Barriers to implementing foot care.

The foot of diabetic patients can be affected by ulceration, infection, and gangrene and is a source of major morbidity and mortality; yet, it has been neglected by health-care services. In recent years, however, the level of interest and knowledge has grown considerably, with an improving evidence base for clinical practice and the development of international consensus and guidelines that define strategies for diagnosis and appropriate treatment. Nevertheless, there are numerous barriers to the implementation of universal good care, involving attitudes and beliefs of doctors, other health-care professionals, and patients, and the structure of health-care systems, which conspire to prevent diabetic patients from receiving the appropriate multidisciplinary care they desperately need. Before diabetic foot care reaches the level desired by specialists in the field, these many barriers must be recognized and overcome. Sound and cost-effective strategies need to be developed. Policymakers and health-care professionals should work together to remove the obstacles and facilitate the provision of adequate diabetic foot care. The effect of diabetic foot disease and amputations will only be reduced if sufficient attention is paid to the necessary preventive measures.

Unresolved issues in the management of ulcers of the foot in diabetes.

Management of diabetic foot ulcers presents a major clinical challenge. The response to treatment is often poor and the outcome disappointing, while the costs are high for both healthcare providers and the patient. In such circumstances, it is essential that management should be based on firm evidence and follow consensus. In the case of the diabetic foot, however, clinical practice can vary widely. It is for these reasons that the International Working Group on the Diabetic Foot has published guidelines for adoption worldwide. The Group has now also completed a series of non-systematic and systematic reviews on the subjects of soft tissue infection, osteomyelitis, offloading and other interventions designed to promote ulcer healing. The current article collates the results of this work in order to demonstrate the extent and quality of the evidence which is available in these areas. In general, the available scientific evidence is thin, leaving many issues unresolved. Although the complex nature of diabetic foot disease presents particular difficulties in the design of robust clinical trials, and the absence of published evidence to support the use of an intervention does not always mean that the intervention is ineffective, there is a clear need for more research in the area. Evidence from sound clinical studies is urgently needed to guide consensus and to underpin clinical practice. It is only in this way that patients suffering with these frequently neglected complications of diabetes can be offered the best hope for a favourable outcome, at the least cost.

The development of global consensus guidelines on the management of the diabetic foot.

The future for diabetes is grave. Now described as the global epidemic of the 21st century, the increasing incidence of diabetes (in 2007 over 246 million people affected by diabetes) will place considerable strain on resources and will bring suffering to many if the preventative measures promoted by the International Diabetes Federation (IDF), the International Working Group on the Diabetic Foot (IWGDF) and other diabetes representative organizations are not put into effect. Ulcers of the foot in diabetes are a source of major suffering and cost. Investing in a diabetic foot care guideline can be one of the most cost-effective forms of healthcare expenditure, provided the guideline is goal-focused and properly implemented. The objective of the IWGDF, founded in 1996, is to develop guidelines that will reduce the impact of diabetic foot disease through cost-effective and quality healthcare, based on the principles of evidence-based medicine. Three IWGDF working groups were invited to write specific consensus guidelines on different subjects, according to the current standards of evidence based medicine. Therefore, for the first time, new 2007 texts were produced according to a systematic review of the literature, in order to inform protocols for routine care and to highlight areas which should be considered for further study. After reaching worldwide consensus, the review reports and specific guidelines were launched in May 2007.

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes.

The outcome of management of diabetic foot ulcers is poor and there is uncertainty concerning optimal approaches to management. We have undertaken a systematic review to identify interventions for which there is evidence of effectiveness. A search was made for reports of the effectiveness of interventions assessed in terms of healing, ulcer area or amputation in controlled clinical studies published prior to December 2006. Methodological quality of selected studies was independently assessed by two reviewers using Scottish Intercollegiate Guidelines Network (SIGN) criteria. Selected studies fell into the following categories: sharp debridement and larvae; antiseptics and dressings; chronic wound resection; hyperbaric oxygen (HBO); reduction of tissue oedema; skin grafts; electrical and magnetic stimulation and ultrasound. Heterogeneity of studies prevented pooled analysis of results. Of the 2251 papers identified, 60 were selected for grading following full text review. Some evidence was found to support hydrogels as desloughing agents and to suggest that a systemic (HBO) therapy may be effective. Topical negative pressure (TNP) may promote healing of post-operative wounds, and resection of neuropathic plantar ulcers may be beneficial. More information was needed to confirm the effectiveness and cost-effectiveness of these and other interventions. No data were found to justify the use of any other topically applied product or dressing, including those with antiseptic properties. Further evidence to substantiate the effect of interventions designed to enhance the healing of chronic ulcers is urgently needed. Until such evidence is available from robust trials, there is limited justification for the use of more expensive treatments and dressings.

Increased prevalence of catecholamine excess and phaeochromocytomas in a well-defined Dutch population with SDHD-linked head and neck paragangliomas.

OBJECTIVE: The aim of this study was to identify the prevalence of catecholamine excess and phaeochromocytomas in a well-defined population of people with hereditary head and neck paragangliomas. METHODS: We studied in a prospective follow-up protocol all consecutive patients referred to the Department of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands with documented head and neck paragangliomas and either a positive family history for paragangliomas or a proven SDHD gene mutation. Initial analysis included medical history, physical examination and the measurement of excretion of catecholamines in two 24-h urine collections. In the case of documented catecholamine excess iodinated meta-iodobenzylguanidine (123I-MIBG) scintigraphy and magnetic resonance imaging were done. RESULTS: Between 1988 and 2003, 40 consecutive patients (20 male and 20 female) with documented head and neck paragangliomas were screened. Biochemical screening revealed urinary catecholamine excess in 15 patients (37.5%). In nine of these 15 patients a lesion was found by 123I-MIBG scintigraphy. Exact localization by magnetic resonance imaging revealed phaeochromocytomas in seven of the 15 patients. One of the nine patients had an extra-adrenal paraganglioma. Histopathological examination in a subset of tumors displayed loss of heterozygosity of the wild-type SDHD allele in all cases. CONCLUSIONS: The prevalence of catecholamine excess (37.5%) and phaeochromocytomas (20.0%) is high in patients with familial head and neck paragangliomas. Therefore, patients with hereditary head and neck paragangliomas require lifelong follow up by biochemical testing for catecholamine excess.

Amputation as a marker of the quality of foot care in diabetes.

Strategic targets for the management of foot ulcers focus on reducing the incidence of amputation. While data on the incidence of amputation can be obtained relatively easily, the figures require very careful interpretation. Variation in the definition of amputation, population selection and the choice of numerator and denominator make comparisons difficult. Major and minor amputation have to be distinguished as they are undertaken for different reasons and are associated with different costs and functional implications. Many factors influence the decision of whether or not to remove a limb. In addition to disease severity, co-morbidities, and social and individual patient factors, many aspects of the structure of care services affect this decision, including access to primary care, quality of primary care, delays in referral, availability and quality of specialist resources, and prevailing medical opinion. It follows that a high incidence of amputation can reflect a higher disease prevalence, late referral, limited resources, or a particularly interventionist approach by a specialist team. Conversely, a low incidence of amputation can indicate a lower disease prevalence or severity, good management of diabetes in primary and secondary care, or a particularly conservative approach by an expert team. An inappropriately conservative approach could conceivably enhance suffering by condemning a person to months of incapacity before they die with an unhealed ulcer. The reported annual incidence of major amputation in industrialised countries ranges from 0.06 to 3.83 per 10(3) people at risk. Some centres have documented that the incidence is falling, but this is often from a baseline value that was unusually high. Other centres have reported that the incidence has not changed. The ultimate target is to achieve not only a decrease in incidence, but also a low overall incidence. This must be accompanied by improvements in morbidity, mortality, and patient function and mood.

International consensus and practical guidelines on the management and the prevention of the diabetic foot. International Working Group on the Diabetic Foot.

In 1999 the International Consensus on the Diabetic Foot was published by a group of independent experts. The consensus process is described in this article together with the Practical Guidelines which were part of the consensus document.

Diabetes-related lower-extremity amputations disproportionately affect Blacks and Mexican Americans.

BACKGROUND: We sought to identify the age-adjusted incidence of lower-extremity amputation (LEA) in Mexican Americans, blacks, and non-Hispanic whites with diabetes in south Texas. METHODS: We summarized medical records for hospitalizations for LEAs for 1993 in six metropolitan statistical areas in south Texas. RESULTS: Age-adjusted incidence per 10,000 patients with diabetes was 146.59 in blacks, 60.68 in non-Hispanic whites, and 94.08 in Mexican Americans. Of the patients, 47% of amputees had a history of amputation, and 17.7% were hospitalized more than once during 1993. Mexican Americans had more diabetes-related amputations (85.9%) than blacks (74.7%) or non-Hispanic whites (56.3%). CONCLUSIONS: This study is the first to identify the incidence of diabetes-related lower-extremity amputations in minorities using primary data. Minorities had both a higher incidence and proportion of diabetes-related, LEAs compared with non-Hispanic whites. Public health initiatives and national strategies, such as Healthy People 2000 and 2010, need to specifically focus on high-risk populations and high-risk geographic areas to decrease the frequency of amputation and reamputation.

Risk factors for above-knee amputations in diabetes mellitus.

BACKGROUND: Above-knee amputation (AKA) is a common complication in diabetics, mostly after one or more lower level amputations (LEAs) have been done. The aim of this study was to identify risk factors for AKAs among diabetics. METHODS: We abstracted 1,800 medical records of hospitalizations for LEA. Kaplan's comorbidity classification was used to rank disease severity. We used both univariate and multivariate models to identify risk factors for AKA. RESULTS: Of the 1,043 diabetic amputees in this study, 22% had AKA. Variables associated with AKA were locomotor impairment, severe anemia, history of lower extremity bypass surgery, body mass index (BMI) < 20 kg/m2, female sex, cerebrovascular disease, cardiovascular disease, and SGOT > 40 U/L. CONCLUSIONS: Most of these risk factors represent end-stage processes and do not have good treatment alternatives. Perhaps one of the practical applications of these data is not to describe risk of proximal amputations but instead to look more closely at candidates who should be considered for distal procedures.

Cost of diabetes-related amputations in minorities.

The objective of this study was to identify the direct cost and length of hospitalization of diabetes-related lower extremity amputations among Hispanics, African Americans, non-Hispanic whites, and Asians. The authors used a database from the office of Statewide Planning and Development in California that identified all hospitalizations for lower extremity amputations in the state in 1991. Amputation level was defined by the ICD-9-CM codes 84.11-84.18. The total hospital charges for diabetes-related lower extremity amputations for the state of California in 1991 was $141 million. The mean hospital charge (HC) per patient with all ethnic groups combined was $27,930; and the mean length of stay (LOS) was 15.9 days. African Americans had significantly higher mean charges ($32,383) and longer stays (17.3 days) compared to all other ethnic groups (p < .05). Toe-level amputations had lower HC (p < .05) and LOS (p < .01) than other amputation levels for all race groups. One-quarter of the population received multiple amputations during their hospital stay. These patients incurred significantly higher hospital charges ($44,731) and stayed in the hospital longer (23.4 days) than those receiving only a single amputation. There was a considerable variation in the HC and LOS among ethnic groups by level of amputation. The direct charges reported in this study suggest considerably higher overall direct costs than have been previously reported in the medical literature. The greater burden of disease experienced by African Americans is probably related to their higher amputation cost and longer hospitalization.

Institutionalization following diabetes-related lower extremity amputation.

PURPOSE: We are unaware of any report in the medical literature that has discussed risk factors for both mortality and discharge disposition following lower extremity amputation (LEA). Our aim was to report risk factors associated with in-hospital mortality and the need for institutional care in diabetics with LEAs. PATIENTS AND METHODS: We abstracted data for every hospitalization for a LEA from January 1 to December 31, 1993 in six metropolitan statistical areas in South Texas. Amputation level was categorized as foot, leg, or thigh. Discharge status categories were: home, nursing home, rehabilitation facility, and death. We used the Kaplan scale of cogent comorbidities to determine the relationship of 12 disease categories and their association with discharge status. RESULTS: There were 1,043 LEAs in South Texas in 1993. Although only 2.3% of the population was admitted from an institutional care facility, over 25% were discharged to one. Of the total population, 18.5% were discharged to a nursing home and 7.0% to a rehabilitation facility, and 5.1% died within the period of hospitalization. We performed a univariate analysis. Factors with a P <0.25 were included in a stepwise logistic regression analysis with an alpha of 0.05. High level (leg or thigh) amputation, peripheral vascular disease, male gender, and absence of advanced locomotor impairment were associated with discharge to a rehabilitation facility. For discharge to a nursing home, significant associations were found with: female gender, advanced age (>65 years), single marital status, high level amputation, and advanced cerebrovascular disease and locomotor impairment. Death following LEA was strongly associated with female gender, high level amputation, advanced renal disease, anemia, and congestive heart failure. CONCLUSION: A significant number of patients either die or require long-term care following a diabetes-related LEA, thus further adding to the burden of this sequela. Several clinical parameters are significantly associated with discharge status after this procedure. More prospective clinical research is needed to verify the associations and to clarify their application in practice.

Mortality following lower extremity amputation in minorities with diabetes mellitus.

The aim of this study was to identify the age adjusted and level specific mortality rate in African-Americans, Hispanics and non-Hispanic whites (NHW) during the perioperative period following a lower extremity amputation. We identified amputation data obtained from the Office of Statewide Planning and Development in California for 1991 from ICD-9-CM codes 84.11-84.18 and diabetes mellitus from any 250 related code. Amputations were categorized as foot (84.11-84.12), leg (84.13-84.16) or thigh (84.17-84.18). Death was coded under discharge status. Age adjusted and level specific mortality rates per 1000 amputees were calculated for each race/ethnic group. The age adjusted mortality was highest for African-Americans (41.39) compared to Hispanics (19.69) and NHW's (34.98). Mortality was consistently more frequent for proximal amputations. We conclude that mortality rates for persons with diabetes hospitalized for an amputation varied by race, gender and level of amputation. Higher prevalence or severity of risk factors may explain the excess mortality observed in African-Americans.

Amputation and reamputation of the diabetic foot.

The authors compare the level of foot amputation by age, prevalence of arterial disease as a precipitating factor, gender, and ethnicity in persons with diabetes mellitus. Medical records were abstracted for each hospitalization for a lower extremity amputation from January 1 to December 31, 1993, in six metropolitan statistical areas in south Texas. Amputation level was defined by ICD-9-CM codes and were categorized as foot, leg, and thigh amputations. Foot-level amputations were further subcategorized as hallux or first ray, middle, fifth, multiple digit or ray, and midfoot amputations. Only the highest amputation level for each individual was used in the analysis. Of 1,043 subjects undergoing a lower extremity amputation in south Texas in the year 1993, 477 received their amputation at the level of the foot. African-Americans requiring a foot-level amputation were at significantly higher risk to undergo a midfoot-level amputation than was the rest of the population. Nearly 40% of all subjects undergoing a foot-level amputation had a previous history of amputation. However, nearly 40% of subjects undergoing foot amputations had not been diagnosed either before or during admission with peripheral arterial occlusive disease, suggesting a causal pathway dependent primarily on neuropathy. This implies that better screening of diabetic patients with appropriate risk-directed treatment at the primary care level may significantly impact the large number of preventable diabetes-related lower extremity amputations.

Seasonal variations in lower extremity amputation.

The purpose of this study was to examine seasonal variations in nontraumatic amputation among diabetic and nondiabetic adults. We abstracted data from a database supplied by the state of New York for 14,555 amputations performed in 1990 and 1991. We categorized amputations into three different levels (foot, leg, and thigh). The most common season for a patient with diabetes to receive a lower-extremity amputation was spring (27.0%, p < 0.004; odds ratio 1.1, confidence interval 1.0 to 1.2), while winter was the most common in nondiabetic patients (27.3%, p < 0.005; odds ratio 1.1, confidence interval 1.0 to 1.2). When stratified by amputation level, fewer amputations at the level of the foot occurred during winter in patients with diabetes compared with those without diabetes (24.5% vs. 28.2%, p < 0.002; chi 2MM = 193.1, odds ratio = 1.2, confidence interval = 1.1 to 1.4). Fall was the least common season for amputation at nearly every level for both diabetic and nondiabetic groups, and more diabetic patients presented with an admission diagnosis of vascular disease (74.6% vs. 54.9%, p < 0.0001; chi 2MM = 612.3, odds ratio = 2.4, confidence interval = 2.3 to 2.6). In most diabetic patients, a primary etiologic factor for amputation is an infected neuropathic ulceration brought about or exacerbated by increased activity. By limiting activity, cold weather should act as a protective measure. The data in this study seem to support this notion.

The impact of gender on amputation.

The purpose of this report is to compare the proportion of lower extremity amputations among men and women with and without diabetes mellitus. We abstracted data from a database supplied by the State of New York for 14,555 nontraumatic amputations performed from 1990 through 1991, 58.8% of which were performed on patients with diabetes mellitus. We categorized amputations into three different levels (foot, leg, and thigh). Fifty-seven percent of the diabetes mellitus group were male, compared with 50% of the nondiabetic group. Men were younger than women regardless of the level of amputation in both the diabetic and nondiabetic population. Men with and without diabetes were significantly more likely to have a foot amputation, while diabetic and nondiabetic women were more likely to have a thigh amputation. When controlling for age, prevalence of vascular disease was not significantly different by gender in diabetic and nondiabetic groups at all amputation levels.

Methodological issues affect variability in reported incidence of lower extremity amputations due to diabetes.

The aim of this study is to evaluate the influence of different methodological techniques commonly utilized to identify the incidence of diabetes related lower extremity amputations. Medical records for each hospitalization for an amputation in 1993 in six metropolitan statistical areas in South Texas were abstracted. Every hospitalization, amputation and amputee was identified to allow separate analysis. Furthermore, data was categorized by ethnicity, level and age. Diabetes was verified using WHO criteria. Incidence rates were calculated per 10,000 diabetic patients at risk per year, both diagnosed only (DO) and diagnosed and undiagnosed combined (DUC). In total 1922 amputations were carried out during 1228 hospitalizations for 1043 amputees. The incidence rates per 10,000 diabetic patients (DO) were: 157.6 amputations, 101.2 hospitalizations and 87.0 amputees. When calculated using the DUC population at risk the rates were: 92.8 amputations, 59.6 hospitalizations and 51.2 amputees. Trends were found to be similar when analyzed by gender and ethnicity. The variability detected using of different methodological techniques to determine incidence rates is considerable and may have significant consequences when rates from different studies are compared.