Dissertations / Theses on the topic 'Diabetic foot'

Complications of type 2 diabetes mellitus are one of the major causes of morbidity and mortality around the world. Diabetic foot infections remain one of the major complications leading to a leg loss every 3 seconds due to amputations causing mental trauma and distress. In diabetic foot ulcers aerobes, anaerobes and fungus often interact with each other and form biofilms which is difficult to treat, enhancing antimicrobial resistance and lead to a non-healing ulcer. Co-existing peripheral vascular disease and neuropathy exacerbate the problems. In T2DM patients’ minor cuts and wounds, often lead to hard to treat and chronic ulcers which can worsen to gangrene formation which may lead to osteomyelitis compromising the mechanics of the foot. It is necessary to identify the virulence factors of these clinically significant microbes and to identify the resistance patterns regularly to limit the antibiotic usage and target to the specific organisms. A Cohort studies were carried out in India and in the UK to identify the risk factors among the diabetic foot patients along with their microbial aetiology and antibiotic resistance patterns from the tissue and pus samples. This part of the research has shown the presence of mixed cultures mainly from the Indian diabetic foot ulcer specimens with higher percentages of anaerobes than aerobes. Multi-drug resistant organisms were one of the peculiar characteristics of the diabetic foot ulcer profiles of Indian patients. As compared to the Indian patients, UK patients had few resistant organisms and the patients admitted to hospitals in India were at the last stage of foot ulcers whereas in the UK, surveillance and preventative strategies allow early detection and intervention. Currently there is a lack of rapid, robust and an inexpensive diagnostic method for the rapid typing and identification of clinically significant anaerobes. Another part of the research focussed on utilising the glycan-lectin interactions by developing a simple enzyme linked lectin sorbent assay by employing biotinylated lectins to develop to an enzyme linked lectin sorbent assay (ELLA) on whole cells, Proteinase K treated cells and glycolipids of clinically significant aerobes and anaerobes. This study is concluded by utilising the glycan-lectin interactions and to develop a rapid typing method for clinically significant Methicillin resistant and sensitive Staphylococcus aureus and epidermidis species. The rapid identification of anaerobes and typing of Peptostreptococcus species was also by facilitated by the developed ELLA method. Finegoldia magna is one of the most significant anaerobes from soft tissue infections and the Gas Chromatography – mass spectrometry (GC-MS) of the glycolipids of Finegoldia magna on composition analysis using show the presence of sialic acid which could be involved in pathogenesis. This sugar may be one of virulence factor employed by this organism in either attachment to the host or to other organisms.

Scientific supervisor: V.P. Shevchenko
Treatment of purulent-necrotic wounds against diabetes is particularly complicated, due to violation of intra-cellular metabolism, low regenerative potential and tendency to spread. Unsatisfactory results leads to the search for new factors of modern treatment. Experimental and clinical studies proved the effectiveness of high-power CO2 laser with purulent necrotic wounds in diabetics, due to strong bactericidal and coagulating action, minimal trauma surrounding tissue, and local immune-modulating effect. Aim:To improve results of surgical treatment of purulent necrotic wounds in diabetic foot syndrome (DFS) by using high-CO2 laser. When you are citing the document, use the following link http://essuir.sumdu.edu.ua/handle/123456789/27510

Background: Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period. Methods/design: This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru. Interventions: participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat (TM)). TempStat (TM) is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care. Outcomes: the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study. Discussion: This study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability.

The object of the thesis is to analyze the potential of thermography in the early diagnosis of type 2 diabetic foot. The main advantages of thermography are that it is simple to use, non-invasive, contactless, non-irradiant, and fast. A robust acquisition protocol is proposed, as well as a dedicated image processing algorithm. The algorithm includes a pre-processing step, plus a segmentation and a rigid registration procedures. Various parameters are assessed: the mean and standard deviation of right and left feet plantar surfaces temperaure, as well as the percentage of pixels such that the absolute point to point temperature difference between right and left feet is greater than 2.2°C. A percentage greater than 1% indicates significative hyperthermia regions. A transversal clinical study is conducted on a population of 85 persons of type 2 diabetic foot. They are classified in one of these three groups: Low risk, Medium risk, and High risk. For the Low risk group, the mean temperature is close to 32°C. For the medium one, it goes down to 31°C, and increases for the High risk group to a value of 32°C. In the early stage of diabetic foot, i.e. from the Low risk group to Medium risk group, the plantar foot surface temperature is lowered by 1°C: if this result is confirmed by other clinical tests, this information can be useful for the early diagnosis of diabetic foot. Finally, 9 images out of the 85 show hyperthermia, mainly in the heel or toes regions. This hyperthermia indication may be of a substantial assistance in the early prevention of foot ulcer and can help in avoiding subsequent foot amputation.

For individuals with type 2 diabetes, diabetic foot ulcers represent a significant health issue and the wound care cost is quite high. Currently, clinicians and nurses mainly base their wound assessment on visual examination of wound size and the status of the wound tissue. This method is potentially inaccurate for wound assessment and requires extra clinical workload. In view of the prevalence of smartphones with high resolution digital camera, assessing wound healing by analyzing of real-time images using the significant computational power of today’s mobile devices is an attractive approach for managing foot ulcers. Alternatively, the smartphone may be used just for image capture and wireless transfer to a PC or laptop for image processing. To achieve accurate foot ulcer image assessment, we have developed and tested a novel automatic wound image analysis system which accomplishes the following conditions: 1) design of an easy-to-use image capture system which makes the image capture process comfortable for the patient and provides well-controlled image capture conditions; 2) synthesis of efficient and accurate algorithms for real-time wound boundary determination to measure the wound area size; 3) development of a quantitative method to assess the wound healing status based on a foot ulcer image sequence for a given patient and 4) design of a wound image assessment and management system that can be used both in the patient’s home and clinical environment in a tele-medicine fashion. In our work, the wound image is captured by the camera on the smartphone while the patient’s foot is held in place by an image capture box, which is specially design to aid patients in photographing ulcers occurring on the sole of their feet. The experimental results prove that our image capture system guarantees consistent illumination and a fixed distance between the foot and camera. These properties greatly reduce the complexity of the subsequent wound recognition and assessment. The most significant contribution of our work is the development of five different wound boundary determination approaches based on different computer vision algorithms. The first approach employs the level set algorithm to determine the wound boundary directly based on a manually set initial curve. The second and third approaches are the mean-shift segmentation based methods augmented by foot outline detection and analysis. These two approaches have been shown to be efficient to implement (especially on smartphones), prior-knowledge independent and able to provide reasonably accurate wound segmentation results given a set of well-tuned parameters. However, this method suffers from the lack of self-adaptivity due to the fact that it is not based on machine learning. Consequently, a two-stage Support Vector Machine (SVM) binary classifier based wound recognition approach is developed and implemented. This approach consists of three major steps 1) unsupervised super-pixel segmentation, 2) feature descriptor extraction for each super-pixel and 3) supervised classifier based wound boundary determination. The experimental results show that this approach provides promising performance (sensitivity: 73.3%, specificity: 95.6%) when dealing with foot ulcer images captured with our image capture box. In the third approach, we further relax the image capture constraints and generalize the application of our wound recognition system by applying the conditional random field (CRF) based model to solve the wound boundary determination. The key modules in this approach are the TextonBoost based potential learning at different scales and efficient CRF model inference to find the optimal labeling. Finally, the standard K-means clustering algorithm is applied to the determined wound area for color based wound tissue classification. To train the models used in the last two approaches, as well as to evaluate all three methods, we have collected about 100 wound images at the wound clinic in UMass Medical School by tracking 15 patients for a 2-year period, following an IRB approved protocol. The wound recognition results were compared with the ground truth generated by combining clinical labeling from three experienced clinicians. Specificity and sensitivity based measures indicate that the CRF based approach is the most reliable method despite its implementation complexity and computational demands. In addition, sample images of Moulage wound simulations are also used to increase the evaluation flexibility. The advantages and disadvantages of three approaches are described. Another important contribution of this work has been development of a healing score based mechanism for quantitative wound healing status assessment. The wound size and color composition measurements were converted to a score number ranging from 0-10, which indicates the healing trend based on comparisons of subsequent images to an initial foot ulcer image. By comparing the result of the healing score algorithm to the healing scores determined by experienced clinicians, we assess the clinical validity of our healing score algorithm. The level of agreement of our healing score with the three assessing clinicians was quantified by using the Kripendorff’s Alpha Coefficient (KAC). Finally, a collaborative wound image management system between the PC and smartphone was designed and successfully applied in the wound clinic for patients’ wound tracking purpose. This system is proven to be applicable in clinical environment and capable of providing interactive foot ulcer care in a telemedicine fashion.

Diabetic peripheral neuropathy affecting the lower limbs is a common debilitating complication of diabetes mellitus. A significant proportion of affected patients are plagued by severe intractable painful symptoms. In addition to this, the insensitive foot is prone to deformity, trauma and resultant foot ulceration. This thesis deals with the management of diabetic foot problems, with particular reference to painful diabetic neuropathy and foot ulceration. The treatment of painful diabetic neuropathy is far from satisfactory and present therapeutic agents are not without undesirable side effects. The first study (Chapter 3) examines the relationship between blood glucose excursions and pain in patients with symptomatic diabetic neuropathy. Twenty type 1 diabetic patients with peripheral neuropathy (10 painful and 10 painless) wore a continuous glucose monitoring system (CGMS) for 3 days. Symptomatic patients kept a daily pain score diary. Measures of glycaemic stability, the mean amplitude of glycaemic excursions (MAGE) and the M-value were calculated. The study demonstrated that patients with painful neuropathy have greater glucose flux and possibly poorer diabetes control, compared to patients with painless neuropathy. The use of electrical stimulation therapy such as transcutaneous electrical nerve stimulation (TENS) and percutaneous electrical nerve stimulation (PENS), have been shown to provide some benefit when used to treat painful diabetic neuropathy. In a previous open-labelled study, pulsed-dose electrical current delivered through stocking electrodes was shown to produce an 80% reduction in painful symptoms. In the second study (Chapter 4) a double blind, controlled crossover study was carried out to assess the efficacy of pulsed-dose electrical current delivered through stocking electrodes. Thirty patients with painful diabetic neuropathy were randomised to wear silver plated stocking electrodes for 8 hours a night for 6 weeks (pulsed electric current of 50 micro amps delivered by a microcomputer). The control, identical stockings received an insignificant current (5 micro amps). Pre-treatment, weekly and end-of-treatment pain and sleep-disturbance scores were recorded. This study demonstrated that although symptomatic relief occurred, this form of treatment was no more effective than control in the treatment of painful diabetic neuropathy, suggesting that placebo may play a significant role in electro-analgesia. For adequate management of foot ulcers a systematic approach is required. A foot ulcer classification system should aid in planning treatment strategies, monitoring treatment effectiveness, predicting clinical outcomes, and improving communication among healthcare providers. The third study (Chapter 5) examines wound classification systems and factors, which affect the outcome of diabetic foot ulcers. Diabetic patients with new foot ulcers presenting during a 12-month period, had demographics and ulcer characteristics recorded at presentation. Ulcers were followed up until an outcome was noted. This study demonstrated that ulcer area, a measure of ulcer size, predicts the outcome of foot ulcers and that its inclusion into a diabetic foot classification system will make that system a better predictor of outcome. In the fourth study (Chapter 6), two commonly used foot ulcer classification systems are compared as predictors of clinical outcome. Both the Wagner system (grade) and the University of Texas system (grade and stage) were applied to new foot ulcers at presentation, and ulcers were followed up until an outcome was noted. The study revealed that increasing stage, regardless of grade, is associated with increased risk of amputation and prolonged ulcer healing time. The University of Texas system, which combines grade and stage, is a better predictor of outcome. Therefore, strict glucose control should be the first step in the struggle for pain control in patients with painful diabetic neuropathy before other forms of therapy are employed. Additionally, the use of a robust, fully descriptive foot ulcer classification system, such as the University of Texas system should be employed in the management of diabetic foot ulcers. A systematic approach to foot care will aid in reducing the high incidence of lower limb amputations.

In this thesis a new approach to sensing soft tissue damage in the diabetic foot is presented and multiple sensor modalities including linear and rotational accelerometers, temperature, humidity and galvanic skin response (GSR), pressure/-force, blood oxygen heart rate and fore foot flexure will be investigated with the aim of using multi modal sensing to improve understanding the diabetic foot. Bioimpedance is proposed and investigated as a novel measurement modality that directly observes the response of the tissue under test as a means of estimating tissue condition. The new sensing system and data collection with critical assessment is presented complimenting the existing metric of assessment. Diabetes is currently one of the greatest health risks facing the developed world where typically 6% of the population is diabetic and an estimated 1 in 3 people are currently in a pre-diabetic state. The condition adversely affects the body’s glycaemic control mechanisms leading to macro vascular stiffening alongside the possible onset of peripheral neuropathy thus increasing the risk of secondary pathologies such as retinopathy, kidney failure and diabetic foot disorder. For those living with diabetes the loss of a foot due to diabetic foot disorder is one of the most debilitating and feared side effects of diabetes. The national health service (NHS) in the United Kingdom (UK) currently amputates circa 100 lower legs a week due to diabetic complications of which about 85% are avoidable. As amputation leads to increased morbidity and mortality (68% at five years post 1st amputation) as well as a marked reduction in quality of life, this concern is well founded. Many metrics have been investigated as indicators of diabetic foot disorder, though none have shown sensitivity and specificity that would enable their use as a reliable diagnostic or predictor of ulceration. The following contributions to the body of knowledge will be presented: 1. Novel associations of sensors for monitoring the diabetic foot see Table 6.6. 2. The development of a novel bioimpedance measuring device. 3. The development of a novel wearable extensible multimodal sensing system. 4. Demonstrate direct current (DC) through textile GSR measurement. 5. Demonstrate the effect of caffeine on GSR coherence for the first time.

Diabetic foot ulcer (DFU), a major complication of both types 1 and 2 diabetes, develops in about 15–25% of people living with the disease. In Ghana, DFUs contribute to most hospital admissions (53%) among diabetics with high rates of amputation (33.3%) and death (8.8%). Diabetic foot ulcers are predisposed to infections from bacteria in the environment which normally colonise these wounds as multicellular communities called biofilms. Biofilms have been found to have increased resistance to antimicrobial agents probably due to the presence of an extracellular matrix that retards or prevents the entry of antimicrobial agents into the bacterial community, antibiotic resistance genes and/or the presence of persister cells that are unresponsive to antimicrobial agents. The work presented here studied the role of 2 multidrug resistant DFU isolates, Klebsiella pneumoniae and Proteus mirabilis in maintaining the chronicity of diabetic foot ulcers. Using 3 in vitro biofilm models; the conventional microtitre plate and Minimum Biofilm Eradication Concentration (MBEC™) High-Throughput assays and the Quasi–Vivo® continuous flow system, K. pneumoniae and P. mirabilis were found to be positive for acyl–homoserine lactone production, biofilm and persister cell producers and could resist and/or tolerate antibiotics such as ceftazidime and levofloxacin up to 1280 times their minimum inhibitory concentration. K. pneumoniae and P. mirabilis were also found to express the interspecies AI–2 quorum sensing molecules which significantly increased biofilm formation and fold induction of bioluminescence in a luxS mutant V. harveyi reference strain. Quorum sensing (QS) inhibition assays using baicalin hydrate, cinnamaldehyde and 2(5H)–furanone showed considerable inhibition of K. pneumoniae and P. mirabilis biofilm formation but failed to completely inhibit their growth. The combinatorial effects of antibiotics and QS inhibitors/antimicrobial peptides such as polymyxin B and polymyxin B nonapeptide determined as fractional inhibitory concentration (FIC) index suggests that, additive and synergistic effects produced by the combination of two antimicrobial agents have the potential to eradicate biofilms. Data from the FIC indices determined from the combination assays can provide the basis for the formulation of topical treatment for DFUs.

Identified differences of calcium metabolism indicate signs of calcium malabsorption in DM patients and the processes of bone resorption intensification. This allows to conclude that calcium metabolism status (in particular, the severity of bone resorption) has significance at the development of diabetic hard tissue foot lesions as well as diabetic neuropathies and angiopathies. Insulin has a significant anabolic effect. It is known that a insulin production decreasing leads to the bone mineralization decreasing, reducing of the calcium blood serum level, increasing of the calcium urine secretion. The bone tissue trophics is broken – this is a result of the carbohydrate metabolism changes at cells and vascular lesions during insulin deficiency. Calcium metabolism and bone resorption changes defined at the study point to the necessity of the calcium drugs including to the complex therapy of DM.

BACKGROUND: Diabetic foot complications are the leading cause of lower extremity amputation and diabetes-related hospitalisation in Australia. Studies demonstrate significant reductions in amputations and hospitalisation when health professionals implement best practice management. Whilst other nations have surveyed health professionals on specific diabetic foot management, to the best of the authors' knowledge this appears not to have occurred in Australia. The primary aim of this study was to examine Australian podiatrists' diabetic foot management compared with best practice recommendations by the Australian National Health Medical Research Council. METHODS: A 36-item Australian Diabetic Foot Management survey, employing seven-point Likert scales (0 = Never; 7 = Always) to measure multiple aspects of best practice diabetic foot management was developed. The survey was briefly tested for face and content validity. The survey was electronically distributed to Australian podiatrists via professional associations. Demographics including sex, years treating patients with diabetes, employment-sector and patient numbers were also collected. Chi-squared and Mann Whitney U tests were used to test differences between sub-groups. RESULTS: Three hundred and eleven podiatrists responded; 222 (71%) were female, 158 (51%) from the public sector and 11-15 years median experience. Participants reported treating a median of 21-30 diabetes patients each week, including 1-5 with foot ulcers. Overall, participants registered median scores of at least "very often" (>6) in their use of most items covering best practice diabetic foot management. Notable exceptions were: "never" (1 (1 - 3)) using total contact casting, "sometimes" (4 (2 - 5)) performing an ankle brachial index, "sometimes" (4 (1 - 6)) using University of Texas Wound Classification System, and "sometimes" (4 (3 - 6) referring to specialist multi-disciplinary foot teams. Public sector podiatrists reported higher use or access on all those items compared to private sector podiatrists (p < 0.01). CONCLUSIONS: This study provides the first baseline information on Australian podiatrists' adherence to best practice diabetic foot guidelines. It appears podiatrists manage large caseloads of people with diabetes and are generally implementing best practice guidelines recommendations with some notable exceptions. Further studies are required to identify barriers to implementing these recommendations to ensure all Australians with diabetes have access to best practice care to prevent amputations.

Successful management of diabetic foot pathologies is a challenge due to the influence of peripheral neuropathy, peripheral vascular disease, a susceptibility to infection and abnormal distribution of plantar pressures. The aim of the current research was to evaluate the effect of topical Phenytoin on healing in diabetic foot ulcers.

This thesis describes a number of studies which explore the hypothesis that endoneurial hypoxia is a major component of the pathogenetic mechanisms of diabetic peripheral neuropathy, and that peripheral neuropathy leads to structural changes in the diabetic foot. Microvascular blood flow and rheology were studied in three age and sex matched groups; diabetic patients with and without neuropathy, and non-diabetic control subjects. Peroneal nerve motor conduction velocity was significantly associated with transcutaneous oxygen tension, r=0.6.p<0.001. No significant differences in rheological parameters were found between non-neuropathic diabetic patients and controls, but significant adverse changes were found in rheological parameters, prostacyclin levels and fibrinolysis, in diabetic patients with neuropathy, in the absence of other complications. Peroneal nerve motor conduction velocity was measured in 10 non-diabetic and 6 diabetic patients before and after unilateral femoro-popliteal bypass surgery to assess the effect of improving tissue blood flow on nerve function. The contralateral leg served as a control. Restoring tissue oxygenation was associated with significant improvements in peroneal conduction velocity in both non-diabetic and diabetic patients, which may suggest new therapeutic strategies for peripheral neuropathy in man. The effects of diabetic neuropathy on the foot were examined by a radiographic survey of the prevalence of bone and soft tissue changes in the feet of diabetic patients and normal controls. This demonstrated that medial arterial calcification is significantly associated with peripheral neuropathy, making the use of ankle pressure indices unreliable in neuropathic patients. It also found an higher than previously recognised prevalence of traumatic and Charcot fractures amongst neuropathic diabetic patients. Further work demonstrated that Charcot patients have a global neurological impairment when compared to matched neuropathic patients without Charcot changes, and significantly reduced bone mineralisation, a possible predisposing factor for the fractures which often initiate the destructive phase of a Charcot joint. Finally, a new treatment for acute Charcot neuroarthropathy, intravenous Pamidronate, was evaluated, and proved effective in reducing the increased bone turnover, swelling and discomfort associated with the Charcot process.

This thesis is concerned with the design and building of a foot pressure system capable of measuring the pressure distribution underneath the diabetic foot. The system is developed to have a higher resolution and be more cost-effective than existing commercial systems. The biomechanics of the foot and ankle is explained in detail, providing an explanation for the relationship between high pressures and ulcerations. Various techniques of measuring foot pressure are reviewed, providing a thorough understanding of the advantages and disadvantages of each technique. The system developed uses the technique of interferometry, which is discussed in detail, explaining why the Fizeau Interferometer technique was chosen over other interferometer techniques. A number of materials were tested as to their suitability to be used as the pressure plate in the system i.e. compression/force relationship. From the results 'Perspex' was found to be the most suitable material. Two fringe-processing software packages were tested i.e. Fringe Processor 2 and Fringe Pattern Analysis (FRAN), with Fringe Processor 2 being chosen for this research. A graphical user interface for image display was created in order to display and analyse the various pressure images. Three prototypes were implemented. The first used a variation on the Fizeau interferometer, the second used a variation on the Twyman Green interferometer, whilst the third improved on the use of the variation of the Fizeau interferometer. By analysing the advantages and disadvantages of each prototype, the 3 rd prototype was chosen as the most suitable for achieving the aims and objectives of this research. This prototype was subjected to various tests i.e. resolution, measurable area, repeatability, calibration, short term reliability and sensitivity to heat. Various normal and pathological foot measurements were taken and analysed, and the effectiveness of the image display graphical user interface tested. The main contribution of this thesis is the use of interferometry to measure pressure. This in turn provides a foot pressure system, which has extremely high resolution and accuracy. The simple nature of the new pressure system also means that the entire system is very cost effective.

Class of 2010 Abstract
OBJECTIVES:The main purpose of this study was to review recent and good quality studies of the antimicrobial therapy of for moderate to severe (“limb threatening”) DFI. The analysis of these studies was to conclude with one or two “standard” approach to the routine management of this clinical entity. METHODS: This literature review study consisted of an evaluation of clinical trials that compare two or more active systemic antimicrobial regimens for the treatment of moderate to severe (i.e., “limb-threatening”) diabetic foot infections in human patients. Literature sources were identified primarily from OVID MEDLINE, but also included additional tertiary sources. The primary criteria for the clinical studies were: prospective, controlled, randomized and investigator blinded. Studies had to be published after the year 2003, and be available in full-text in English. RESULTS: Ultimately, only four studies were found that met the criteria for consideration. Trials differed in numerous features. All four studies were sponsored by the manufacturer of one of the comparator drugs. Three of the four were non-inferiority design. Evidence is lacking that any of the suggested regimens are superior. CONCLUSIONS: Instead of meeting our original goal of concluding that one or two regimens could be the “standard” management of DFI, we were limited to commentary on the quality and applicability of the current literature on this clinical entity. Numerous suggestions for improvement in the clinical information provided by DFI studies were offered. We eagerly anticipate the publication of the updated IDSA guideline document on DFI.

Recently the development of Patient-specific models (PSMs) tailored to patient-specific data, has gained more and more attention in clinical applications. PSMs could represent a solution to the growing awareness of personalized medicine which allow the realization of more effective rehabilitation treatments designed on the subject capabilities. PSMs have the potential of improving diagnosis and optimizing clinical treatments by predicting and comparing the outcomes of different approaches of intervention. Furthermore they can provide information that cannot be directly measured, such as muscle forces or internal stresses and strains of the bones. Given the considerable amount of diseases affecting motor ability, PSMs of the lower limbs have been broadly addressed in literature. Two techniques are mostly used in this area: musculoskeletal (MS) modeling and finite element (FE) analysis. (MS) models represent a valuable tool, as they can provide important information about the unique anatomical and functional characteristics of different subjects, through the computation of human internal variables, such as muscle activations and forces and joint contact forces. The flexibility and adaptability of FE analysis makes it a perfect solution to model biological geometries and materials and to simulate complicated boundary and loading conditions. Accurate and descriptive FE models would serve as an excellent tool for scientific and medical research. Furthermore they could be used in clinical settings if combined with medical imaging, in order to improve patient care. Several 3-dimensional (3D) foot FE models were recently developed to analyze the biomechanical behavior of the human foot and ankle complex that is commonly studied with experimental techniques like stereophotogrammetry, force and plantar pressure plates. In this context, many gait analysis protocols have been proposed to assess the 3D kinetics, kinematics and plantar pressure distribution. This evaluation has shown to be useful in characterizing the foot biomechanics in different pathologies like the diabetic foot. Diabetic foot is an invalidating complication of diabetes mellitus, a chronic disease frequently encountered in the aging population. It is characterize by the development of ulcers which can lead to amputation. Models for simulations of deformations and stresses in the diabetic plantar pad are required to predict high risk areas on the plantar surface and can be used to investigate the performance of different insoles design for optimal pressure relief. This work represents a first effort towards the definition of a more complete PSM which combining both a MS model and a FE model, can increase the understanding of the diabetic foot pathology. To achieve this objective, several limitations and issues have been addressed. As first, MS models of diabetic and control subjects were developed using OpenSim, to estimate muscle forces. The objective was to evaluate whether the diabetic population exhibit lower limb muscle strength deficits compared to the healthy one. Subjects routine gait analysis was performed and lower limb joints kinematics, kinetics, time and space parameters estimated by means of a modified version of the IORgait protocol. 3D lower limb joints kinematics and kinetics was also calculated with OpenSim. Both methodologies were able to highlight differences in joint kinematics and kinetics between the two populations. Furthermore MS models showed significant differences in healthy muscle forces with respect to the diabetic ones, in some of the muscles. This knowledge can help the planning of specific training in order to improve gait speed, balance, muscle strength and joint mobility. After the use of MS models proved to be applicable in the diabetic population, the next step was to combine them with foot FE models. This was done in two phases. At first the impact of applying the foot joints contact forces (JCFs) obtained from MS models as boundary condition on the foot FE models was verified. Subject specific geometries from MRI were used for the development of the foot FE models while the experimental plantar pressures acquired during gait were used in the validation process. A better agreement was found between experimentally measured and simulated plantar pressure obtained with JCFs than with the experimentally measured ground reaction forces as boundary conditions. Afterwards the use of muscles forces as boundary condition in the FE simulations was evaluated. Subject-specific integrated and synchronized kinematic-kinetic data acquired during gait analysis were used for the development of the MS models and for the computation of the muscle forces. Muscle insertions were then located in the MRI and correspondent connectors were created in the FE model. FE subject-specific simulations were subsequently run with Abaqus by conducting a quasi-static analysis on 4 gait cycle phases and adopting 2 conditions: one including the muscle forces and one without. Once again the validation of the FE simulations was done by means of a comparison between simulated and experimentally measured plantar pressures. Results showed a marked improvement in the estimation of the peak pressure for the model that included the muscles. Finally, an attempt towards the definition of a parametric foot finite element model was done. In fact, despite the recent developments, patient-specific models are not yet successfully applied in a clinical setting. One of the challenges is the time required for mesh creation, which is difficult to automate. The development of parametric models by means of the Principle Component Analysis (PCA) can represent an appealing solution. In this study PCA was applied to the feet of a small cohort of diabetic and healthy subjects in order to evaluate the possibility of developing parametric foot models and to use them to identify variations and similarities between the two populations. The limitations of the use of models have also been analyzed. Their adoption is indeed limited by the lack of verification and validation standards. Even using subjects’ MRI or CT data for the development of FEM together with experimentally acquired motion analysis data for the boundary and loading conditions, the subject specifity is still not reached for what regards all the material properties. Furthermore it should be considered that everything relies on algorithm and models that would never be perfectly representing the reality. Overall, the work presented in this thesis represents an extended evaluation of the possible uses of modeling techniques in the diabetic foot prevention, by considering all the limitations introduced as well as the potential benefits of their use in a clinical context. The research is organized in six chapters: Chapter 1 - provides a background on the modeling techniques, both FE modeling and MS modeling. Furthermore it also describes the gait analysis, its instrumentation and some of the protocols used in the evaluation of the biomechanics of the lower limbs; Chapter 2 - gives a detailed overview of the biomechanics of the foot. It particularly focuses on the diabetes and the diabetic foot; Chapter 3 - introduces the application of MSs for the diabetic foot prevention after a brief background on the techniques usually chosen for the evaluation of the motor impairments caused by the disease. Aim, material and methods, results and discussion are presented. The complete work flow is described, and the chapter ends with a discussion on new key findings and limitations. Chapter 4 – reports the work done to combine the use of musculoskeletal models with foot FEMs. At first the impact of applying the foot joints contact forces obtained from MS models as boundary condition on the foot FEMs is verified. Then the use of muscles forces (again obtained from MS models) as boundary condition in the FE simulations is evaluated. For both studies a brief background is presented together with the methods applied, the results obtained and a discussion of novelties and drawbacks. Chapter 5 – explores the possibility of defining a parametric foot FEM applying the Principle Component Analysis (PCA) on the feet of a small cohort of diabetic and healthy subjects. A background on the importance of patient specific models is presented followed by material and methods, results and discussion of what obtained with this study. Chapter 6 - summarizes the results and the novelty of the thesis, delineating the conclusions and the future research paths.
Recentemente lo sviluppo di modelli specifici di un paziente (PSM), cioè creati a partire dai suoi dati, ha guadagnato sempre più attenzione per le possibili applicazioni cliniche. Questi modelli potrebbero, infatti, rappresentare una soluzione alla crescente consapevolezza che la medicina deve essere personalizzata al fine di ottenere un trattamento riabilitativo più efficace e disegnato ad hoc sulle capacità soggetto. Gli PSM hanno il potenziale di migliorare la diagnosi e di ottimizzare la terapia riabilitativa, data la loro capacità di prevedere e di confrontare i risultati di diversi approcci d’intervento. Inoltre essi sono in grado di fornire informazioni che non possono essere direttamente misurate, quali forze muscolari o tensioni interne alle ossa. Data la notevole quantità di malattie che causano deficit motori, gli PSM sono stati ampiamente affrontati in letteratura. Le due tecniche per lo più utilizzate in questo settore sono la modellazione muscoloscheletrica (MS) e la modellazione agli elementi finiti (FE). I modelli MS rappresentano uno strumento prezioso, poiché possono fornire importanti informazioni sulle caratteristiche anatomiche e funzionali dei diversi soggetti, attraverso il calcolo di variabili interne come attivazioni muscolari e forze di contatto alle articolazioni. La flessibilità e l'adattabilità dell'analisi FE la rende una soluzione ideale per modellare geometrie e materiali biologici e per simulare condizioni al contorno e di carico complicate. Modelli FE (FEM) precisi e descrittivi potrebbero dimostrarsi un ottimo strumento per la ricerca scientifica e medica. Inoltre, potrebbero essere utilizzati in ambito clinico se combinati con l'imaging medico, al fine di migliorare la cura del paziente. Diversi FEM a 3 dimensioni (3D) del piede sono stati recentemente sviluppati per analizzare il comportamento biomeccanico del complesso piede-caviglia che è comunemente studiato con tecniche sperimentali come la stereofotogrammetria, le piattaforme di forza e di pressione. In questo contesto, sono stati proposti molti protocolli per l'analisi del cammino al fine di valutare la cinematica, la cinetica e la distribuzione della pressione plantare in 3D. Questa valutazione si è dimostrata utile per caratterizzare la biomeccanica del piede in diverse patologie come il piede diabetico. Il piede diabetico è una complicanza invalidante del diabete mellito, una malattia cronica sempre più frequente nella popolazione anziana. Esso è caratterizzato dallo sviluppo di ulcere che possono portare all'amputazione. Modelli per la simulazione di deformazioni e sollecitazioni nel tessuto plantare diabetico devono essere in grado di prevedere quali sono le zone ad alto rischio per la formazione di ulcere sulla superficie plantare e possono essere usati per studiare le prestazioni di diverse solette nell'alleviare la pressione. Questo lavoro rappresenta un primo sforzo verso lo sviluppo di uno PSM più completo che combinando un modello MS a un FEM, può aumentare la comprensione della patologia del piede diabetico. Per raggiungere quest’obiettivo, numerose limitazioni e problematiche sono state analizzate e risolte. Innanzitutto, modelli MS di soggetti sani e diabetici sono stati sviluppati usando OpenSim al fine di stimare le forze muscolari. L'obiettivo era di valutare se la popolazione malata presenta deficit di forza muscolare negli arti inferiori rispetto a quella sana. I soggetti sono stati sottoposti a un'analisi del cammino e la cinematica e la cinetica degli arti inferiori sono state stimate per mezzo di una versione modificata del protocollo IORgait. La cinematica e la cinetica 3D delle articolazioni degli arti inferiori sono state calcolate anche con OpenSim. Entrambe le metodologie sono state in grado di evidenziare alcune differenze di cinematica e cinetica articolare tra le due popolazioni. I modelli MS hanno inoltre evidenziato differenze nelle forze muscolari dei soggetti sani rispetto a quelli diabetici. Questa conoscenza può aiutare nella pianificazione di terapie riabilitative specifiche per i pazienti diabetici al fine di migliorare la velocità, l'equilibrio, la forza muscolare, l’andatura e la mobilità articolare. Dopo aver dimostrato l'applicabilità dei modelli MS nella popolazione diabetica, il passo successivo è stato quello di combinarli con FEM del piede. Ciò è stato fatto in due fasi. In un primo momento l'impatto dell'applicazione delle forze di reazione dell'articolazione del piede, ottenute dai modelli MS, come condizione al contorno per modelli FE del piede è stata verificata. Le geometrie specifiche del soggetto, ricavate da MRI, sono state utilizzate per lo sviluppo dei FEM del piede mentre le pressioni plantari sperimentalmente acquisite durante la deambulazione sono state utilizzate nel processo di validazione. Un miglior accordo tra pressione misurata sperimentalmente e pressione simulata è stato ottenuto utilizzando, come condizioni al contorno, le forze di reazione alla caviglia rispetto alle forze di reazione del suolo sperimentalmente simulate. Dopodiché l'uso di forze muscolari come condizione al contorno nelle simulazioni FE è stata valutata. Dati di cinematica e cinetica acquisiti in sincrono durante l'analisi del cammino sono stati utilizzati per lo sviluppo di modelli MS e per il calcolo delle forze muscolari. Le inserzioni muscolari sono state poi trovate nelle immagini di risonanza magnetica e i connettori corrispondenti sono stati creati nel FEM. Le simulazioni FE specifiche del soggetto sono state in seguito eseguite con il software Abaqus conducendo un'analisi quasi statica su quattro fasi del ciclo del passo e adottando due condizioni di carico: una che comprendeva le forze muscolari e una senza. Ancora una volta la validazione delle simulazioni FE è stata fatta per mezzo di un confronto tra le pressioni plantari simulate e misurate sperimentalmente. I risultati hanno mostrato un miglioramento marcato nella stima del picco di pressione nel modello che includeva i muscoli. Infine è stato fatto un tentativo per la definizione di un modello agli elementi finiti del piede parametrico. Infatti, nonostante i recenti sviluppi, gli PSM non sono ancora stati applicati con successo in un ambiente clinico. Una delle possibili spiegazioni è il tempo necessario per la creazione della mesh, operazione che è di difficile automatizzazione. Lo sviluppo di modelli parametrici mediante l'analisi in componenti principali (PCA) può rappresentare una soluzione accattivante. In questo studio la PCA è stata applicata alla geometria dei piedi di una piccola coorte di soggetti diabetici e sani per valutare la possibilità di sviluppare modelli parametrici del piede e di utilizzarli per identificare varianti e analogie tra le due popolazioni. Anche i limiti imposti dall'uso di modelli sono stati analizzati. La loro adozione è, infatti, limitata dalla mancanza di standard di verifica e validazione. Anche utilizzando l'MRI per lo sviluppo di un FEM, e dati sperimentali di analisi del movimento per le condizioni al contorno e di carico, la specificità del soggetto non è mai perfettamente raggiunta ad esempio per quanto riguarda le proprietà dei materiali. Inoltre bisognerebbe considerare che tutto si appoggia su algoritmi e modelli che non saranno mai in grado di rappresentare perfettamente la realtà. Nel complesso, il lavoro presentato in questa tesi rappresenta una valutazione estesa dei possibili usi di tecniche di modellazione nella prevenzione del piede diabetico, considerando tutte le limitazioni introdotte e i potenziali vantaggi del loro utilizzo in un contesto clinico. La ricerca si articola in sei capitoli: Capitolo 1 - fornisce uno sguardo generale sulle tecniche di modellazione, sia modellazione agli elementi finiti sia modellazione muscoloscheletrica. Inoltre descrive l'analisi del cammino, la strumentazione richiesta e i protocolli sviluppati per l'analisi degli arti inferiori. Capitolo 2 - fornisce una panoramica dettagliata della biomeccanica del piede concentrandosi in particolare sul diabete e il piede diabetico; Capitolo 3 - introduce l'applicazione dei modelli MS per la prevenzione del piede diabetico dopo una breve introduzione sulle tecniche più comuni utilizzate nella valutazione dei deficit motori causati dalla malattia. Obiettivi, materiali e metodi, risultati e discussione finale sono presentati. Il flusso di lavoro completo è descritto, e il capitolo si finisce con una discussione sulle nuove scoperte e sulle limitazioni. Capitolo 4 - riporta il lavoro fatto per combinare l'uso di modelli muscoloscheletrici con FEM del piede. In un primo momento è verificato l'impatto dell'applicazione delle forze di contatto all'articolazione del piede, ottenute dai modelli MS, come condizione al contorno nei FEM del piede. Di seguito è valutato l'uso delle forze muscolari (ancora una volta ottenute dai modelli MS) come condizione al contorno nelle simulazioni FE. Per entrambi gli studi è presentata una breve introduzione insieme ai metodi applicati, ai risultati ottenuti e a una discussione sulle novità introdotte e sui limiti. Capitolo 5 - esplora la possibilità di definire un FEM del piede parametrico applicando l' analisi delle componenti principali (PCA) ai piedi di una piccola coorte di soggetti diabetici e sani. Una panoramica sull'importanza di modelli specifici dei pazienti è presentata seguita da materiali e metodi, risultati e discussione di ciò che è stato ottenuto con questo studio. Capitolo 6 - riassume i risultati e la novità della tesi, delineando le conclusioni e i percorsi di ricerca futuri.

Introduction: Diabetic foot (DF) is a common complication in patients with diabetes mellitus. Due to arterial abnormalities and diabetic neuropathy, as well as a tendency to delayed wound healing, infection or gangrene of the foot is relatively common. Early study indicated Si-Miao-Yong-An (SMYA) decoction is the most chosen Chinese herbal formulae in the treatment of DF. The aim of this study is to assess the quality of current evidence, and systematic review the effectiveness and safety of SMYA decoction for the treatment of DF. Method: (1) Search strategy: a special protocol was designed, and electronic databases and hand-search materials were used for screening eligible trials. (2) Inclusive criteria: randomized controlled trials (RCTs) to examine the efficacy and/or safety of SMYA decoction in DF treatments were valid. (3)Data analysis: the Jadad’s scale was used to assess the quality of eligible trials. Result: Total 23 RCTs met the inclusion criteria. Among those, 1341 patients are involved, 702 patients were treated by SYMA decoction. 22 trails using SMYA decoction combined WM claimed that they showed a statistically significant advantages over the treatments using WM alone in reducing DF symptoms. Only 1 RCT reported adverse events related to SMYA decoction, but less than WM treatment. Conclusion: All available evidence points to the fact that SMYA decoction may benefit to those diabetes patients with foot problem. However, due to the poor quality of included trials, more high-quality trials are required to substantiate or refute these early findings.

Diabetes is a condition that can lead to foot ulcers that often progress to amputation of a limb. Providing patients with education about foot care is crucial because it can help to prevent or minimize the incidence of foot ulcer development and amputation of a limb. Foot care education as a strategy not only empowers patients with proper foot care knowledge and skill to support and motivate self-care but can also enhance the partnership between the provider and patient. The purpose of this quality improvement project was the implementation of a sustainable evidence-based foot care program for adult patients with diabetes as a routine organizational protocol for quality improvement in diabetic care in a primary care clinic. The question for this project was: How does the implementation of an evidence-based diabetic foot care protocol impact the health outcomes of diabetic patients in a primary care clinic? Orem’s self-care deficit nursing theory and the logic model for evidence-based practice were used to guide this DNP project. The research method for the quality improvement project was a review of the literature. The participants were staff and adults with diabetes at the primary care clinic. The results of the chart review showed that 80% of the charts included documented foot assessments and patient education, which was an improvement when compared to 40% pre-implementation of the foot care program. The program has improved the foot health knowledge and skills of clinicians and people with diabetes and has also helped to reduce the burden of healthcare costs related to the lower incidence of hospitalization for the treatment of wounds and amputation associated with complications of diabetes.

Primary aetiologic factors of diabetic foot disease include peripheral neuropathy and peripheral vascular disease. Assessment of circulation, neuropathy, and foot pressure is employed routinely to determine the risk of foot ulceration in the patient with diabetes mellitus. Routine neuropathic evaluation includes assessment of sensory loss in the plantar skin of the foot using both the Semmes Weinstein monofilament and the biothesiometer. Progressive degeneration of sensory nerve pathways is thought to affect thermoreceptors and mechanoreceptors. However, thermological measurements of the foot to assess responses to thermal stimuli and cutaneous thermal discrimination threshold are relatively uncommon. Recent improvements in liquid crystal technology (LCT) including insensitivity to pressure, faster response times, lower cost and fast image acquisition offer potential for routine thermographic assessment of the diabetic foot. The present study was designed to evaluate if an association exists between abnormal plantar thermal images and sensory loss under conditions of normal loading. The system comprises a robust measurement platform, thermochromic liquid crystal polyester sheet (TLC), instrumentation and analysis software. In vitro calibration was performed to characterise three physical forms of TLC on the basis of linearity, hysteresis, pressure sensitivity and response time. An in vivo pilot evaluation study of the system was performed using three sub-groups (i) neuropathic diabetic (n=30), (ii) non neuropathic diabetic (n=30) and (iii) a healthy control group (n=30). The principal results of this study indicate raised plantar temperatures for the diabetic groups at baseline and post stress relative to the control group. Furthermore, poor recovery response to thermal stimulus in the neuropathic diabetic group suggests degeneration of thermoreceptors. Thus by assessing the thermal parameters at the same sites as that of sensory testing, the new LCT based approach appears capable of providing an alternative confirmation of clinical neuropathy and offers potential as an improved method compared to existing techniques.

Background: Diabetic foot ulcers are the result of multiple complications from hyperglycemia and lead to poor quality of life and high healthcare costs. The annual diabetes foot screening exam (ADFSE) and prevention interventions can reduce DFUs up to 75%. In 2015, 71% of the US population received the ADFSE. Objectives: The main objectives of this dissertation were: 1) to determine the association between adherence to diabetes self-management behaviors and the ADFSE, 2) to determine the association between concordant and discordant comorbidities and the ADFSE and 3) to determine the association between the performance of diabetes preventive care processes, number of office visits for diabetes and the completion of the ADFSE. Methods: Three cross-sectional studies used data from the 2015 Behavioral Risk Factor Surveillance System. Logistic regression models were evaluated to assess the association between the self-management behaviors and the ADFSE. Structural equation modeling (SEM) was used to assess the simultaneous, direct effects of concordant and discordant comorbidity loads on the ADFSE and the performance of diabetes preventive care processes and the number of office visits for diabetes care on the ADFSE. Results: In 2015, between 78.2% and 80.4% of the US population with diabetes received the ADFSE. Performance of the ADFSE was 77% less likely (OR: 0.33, 95%CI: 0.25-0.44) in those who do not perform self-foot inspections and 40% (OR: 0.59, 95%CI: 0.45-0.76) less likely in those who have never received the pneumococcal vaccination. Receiving the ADFSE was 50-80% less likely in patients who do not self-monitor blood glucose at least one time per day, depending on insulin use and receipt of diabetes education. Neither concordant comorbidities (β=0.226, p=0.086) nor discordant comorbidities (β=0.080, p=0.415) had a direct association with the performance of the ADFSE. The collection of preventive care processes demonstrated a 7% (OR: 1.07, 95% CI: 1.05-1.10) increase in the likelihood the ADFSE was performed Conclusions: Performance of the ADFSE may be improved through multiple types of interventions. Patient-based interventions to increase adherence to self-management behaviors is one route. Programs to improve overall diabetes care in the clinical setting may also help to further improve completion of the ADFSE.

Diabetic foot ulcers (DFUs) are one common and severe complication of diabetes, showing impaired wound healing. Peripheral arterial disease (PAD), which is common in diabetes, increases the severity of DFUs leading to delayed or unsuccessful healing. Prolonged inflammation is one of the likely contributors to this, with an imbalance in macrophage phenotypes seen in diabetes. Monocytes, precursors to macrophages, express M1/M2 macrophage markers indicating monocyte skewing to a particular macrophage phenotype begins in the circulation. Whether the presence of DFU is associated with monocyte M1-skewing and the presence of PAD further influences this is not known. The main aim of this study was to investigate the effect of PAD on the inflammatory profile of circulating monocytes and ulcer macrophages in DFU patients, as well as determining whether monocyte/macrophage profile relates to healing parameters. Blood and ulcer biopsy samples were collected from DFU patients with and without PAD. Whole blood flow cytometry was used to determine monocyte subset proportions and M1-skewing, which was also compared with historical data from healthy controls. Immunohistochemistry was used to detect M1/M2 ulcer macrophages. DFU patients in general had a higher proportion of intermediate monocytes than controls (p=0.042) and DFU/PAD had more intermediates than DFU/NoPAD (p=0.02), suggesting PAD worsens this imbalance. M1-skewing of monocytes was higher in DFU/PAD patients than DFU/NoPAD group (p=0.046) in addition to strong M1 skewing in DFU patients in general (p<0.001). DFU/PAD patients had more M1 macrophages in their ulcers than DFU/NoPAD patients (p=0.04) and their M1/M2 ratio correlated positively with ulcer cross-sectional area (p=0.01). This study highlighted the enhanced inflammatory profile in DFU patients, particularly those complicated with PAD. These monocyte and macrophage alterations, may contribute to the delay in wound healing typical of this group.

The overall aim was to study self-care, foot problems and self-perceived health in 150 consecutively invited Tanzanian diabetic patients and to compare them with gender- and age-matched Swedish diabetic patients (n=150) from a middle Sweden area. The main study was cross-sectional and took place at a diabetes clinic in Dar es Salaam. All patients answered questions about their self-care satisfaction, diabetes knowledge and skills, and educational needs. Foot examination also included questions about foot-care and perceived foot problems. The patients' health was assessed using the SF-36 general health questionnaire. The Swahili version of SF-36 was pre-tested in 518 Tanzanian diabetic patients showing an acceptable validity and reliability. Glycaemic control was measured by HbA1c. The results indicated that 45% of Tanzanians and 43% of the Swedes reported satisfaction with their self-care. The Tanzanian patients reported that following doctor's advice was the most important factor necessary for feeling well, whereas the Swedish patients emphasised diet and exercise. Lack of drugs and education were reasons of dissatisfaction in the Tanzanian group, whilst the Swedes were dissatisfied with their own behaviour. None of the Tanzanians monitored their blood glucose themselves, whilst 50% of the Swedes did it on a daily or weekly basis. Significantly more Swedes than Tanzanians knew the interaction between insulin, food and exercises, and how to manage hyperglycaemia and hypoglycemia. The Tanzanians wanted more education about diabetes, treatment and injection technique, whereas the Swedes wanted education about psychological aspects of diabetes, foot-care and oral anti-diabetic treatment. Foot problems reported in the Tanzanian group were pain, numbness and pricking sensations, whereas the Swedes reported ingrown toenails, pain and fissures. Seven Tanzanians and one Swede had foot ulcers. Twenty Tanzanians and 103 Swedes reported to inspect their own feet. The Tanzanians had significantly poorer self-perceived health and glycaemic control than the Swedish patients. A follow-up study was performed with the Tanzanian group of patients after two years. Many patients did not return for the second investigation and 70 patients were re-assessed. They showed an improved self-perceived health and a significant decrease in HbA1c-value. In conclusion the results indicated that Tanzanian patients needed better access to a continuous and regular supply of diabetes drugs. Furthermore the Tanzanians' burden of diabetes influenced their possibilities to work, whilst Swedish patients were hindered in social activities. In both countries the importance of regular foot inspections of the patients' feet should be emphasised. Glycaemic control and self-perceived health seemed to be poorly related and for that reason diabetes nurse specialists need to use both measures in order to guide the patients towards the goals experiencing a good health despite having diabetes.

Soft tissue infection in a diabetic foot with an ulcer is often clinically obvious but the diagnosis of osteomyelitis underlying a diabetic foot ulcer is challenging. It has been calculated that there are over 1 million amputations worldwide for diabetes related complications every year, many preceded by an ulcer complicated by osteomyelitis.
This research encompasses two studies attempting to add to the ways in which osteomyelitis is diagnosed.
The first was examining the role of inflammatory blood markers in recognising and separating ulcers with cutaneous infection from both suspected and proven osteomyelitis. The response of the body to produce these markers when an injury occurs is well known but arguments exist as to the capacity of the individual with diabetes to do so. Despite the recognition and allowance for common confounding factors no trend was found. This study may have been more difficult than originally thought due to the many interactions of the diseased state of diabetes, the drugs used to control it and the many other confounders that would have influenced the inflammatory process and as such the level of the markers.
The second study was comparing a new form of scanning technique (SPECT/CT) to the technique most commonly used as a ‘gold standard’ – MRI. The results of each type of scan were compared to the clinical diagnosis and each other. The SPECT/CT scan appears to show some good results and may be a more suitable scan for individuals who are unable to have a MRI for example due to the need to introduce a renally excreted drug to help make the images clearer but it does mean introducing a small amount of radiation into the individual.

Background: Screening for Diabetic Foot Ulcers in the primary care setting can lead to good outcomes for patient and prevent diabetic foot ulcers. Annual screening can detect high-risk patients who are more prone to develop foot ulcers. These patients should then be screened with every visit to prevent a major complication of diabetes, which is a diabetic foot ulcer. Objective: To promote foot examinations in the primary care setting for patients with diabetes who are at high risk of developing a diabetic foot ulcer. Design: A quantitative methodology applying a quality improvement (QI) model was created to examine primary care providers’ knowledge, barriers, and facilitators to foot examination in high-risk patients with diabetes. Participants: Five primary care providers (physicians and nurse practitioners). Setting: A physician owned primary care office in Glendale, Arizona. Measurement: A 19-item survey comprised of Likert-type and open-ended questions was created. Analysis was conducted in Excel. Results: The providers demonstrated adequate baseline knowledge about high-risk patients and foot examinations. Opportunities for improvement were identified and included a system to prompt performance of foot exams and clarification as to who is responsible for performing the foot exams. Potential solutions for improvement were discussed with the clinic representatives on the QI team. Conclusion: Diabetes is a chronic condition and strategies to prevent complications, particularly diabetic foot ulcers, improve patient outcomes and contribute to the delivery of high quality care. As a result of this project, clarification about responsibility for foot examinations and recommendations for a process improvement to prompt performance of foot exams will be made to the practice.

xi, 67 p. : ill. A print copy of this title is available through the UO Libraries under the call numbers: KNIGHT RD756.42 .E83 2007
Partial foot amputation is becoming more prevalent and costly and if not treated correctly can lead to higher levels of amputation. Despite this, partial foot orthotic research and development has been inadequate. Furthermore, in order to contribute to improved orthotic management, there is a need to understand the biomechanical discrepancies during gait. Biomechanical goals of orthotic fitting include normalizing the three functional impairments of the transmetatarsal amputee. The first goal is to improve balance, the second is to normalize the toe-off phase of gait, and the third goal involves supporting the plantar surface of the foot to evenly distribute pressure. In this study, all subjects were evaluated with a below-ankle condition and an above-ankle condition. The below-ankle condition consisted of a total contact foot orthosis fitted into Drew' shoes with rocker bottom soles. The below-ankle orthosis was then fitted with a Blue Rocker© ankle foot orthosis and gait was re-evaluated as the above-ankle orthotic gait condition. Three specific goals were proposed in this study: 1) to determine the differing, if any, effects on balance and vertical ground reaction symmetry during level walking and obstacle crossing between the two orthotic designs, 2) to determine the plantar pressure distribution differences between a below-ankle and an above-ankle design, 3) to learn about patient preferences to provide realistic feedback for quality patient care. We hypothesized that improved balance, symmetry and distribution of pressure would occur with the above-ankle design in individuals with greater disability.
Adviser: Li-Shan Chou

Adults with diabetes-related foot ulcers (DFUs) are at high risk for frequent hospitalisation, non-traumatic amputation, and increased mortality rate. Offloading is the primary recommended treatment to manage DFUs. This research aimed to understand patients’ adherence to wearing removable offloading devices by conducting a mixed-methods investigation. The results revealed that patients with DFUs have low adherence to wearing their removable offloading devices. A combination of psychosocial, physiological, and environmental factors was identified to impact adherence. Therefore, clinicians should firstly adopt non-removable offloading devices. However, when removable offloading devices are needed, the adherence factors found in this research should be considered.

Background: Repetitive stress on the neuropathic plantar foot is the primary cause of diabetic foot ulcers. After healing, recurrence is common. Modulating plantar pressure has been associated with extension of ulcer free days. Therefore, the goal of this study was to determine the effects of an injectable allograft adipose matrix in providing a protective padding and reducing the pressure in the plantar foot. Methods: After healing his recurrent ulcer using total contact casting, a 71-year-old man with a 9-year history of recurrent diabetic foot ulcers was treated with injection of allograft adipose matrix, procured from donated human tissue. This was delivered under postulcerative callus on the weight-bearing surface of the distal end of the first ray resection. As is standard in our clinic for tissue augmentation procedures, our patient underwent serial plantar pressure mapping using an in-shoe pressure monitoring system. Results: There was a 76.8% decrease in the mean peak pressure due to the fat matrix injected into the second metatarsal region and a 70.1% decrease in mean peak pressure for the first ray resection at the site of the postulcerative callus. By 2 months postoperatively, there was no evidence of residual callus. This extended out to the end of clinical follow-up at 4 months. Conclusion: The results from this preliminary experience suggest that allograft adipose matrix delivered to the high risk diabetic foot may have promise in reducing tissue stress over pre- and postulcerative lesions. This may ultimately assist the clinician in extending ulcer-free days for patients in diabetic foot remission.

Were he alive today, would Louis Pasteur still champion culture methods he pioneered over 150 years ago for identifying bacterial pathogens? Or, might he suggest that new molecular techniques may prove a better way forward for quickly detecting the true microbial diversity of wounds? As modern clinicians faced with treating complex patients with diabetic foot infections (DFI), should we still request venerated and familiar culture and sensitivity methods, or is it time to ask for newer molecular tests, such as 16S rRNA gene sequencing? Or, are molecular techniques as yet too experimental, non-specific and expensive for current clinical use? While molecular techniques help us to identify more microorganisms from a DFI, can they tell us ‘who done it?', that is, which are the causative pathogens and which are merely colonizers? Furthermore, can molecular techniques provide clinically relevant, rapid information on the virulence of wound isolates and their antibiotic sensitivities? We herein review current knowledge on the microbiology of DFI, from standard culture methods to the current era of rapid and comprehensive ‘crime scene investigation' (CSI) techniques.

Diabetic foot is a foot that exhibits any pathology that results directly from diabetes mellitus or any long term (chronic) complication of diabetes mellitus. Diabetic Foot syndrome exhibits several characteristic diabetic foot pathologies such as; diabetic foot ulcer and neuropathic osteoarthropathy which may require surgical intervention for correction.