, an ideal wound dressing should provide a moist wound environment, offer protection from secondary infections, remove wound exudate and promote tissue regeneration. However, no existing dressing fulfills all the requirements associated with DFU treatment and the choice of the correct dressing depends on the wound type and stage, injury extension, patient condition and the tissues involved. Currently, there are different types of commercially available wound dressings that can be used for DFU treatment which differ on their application modes, materials, shape and on the methods employed for production. Dressing materials can include natural, modified and synthetic polymers, as well as their mixtures or combinations, processed in the form of films, foams, hydrocolloids and hydrogels. Moreover, wound dressings may be employed as medicated systems, through the delivery of healing enhancers and therapeutic substances (drugs, growth factors, peptides, stem cells and/or other bioactive substances). This work reviews the state of the art and the most recent advances in the development of wound dressings for DFU treatment. Special emphasis is given to systems employing new polymeric biomaterials, and to the latest and innovative therapeutic strategies and delivery approaches., (Copyright © 2013 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.)

To systematically assess published reports on the efficacy of electrophysical therapy in the treatment of diabetic foot ulcers, including electrical stimulation, low-level laser therapy, therapeutic ultrasound and electromagnetic therapy. Databases searched included MEDLINE, CINAHL, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) from 1966 to 2011. Studies reviewed included only randomised controlled trials (RCTs) on treatment with electrophysical modalities compared with sham, conventional treatment or other electrophysical modalities. Information extracted were objective measures of healing and data useful for the calculation of effect size. Eight RCTs were eventually included in the critical appraisal, with a combined total of 325 participants. Five studies were conducted on electrical stimulation, two on phototherapy and one on ultrasound. All studies reported that the experimental group was significantly more favourable than the control or sham group. The pooled estimate of the number of healed ulcers of the three studies on electrical stimulation compared to the control or sham electrical stimulation showed statistical significance [mean difference of 2·8 (95% CI = 1·5-5·5, P = 0·002] in favour of electrical stimulation. The results indicated potential benefit of using electrophysical therapy for managing diabetic foot ulcers. However, due to the small number of trials ever conducted, the possibility of any harmful effects cannot be ruled out, and high-quality trials with larger sample sizes are warranted., (© 2012 The Authors. International Wound Journal © 2012 Blackwell Publishing Ltd and Medicalhelplines.com Inc.)

Effective off-loading is considered to be an important part of the successful clinical management of diabetic foot ulcers. The aim of this systematic review is to investigate the safety and effectiveness of different off-loading devices for the treatment of diabetic foot ulcers. The medical literature was extensively searched from January 1966 to May 2012. Systematic reviews and controlled studies that compared the use of different off-loading devices formed the evidence base. Studies were critically appraised to determine their risk of methodological bias, and data were extracted. Results were pooled using random effects meta-analysis and tested for heterogeneity. When compared with removable devices, non-removable off-loading devices were found, on average, to be more effective at promoting the healing of diabetic foot ulcers (RRp  = 1.43; 95% CI 1.11, 1.84; I(2)  = 66.9%; p = 0.001; k = 10). Analysis, stratified by type of removable device, did not detect a statistically significant difference between non-removable off-loading devices and removable cast walkers; however, on average non-removable off-loading devices performed better than therapeutic shoes at promoting the healing of diabetic foot ulcers (RRp  = 1.68; 95% CI 1.09, 2.58; I(2)  = 71.5%; p = 0.004; k = 6). The two types of non-removable off-loading devices i.e. total contact casts and instant total contact casts (removable cast walker rendered irremovable by securing with bandage or lace), were found to be equally effective (RRp  = 1.06; 95% CI 0.88, 1.27; I(2)  = 3.3%; p = 0.31; k = 2). In conclusion, non-removable off-loading devices regardless of type, are more likely to result in ulcer healing than removable off-loading devices, presumably because patient compliance with off-loading is facilitated., (Copyright © 2013 John Wiley & Sons, Ltd.)

Aims: Custom-made therapeutic footwear is often prescribed to patients with diabetic neuropathy, foot deformity and a healed plantar foot ulcer. Offloading these feet is important to prevent ulcer recurrence. The aim was to evaluate the offloading effect of custom-made footwear in these patients., Methods: In 171 patients with diabetic neuropathy (336 feet) with foot deformity and a recently healed plantar foot ulcer, plantar pressures walking barefoot and inside new custom-made footwear were measured. At the previous ulcer location and at locations of highest barefoot pressure attributable to the deformity, in-shoe pressures were compared with non-deformed feet. The footwear was considered effective in offloading when in-shoe peak pressure at these locations was < 200 kPa., Results: Mean in-shoe peak pressures ranged between 211 and 308 kPa in feet with forefoot deformity (vs. 191-222 kPa in non-deformed feet) and between 140 and 187 kPa in feet with midfoot deformity (vs. 112 kPa in non-deformed feet). Offloading was effective in 61% of all feet with deformity, 81% of feet with midfoot deformity, 44% of feet with forefoot deformity and 62% of previous ulcer locations. Inter-subject variability in measured in-shoe plantar pressure was large., Conclusions: Offloading in custom-made footwear is often not sufficiently achieved in high-risk diabetic feet with deformity. Highest offloading success rates were seen at known high-risk locations such as previous ulcer locations and Charcot feet, the lowest success rates in forefoot deformities. Together with the large inter-subject variability in pressure outcomes, this emphasizes the need for evidence-based prescription and evaluation procedures to assure adequate offloading., (© 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.)

Aims: To assess the value of using in-shoe plantar pressure analysis to improve and preserve the offloading properties of custom-made footwear in patients with diabetes., Methods: Dynamic in-shoe plantar pressures were measured in new custom-made footwear of 117 patients with diabetes, neuropathy, and a healed plantar foot ulcer. In 85 of these patients, high peak pressure locations (peak pressure > 200 kPa) were targeted for pressure reduction (goal: > 25% relief or below an absolute level of 200 kPa) by modifying the footwear. After each of a maximum three rounds of modifications, pressures were measured. In a subgroup of 32 patients, pressures were measured and, if needed, footwear was modified at 3-monthly visits for 1 year. Pressures were compared with those measured in 32 control patients who had no footwear modifications based on pressure analysis., Results: At the previous ulcer location and the highest and second highest pressure locations, peak pressures were significantly reduced by 23%, 21% and 15%, respectively, after modification of footwear. These lowered pressures were maintained or further reduced over time and were significantly lower, by 24-28%, compared with pressures in the control group., Conclusion: The offloading capacity of custom-made footwear for high-risk patients can be effectively improved and preserved using in-shoe plantar pressure analysis as guidance tool for footwear modification. This provides a useful approach to obtain better offloading footwear that may reduce the risk for pressure-related diabetic foot ulcers., (© 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.)

Objective: To assess the validity and feasibility of a new temperature-based adherence monitor to measure footwear use., Design: Observational study., Setting: University medical center and participants' homes., Participants: Convenience sample of healthy subjects (n=11) and neuropathic diabetic patients at high risk for foot ulceration (n=14)., Interventions: In healthy subjects, the validity of the in-shoe attached adherence monitor was investigated by comparing its registrations of donning and doffing of footwear during 7 days to an accurately kept log registration. In diabetic patients, the feasibility of using the adherence monitor for 7 days in conjunction with a time-synchronized ankle-worn step activity monitor to register prescribed footwear use during walking was assessed. Furthermore, a usability questionnaire was completed., Main Outcome Measures: For validity, the mean time difference and 95% confidence interval (CI) between moments of donning/doffing footwear recorded with the adherence monitor and in the log were calculated. For feasibility, technical performance, usability, and the percentage of steps that the footwear was worn (adherence) were assessed., Results: The mean time difference between the adherence monitor and log recordings was 0.4 minutes (95% CI, 0.2-0.6min). One erroneous recording and 2 incomplete recordings were obtained in diabetic patients. Three patients reported discomfort with the step activity monitor, and 4 patients would not favor repeated testing. Patients used their footwear for between 9% and 99% of their walking steps., Conclusions: The adherence monitor shows good validity in measuring when footwear is used or not, and is, together with instrumented monitoring of walking activity, a feasible and objective method to assess treatment adherence. This method can have wide application in clinical practice and research regarding prescribed footwear and other body-worn assistive devices., (Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: Recent literature on acute diabetic Charcot osteoarthropathy (CA) reports unusually long periods of off-loading. Data suggest that this might increase the re-currence rate. Subsequently we evaluated the influence of duration of off-loading on the risk of required re-casting., Research Design and Methods: In this retrospective consecutive series from 2000 to 2005, 56 people with diabetes and an acute Charcot foot were included. The inclusion criteria were an initial persistent temperature difference more than 2°C between the two feet, oedema, and typical hot spots on a bone scintigram, radiology, and a typical clinical course. Treatment was off-loading in a removable cast and 2 crutches. In-door walking was allowed. Gradually augmented weight bearing was prescribed when the skin temperature difference had decreased to a level less than 2°C and edema had subsided. Re-casting was required for immediate exacerbation during re-load as well as for recurrence - defined as new swelling and skin temperature difference of more than 2°C in the same foot occurring after a stable interval of at least one month after full weight bearing., Results: The duration of off-loading for all patients was 141±21 days (mean±SD). Three patients (5%) were re-casted immediately for exacerbation after re-load and 7 patients (12 %) after recurrence of the CA. Duration of re-casting was 79±44 days. The primary period of off-loading was not statistically significantly different for those not requiring versus those requiring re-casting: 142±24 days compared to 134±41 days. Neither were the differences in demographic data, metabolic regulation, BMI or localization of CA., Conclusions: Patients with risk of exacerbation or recurrence of CA could not be identified in the present study and there was no relation to the duration of off-loading. Nevertheless off-loading periods with immobilisation should be kept as short as possible, due to other side effects. This can be obtained by early gradual augmented re-loading., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Reducing weight-bearing stress to diabetic foot ulcers is critical to healing and commonly called offloading. Removable cast walkers are frequently used for offloading; however, patient compliance is often poor. Walkers commonly extend to the knee. Patients complain about walkers' weight and diminished balance with their use. This study compared the offloading capacity of walkers that varied by height. Heights included: knee, ankle, and shoe levels. To ensure a fair comparison the outsole and insole were standardized across the devices., Methods: Eleven diabetic subjects with moderate to high risk of ulceration were recruited. Subjects completed four 20 m walking trials. Subjects performed one trial with each walker and one trial with an athletic shoe. Primary outcomes focused on plantar loading and were measured by pressure insoles. Secondary outcomes were associated with gait kinematics as collected by body worn sensors., Findings: Significant differences were found for the peak pressure and pressure time integrals of the different footwear. All walkers performed better than the athletic shoe. The ankle and knee-high devices performed best. Center of mass rotation data showed a trend of the ankle walker yielding a smaller range of motion (18% medial/lateral and 22% anterior/posterior) than the knee level., Interpretation: The ankle-high walker was able to provide similar offloading capacities as the knee-high walker. The diminished weight, along with potentially improved stability, may result in improved compliance with ankle-high walkers. A study comparing the use of the two devices for treating ulcers is now suggested., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Background: Polyneuropathy is a complication of diabetes mellitus that has been very challenging for clinicians. It results in high public health costs and has a huge impact on patients' quality of life. Preventive interventions are still the most important approach to avoid plantar ulceration and amputation, which is the most devastating endpoint of the disease. Some therapeutic interventions improve gait quality, confidence, and quality of life; however, there is no evidence yet of an effective physical therapy treatment for recovering musculoskeletal function and foot rollover during gait that could potentially redistribute plantar pressure and reduce the risk of ulcer formation., Methods/design: A randomised, controlled trial, with blind assessment, was designed to study the effect of a physiotherapy intervention on foot rollover during gait, range of motion, muscle strength and function of the foot and ankle, and balance confidence. The main outcome is plantar pressure during foot rollover, and the secondary outcomes are kinetic and kinematic parameters of gait, neuropathy signs and symptoms, foot and ankle range of motion and function, muscle strength, and balance confidence. The intervention is carried out for 12 weeks, twice a week, for 40-60 min each session. The follow-up period is 24 weeks from the baseline condition., Discussion: Herein, we present a more comprehensive and specific physiotherapy approach for foot and ankle function, by choosing simple tasks, focusing on recovering range of motion, strength, and functionality of the joints most impaired by diabetic polyneuropathy. In addition, this intervention aims to transfer these peripheral gains to the functional and more complex task of foot rollover during gait, in order to reduce risk of ulceration. If it shows any benefit, this protocol can be used in clinical practice and can be indicated as complementary treatment for this disease., Trial Registration: ClinicalTrials.gov Identifier: NCT01207284.

Type 2 diabetes affects almost 4% of the world's population and the rates of amputation range from 43.9 per 100,000 per year among Americans. As healthcare providers, we can motivate our patients and improve compliance if we better understand the learning styles of our patients. The need to better prepare patients and caregivers to manage illnesses and participate as partners in their care has been recognized as a national priority. This study of educational preferences for diabetic patients with a risk for developing foot ulcers utilizes a written education plan provided by the hospital and a video developed by the staff of the vascular surgery inpatient unit. One hundred participants were initially requested; however, the final sample of 30 individuals completed the study from the beginning of hospitalization to day of discharge. The majority of patients were able to increase their post-education test scores using the video education tool. A significant difference between the pretest and posttest scores for the groups who received video education was found. In contrast, although there was an improvement in pretest and posttest scores for the written-material-only group and the written/video material group, this difference was not statistically significant. Diabetes in adults is increasing in our community; however, the sample size was not representative of the population. A follow-up study is needed to provide more evidence of patient preferences when education about their illness is presented in any format., (Copyright © 2011 Society for Vascular Nursing, Inc. Published by Mosby, Inc. All rights reserved.)

The best predicator of amputation is a history of previous amputation. A history of lower extremity ulceration or amputation increases the risk for further ulceration, infection, and subsequent amputation. Early diagnosis, control of risk factors, medical management, and timely revascularization may aid in avoiding limb loss. Treatment combines patient education, orthoses, footwear, and off-loading. Patients at risk should understand the implications of loss of protective sensation, the importance of carefully monitoring their feet, proper care of the foot, and always wearing protective footwear. It is important to control risk factors, protect the limb, recognize early signs of inflammation, and optimize wound care. Lower extremity amputation is a common outcome for patients with an at-risk foot. Amputation may be the best option to optimize function., (Copyright © 2011 Society for Vascular Nursing, Inc. Published by Mosby, Inc. All rights reserved.)

Background: Means to improve patient satisfaction and their compliance are essential for the successful outcome of medical interventions, e.g. supply of orthopedic shoes or orthoses in orthopedic patients. A useful validated questionnaire to monitor the subjective opinion of the patients is still lacking., Methods: In a randomised single blinded study we created a new questionnaire with two parts. Part one deals with ten questions on patient data and illness. Part two consists of 13 questions about pain, disabilities in activities of daily life (ADL), use of painkillers, satisfaction, history of ulceration, correction of shoes and orthoses, handling and compliance using a scale of 1-6. Questions were chosen by asking a group of experts (four experienced physicians of two universities and four shoemaker master-craftsmen). Then an items reduction was performed. The reliability was tested in a pre- and retest in 20 patients of our orthopedic clinic. Then the questionnaire was validated by comparing 40 patients of our orthopedic clinic (intervention group) with 180 subjects without orthopedic treatment (control group) chosen at random. The questionnaire was always done anonymously and without the help of the interviewer. Exclusion criteria for the control group were any kind of orthopedic treatment of the lower limb in the last 2 years, orthopedic shoes or lumbar sciatic pain. Exclusion criteria for both groups were minor or major amputations, inability to walk outdoors without help., Results: We demonstrated highly significant differences for each single question and the total score between orthopedic patients and healthy probands. Additionally, we saw significantly poorer scores for patients suffering from diabetes in the control group, patients with polyneuropathy and those without polyneuropathy, as well as for women vs. men. There was a high rate of diabetics (11 %) in the control group in analogy to the current literature., Discussion: The new questionnaire discriminates highly significantly between healthy and ill probands. Interindividually a screening of people at risk is possible or a comparison of different interventions. Intraindividually it could be used to monitor patient satisfaction after interventions. Objectivation of patient satisfaction is important to improve their compliance and outcome., (© Georg Thieme Verlag KG Stuttgart · New York.)

Proper shoe size is an important element of foot health, especially in the elderly and diabetic populations. An improper fit can lead to pain, functional limitations, and falls. The aim of the present study was to determine the proportion of adults who are unaware of their own shoe size in 3 different New York City populations: a foot specialist private practice, an academic diabetic foot and ankle clinic, and a charity care center, the Bowery clinic, serving the homeless. A shoe size mismatch was defined as a difference of at least 0.5 in size between the measured foot and the shoe size. Demographic data were collected during the examination and retrospectively by chart review. A total of 235 volunteers participated in our study. A significant difference in the prevalence of the measured foot and shoe size mismatch was found between the cohort from the private practice compared with both the diabetic foot and ankle clinic and the Bowery clinic (P < .01 and P < .01, respectively). A significant difference was also detected (P < .05) between the private practice and the Bowery mission cohort when a difference of at least 1.5 sizes was present between the measured foot and the shoe size. Of those with a foot to shoe size mismatch, 60% had a difference of more than 0.5 in the shoe size between their right and left foot. In conclusion, our findings suggest that proper footwear sizing is lacking among a large proportion of our patients and that an adequate shoe size can be achieved with proper counseling., (Copyright © 2011 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.)

Purpose: To enhance the clinician's competence in using nutrition as an integral part of wound healing., Target Audience: This continuing education activity is intended for physicians and nurses with an interest in skin and wound care., Objectives: After participating in this educational activity, the participant should be better able to: 1. Analyze the effects of specific nutritional deficiencies and patient parameters on wound healing capabilities. 2. Accurately interpret laboratory values related to nutritional status. 3. Apply evidence-based nutrition guidelines for improved wound healing.

Amputations in patients with diabetes, while often preventable, are unfortunately a far too common outcome. The roles of the certified or licensed pedorthist, certified orthotist, and the certified prosthetist should not be undervalued in the prevention of diabetic foot complications (eg, amputations, revisions, and foot infections secondary to skin ulcerations) and in returning the patient a normal, active, and productive lifestyle in the event of an amputation. This article highlights the roles these specialists play in treating patients with partial foot amputation., (Published by Elsevier Inc.)

The Syme's ankle disarticulation is an end-bearing amputation level that provides stable walking, requires minimal physical therapy gait training, and rarely requires hospitalization on a rehabilitation unit. This article discusses patient selection, surgical technique, and rehabilitation of an underused rehabilitation amputation level., (2010 Elsevier Inc. All rights reserved.)

Aims: Gait characteristics and balance are altered in diabetic individuals. Little is known about possible treatment strategies. This study evaluated the effect of a specific training program on diabetic patients' gait., Methods: A randomized controlled trial (N=71) with an intervention (IG) (N=35), and control group (CG) (N=36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-oriented strengthening. Controls received no treatment., Results: After intervention the IG increased their habitual walking speed by 0.149ms(-1) (0.54kmh(-1)) on tarred terrain and by 0.169ms(-1) (0.61kmh(-1)) on the cobblestones. This significant treatment effect (p<0.001) decreased slightly at the six-month follow-up, but remained significant (p<0.001). In a similar manner, significant improvement was observed for cadence, gait cycle time and stance time on both terrains. All outcomes except stance time on the tarred terrain remained significant at the six-month follow-up. No significant effect was observed for stride length and the coefficient of variation of gait cycle time (on either surface) at the corrected significance level of p<0.004. CG patients' parameters all remained unchanged or progressively deteriorated compared to baseline values., Discussion: Cadence contributed 80%, whereas stride length only contributed 20% to the change of gait velocity. This may be due to the treatment or to diabetic patients' potential to regulate their cadence and stride length., Conclusion: A specific training program can improve diabetic patients' gait in a real life environment. A challenging environment highlights treatment effects on patients' gait better than an evenly tarred surface., (Copyright 2010 Elsevier B.V. All rights reserved.)

Purpose: The purpose of this study was to determine the influence of having a family member who experienced an amputation on one's own perceived risk and fear of experiencing a diabetes-related amputation., Methods: This was a descriptive cross-sectional study using paper-and-pencil surveys by mail. Adults with type 2 diabetes and a family history of diabetes attending a self-management education program in the Metropolitan New York/New Jersey area were recruited. Measures were completed about risk perception and fear of amputation, emotional representations of diabetes from the Illness Perception Questionnaire, and the foot self-care behavior component of the Summary of Diabetes Self-care Activities Survey. The authors estimated the variability in foot self-care that was accounted for by risk perception and fearful memories., Results: In those who remembered a family member needing an amputation, high perceived risk and fear was associated with less routine foot self-care. For those without family history of amputation, fear was positively associated with foot self-care., Conclusions: Motivation for foot self-care behavior may be driven by risk perception and emotional responses. The ways in which risk perception and fear influence motivation for preventive foot self-care behavior are influenced by whether one's family member was affected by an amputation. Probing about the influence of the patient's legacy of diabetes may be helpful when customizing education plans.

Aims/hypothesis: Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients., Methods: This was a randomised controlled trial (n=71) with an intervention (n=35) and control group (n=36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening (twice weekly over 12 weeks). Controls received no treatment. Individuals were allocated to the groups in a central office. Gait, balance, fear of falls, muscle strength and joint mobility were measured at baseline, after intervention and at 6-month follow-up., Results: The trial is closed to recruitment and follow-up. After training, the intervention group increased habitual walking speed by 0.149 m/s (p<0.001) compared with the control group. Patients in the intervention group also significantly improved their balance (time to walk over a beam, balance index recorded on Biodex balance system), their performance-oriented mobility, their degree of concern about falling, their hip and ankle plantar flexor strength, and their hip flexion mobility compared with the control group. After 6 months, all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength. Two patients developed pain in their Achilles tendon: the progression for two related exercises was slowed down., Conclusions/interpretation: Specific training can improve gait speed, balance, muscle strength and joint mobility in diabetic patients. Further studies are needed to explore the influence of these improvements on the number of reported falls, patients' physical activity levels and quality of life., Trial Registration: ClinicalTrials.gov NCT00637546, Funding: This work was supported by the Swiss National Foundation (SNF): PBSKP-123446/1/

For patients with diabetes mellitus and diabetic foot syndrome customized orthopedic shoes represent the most effective treatment to avoid foot ulceration and amputation. A total of 53 patients suffering from diabetes and treated with customized orthopedic shoes for more than 5 years were included in the study. Of the patients 91% had peripheral artery occlusion disease, polyneuropathy and diabetic neuropathic osteoarthropathy (DNOAP) and in nearly 25% amputation of one limb had already been carried out. The incidence of ulcers over a time period of 5 years was assessed from the patient records and questioning the patients. Questions on the duration of wearing orthopedic shoes, the durability of the shoes and resulting pain were also included. All patients except for one had problems walking on uneven surfaces. Of the patients 89% claimed to have used their shoes always or nearly always and 25% of the shoes had to be replaced after 1 year. The incidence of ulcers was 38% after 5 years. Treatment with customized orthopedic shoes is an effective method to prevent ulcers and amputation. To be successful it is necessary to control that the shoes are made correctly. Not all shoes last as long as 2 years.

Rehabilitation of patients suffering from diabetic foot syndrome requires a holistic team approach. Besides the treatment of the local problems the treatment of the basic disease with education, correct nutrition and best possible drug treatment is of importance to prevent subsequent complications. A diabetic foot schooling is of importance to prevent secondary ulcers. Correct wound care with broad knowledge of wound healing stages, a variety of wound dressings and skilled knowledge in prosthetic and orthopedic shoe fitting plays a predominant role. The treatment is completed by physiotherapeutic gait training including the correction of gait deviations, psychological support and proper care.

Aims: The recurrence of foot ulcers is a significant problem in people with diabetic neuropathy. The purpose of this study was to measure in-shoe plantar pressures and other characteristics in a group of neuropathic patients with diabetes who had prior foot ulcers which had remained healed., Methods: This was an epidemiological cohort study of patients from diabetes clinics of two Swedish hospitals. From a database of 2625 eligible patients, 190 surviving patients with prior plantar ulcers of the forefoot (hallux or metatarsal heads) caused by repetitive stress were identified and 49 patients agreed to participate. Barefoot and in-shoe plantar pressures were measured during walking. Data on foot deformity, activity profiles and self-reported behaviour were also collected., Results: Mean barefoot plantar peak pressure at the prior ulcer site (556 kPa) was lower than in other published series, although the range was large (107-1192 kPa). Mean in-shoe peak pressure at this location averaged 207 kPa when measured with an insole sensor. Barefoot peak pressure only predicted approximately 35% of the variance of in-shoe peak pressure, indicating variation in the efficacy of the individual footwear prescriptions (primarily extra-depth shoes with custom insoles)., Conclusions: We propose that the mean value for in-shoe pressures reported in these patients be used as a target in footwear prescription for patients with prior ulcers. Although plantar pressure is only one factor in a multifaceted strategy to prevent ulcer recurrence, the quantitative focus on pressure reduction in footwear is likely to have beneficial effects.

Background: Diabetes mellitus is one of the most common diseases worldwide and the number of patients is expected to increase dramatically in future. Plantar ulceration is partly caused by high plantar pressures and a major complication in diabetic patients., Purpose: The aim of this study was to investigate the pressure-relieving effects of two vacuum orthoses in patients with diabetes mellitus., Methods: Twenty patients with diabetes mellitus were included. They presented with plantar callosities but no ulceration. Exclusion criteria included the use of walking aids and other systemic diseases. Plantar pressure distribution was measured with sensor insoles (Pedar-X, Novel GmbH) during walking in two vacuum orthoses, a post-operative shoe and an off-the-shelf shoe as reference condition. Statistical analysis was conducted using Friedman and Wilcoxon signed-rank tests., Results: Significant differences in plantar pressure distribution were found between the four walking conditions. The contact area increased in the midfoot with the vacuum orthoses. Maximum force and peak pressures showed a significant decrease under the rearfoot and forefoot and increased in the midfoot area during walking with both vacuum orthoses. The high-cut vacuum orthosis revealed equal pressure relief under the forefoot and significantly lower rearfoot pressures compared to the post-operative shoe., Conclusions: The vacuum orthoses demonstrated a comparable pressure-relieving efficacy under the forefoot to post-operative shoes. Using vacuum orthosis significantly benefited re-distribution of plantar pressure and the roll-over process. Clinical significance of the pressure-relieving efficacy could not be confirmed in this investigation and has to be addressed in further studies.

Shoes with rocker bottom soles are utilized by persons with diabetic peripheral neuropathy to reduce plantar pressures during gait. This population also has a high risk for falls. This study analyzed the effects of shoes with rocker bottom soles on the postural response during perturbed stance. Participants were 20 healthy subjects (16 women, 4 men) ages 22-25 years. Canvas shoes were modified by the addition of crepe sole material to represent two forms of rocker bottom shoes and a control shoe. Subjects stood on a dynamic force plate programmed to move backward at a velocity that produced an automatic postural response without stepping. Force plate data were collected for five trials per shoe type. Sway variables for center of pressure (COP) and center of mass (COM) included: mean sway amplitude, sway variance, time to peak, anterior and posterior peak velocities, functional stability margin, and peak duration time. Compared to control, both the experimental shoes had significantly larger COP and COM values for mean sway amplitude, sway variance and peak duration. The functional stability margins were significantly smaller for the experimental shoes while their anterior and posterior peak velocities were slower and time to peaks were significantly longer. In young healthy adults, shoes with rocker bottom soles had a destabilizing effect to perturbed stance, thereby increasing the potential for imbalance. These results raise concerns that footwear with rocker bottom sole modifications to accommodate an insensate foot may increase the risk of falls.

Purpose: Forefoot offloading shoes (FOS) are commonly used in clinical practice for treatment of plantar forefoot ulcers in the diabetic foot. The aim of this study was to assess the offloading efficacy of four different FOS models in comparison with a cast shoe and control shoe., Methods: In-shoe plantar pressures were measured during walking in each of the six footwear conditions in 24 neuropathic diabetic patients at high risk for plantar foot ulceration. For each of six foot regions, peak pressure, pressure-time integral, and force-time integral were calculated. Load transfer diagrams were developed to assess the footwear mechanisms of action. Perceived walking comfort was measured using a visual analogue scale (VAS). All comparisons between conditions were tested at P<0.05., Results: Peak pressures and pressure-time integrals at the metatarsal heads and hallux regions were significantly reduced (by 38-58%) in all FOS models when compared with the control shoe. The FOS also relieved metatarsal head peak pressure to a significantly larger extent than the cast shoe (approximately 20%). The load transfer diagrams showed a major transfer of approximately 40% of forefoot load to the midfoot explaining the offloading efficacy of the FOS. Perceived walking comfort was significantly lower in the FOS (VAS score 2.7-5.9) when compared with the control shoe (VAS 8.2) and cast shoe (VAS 6.8)., 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 be considered as this may potentially affect adherence to treatment.