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OBJECTIVE: To evaluate the accuracy and effective service life of commercially available Semmes-Weinstein monofilaments with repetitive loading. METHODS: We obtained 6 brands of Semmes-Weinstein monofilaments (SWM) from commercial vendors identified from the Internet and the federal registry. Five monofilaments of each brand were subjected to repeat loading cycles, allowed to rest over night and loaded again the next day. First, sets of five monofilaments were loaded 25 times for each of five days. Then sets of five monofilaments were subjected to 200 loading cycles a day for 15 days. A testing jig ensured each SWM was loaded perpendicular to a digital pressure plate. The buckling force was measured via the pressure plate to determine failure loads. Several statistical techniques were used to examine the behavior of the monofilaments over repeated loadings: time series analysis, ANOVA and nonparametric comparisons of load distributions. RESULTS: The monofilaments tested were neither precise nor accurate. The plasticity of filaments increased with repeated loadings resulting in lower bending forces. Individual and average bending forces varied widely both within and between monofilament brands. All monofilaments showed a typical material failure pattern. Initially the bending force was high but rapidly decreased and then leveled out at levels 1-2g lower than the starting values. After resting over night, the initial bending force was again high but usually not as high as the previous day and bending forces decreased and then leveled out. Most monofilaments did not start at the accepted 10-g buckling force but varied by up to 30% (p<0.01). At best, monofilaments starting at the accepted 10±1g buckling force would remain within a usable range (9-11g) for 7-9 days or to evaluate 70-90 patients. CONCLUSION: Commercially available SWM have significant variability within and between devices from different manufacturers. Their actual bending force varies widely from their designated 10g value. When used they have a short service life where the instrument is within 10% of their initial bending force which is not usually the stated 10g of force. [ABSTRACT FROM AUTHOR]

Background: As a result of the impact of health disparities on the healthcare system such as their influence on arenas significant to healthcare distribution, including cost, quality, and access, identification and resolution of health disparities is a primary national agenda item. Resolution of disparities in amputation is an area of opportunity that warrants further consideration.Questions/purposes: The purposes of our review are to highlight current data on disparities in amputation in minorities and to consider future goals related to an elimination of this disparity.Methods: Studies on disparities in amputation were accessed using the following databases: PubMed, Cinahl, OVID/Medline, Embase, and Cochrane databases. In each database, a search of title/abstract was performed for the search terms "disparities and amputation," "race and amputation," and "diabetes and amputation." Each search was limited by human and English language. Where are we now? A disparity exists in both frequency and level of amputation in minorities both in the presence and absence of a diagnosis of diabetes. Where do we need to go? A need exists for future research involving a more deliberate examination of the use of preventive screening for patients at high risk for amputation across medical settings. How do we get there? Research in this area would benefit from funding, large-scale data collection, and physician exposure to education on high-risk patients and preventive screening opportunities. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The purpose of this study was to determine the efficacy of anodyne monochromatic infrared photo energy (MIRE) in-home treatments over a 90-day period to improve peripheral sensation and self-reported quality of life in individuals with diabetes. RESEARCH DESIGN AND METHODS: This was a double-blind, randomized, sham-controlled clinical trail. We randomly assigned 69 individuals with diabetes and a vibration perception threshold (VPT) between 20 and 45 V to two treatment groups: active or sham treatment. Sixty patients (120 limbs) completed the study. Anodyne units were used at home every day for 40 min for 90 days. We evaluated nerve conduction velocities, VPT, Semmes-Weinstein monofilaments (SWM) (4-, 10-, 26-, and 60-g monofilaments), the Michigan Neuropathy Screening Instrument (MNSI), a 10-cm visual analog pain scale, and a neuropathy-specific quality of life instrument. We used a nested repeated-measures multiple ANOVA design. Two sites (great toe and fifth metatarsal) were tested on both the left and right feet of each patient, so two feet were nested within each patient and two sites were nested within each foot. To analyze the ordinal SWM scores, we used a nonparametric factorial analysis for longitudinal data. RESULTS: There were no significant differences in measures for quality of life, MNSI, VPT, SWM, or nerve conduction velocities in active or sham treatment groups (P > 0.05). CONCLUSIONS: Anodyne MIRE therapy was no more effective than sham therapy in the treatment of sensory neuropathy in individuals with diabetes. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We sought to assess the accuracy of the probe-to-bone (PTB) test in diagnosing foot osteomyelitis in a cohort of diabetic patients with bone culture proven disease. RESEARCH DESIGN AND METHODS: In this 2-year longitudinal cohort study, we enrolled 1,666 consecutive diabetic individuals who underwent an initial standardized detailed foot assessment, followed by examinations at regular intervals. Patients were instructed to immediately come to the foot clinic if they developed a lower-extremity complication. For all patients with a lower-extremity wound, we compared the results of the PTB test with those of a culture of the affected bone. We called PTB positive if the bone or joint was palpable and defined osteomyelitis as a positive bone culture. RESULTS: Over a mean of 27.2 months of follow-up, 247 patients developed a foot wound and 151 developed 199 foot infections. Osteomyelitis was found in 30 patients: 12% of those with a foot wound and 20% in those with a foot infection. When all wounds were considered, the PTB test was highly sensitive (0.87) and specific (0.91); the positive predictive value was only 0.57, but the negative predictive value was 0.98. CONCLUSIONS: The PTB test, when used in a population of diabetic patients with a foot wound among whom the prevalence of osteomyelitis was 12%, had a relatively low positive predictive value, but a negative test may exclude the diagnosis. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a temperature monitoring instrument to reduce the incidence of foot ulcers in individuals with diabetes who have a high risk for lower extremity complications. RESEARCH DESIGN AND METHODS: In this physician-blinded, randomized, 15-month, multicenter trial, 173 subjects with a previous history of diabetic foot ulceration were assigned to standard therapy, structured foot examination, or enhanced therapy groups. Each group received therapeutic footwear, diabetic foot education, and regular foot care. Subjects in the structured foot examination group performed a structured foot inspection daily and recorded their findings in a logbook. If standard therapy or structured foot examinations identified any foot abnormalities, subjects were instructed to contact the study nurse immediately. Subjects in the enhanced therapy group used an infrared skin thermometer to measure temperatures on six foot sites each day. Temperature differences >4 degrees F (>2.2 degrees C) between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperatures normalized. RESULTS: The enhanced therapy group had fewer foot ulcers than the standard therapy and structured foot examination groups (enhanced therapy 8.5 vs. standard therapy 29.3%, P = 0.0046 and enhanced therapy vs. structured foot examination 30.4%, P = 0.0029). Patients in the standard therapy and structured foot examination groups were 4.37 and 4.71 times more likely to develop ulcers than patients in the enhanced therapy group. CONCLUSIONS: Infrared temperature home monitoring, in serving as an 'early warning sign,' appears to be a simple and useful adjunct in the prevention of diabetic foot ulcerations. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to evaluate the effectiveness of a removable cast walker (RCW) and an "instant" total contact cast (iTCC) in healing neuropathic diabetic foot ulcerations.Research Design and Methods: We randomly assigned 50 patients with University of Texas grade 1A diabetic foot ulcerations into one of two off-loading treatment groups: an RCW or the same RCW wrapped with a cohesive bandage (iTCC) so patients could not easily remove the device. Subjects were evaluated weekly for 12 weeks or until wound healing.Results: An intent-to-treat analysis showed that a higher proportion of patients had ulcers that were healed at 12 weeks in the iTCC group than in the RCW group (82.6 vs. 51.9%, P = 0.02, odds ratio 1.8 [95% CI 1.1-2.9]). Of the patients with ulcers that healed, those treated with an iTCC healed significantly sooner (41.6 +/- 18.7 vs. 58.0 +/- 15.2 days, P = 0.02).Conclusions: Modification of a standard RCW to increase patient adherence to pressure off-loading may increase both the proportion of ulcers that heal and the rate of healing of diabetic neuropathic wounds. [ABSTRACT FROM AUTHOR]

Over the past generation, there have been a number of significant advances in wound healing in general. Unfortunately, much of this has not translated into increased success in healing wounds on the sole of the foot. We believe that much of this therapeutic disconnect has to do with an inadequate merging of pressure off-loading technologies and active wound-healing technologies. This article discusses such a merger between removable cast walkers and topical negative pressure (also known as vacuum-assisted closure). [ABSTRACT FROM AUTHOR]

Objective: To report the incidence of diabetes-related lower-extremity complications in a cohort of patients enrolled in a diabetes disease management program.Research Design and Methods: We evaluated screening results and clinical outcomes for the first 1,666 patients enrolled in a disease management program for a period of 24 months (50.3% men, aged 69.1 +/- 11.1 years).Results: The incidence of ulceration, infection, amputation, and lower-extremity bypass was 68.4, 36.5, 5.9, and 7.7 per 1,000 persons with diabetes per year. Amputation incidence was higher in Mexican Americans than in non-Hispanic whites (7.4/1,000 vs. 4.1/1,000; P = 0.003, odds ratio [OR] 1.8, 95% CI 1.2-2.7). The amputation-to-ulcer ratio was 8.7%. The incidence of Charcot arthropathy was 8.5/1,000 per year. Charcot was more common in non-Hispanic whites than in Mexican Americans (11.7/1,000 vs. 6.4/1,000; P = 0.0001, 1.8, 1.3-2.5). The prevalence of peripheral vascular disease was 13.5%, with no significant difference based on ethnicity (P = 0.3). There was not a significant difference in incidence of foot infection (P = 0.9), lower-extremity bypass (P = 0.3), or ulceration (P = 0.1) based on ethnicity. However, there were more failed bypasses in Mexican Americans (33%) than in non-Hispanic whites (7.1%). Mexican Americans were 3.8 times more likely to have a failed bypass (leading to an amputation) or be diagnosed as "nonbypassable" than non-Hispanic whites (75.0 vs. 44.0%; P = 0.01, 3.8, 1.2-11.8).Conclusions: The incidence of amputation is higher in Mexican Americans, despite rates of ulceration, infection, vascular disease, and lower-extremity bypass similar to those of non-Hispanic whites. There may be factors associated with failed or failure to bypass that mandate further investigation. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of total-contact casts (TCCs), removable cast walkers (RCWs), and half-shoes to heal neuropathic foot ulcerations in individuals with diabetes.Research Design and Methods: In this prospective clinical trial, 63 patients with superficial noninfected, nonischemic diabetic plantar foot ulcers were randomized to one of three off-loading modalities: TCC, half-shoe, or RCW. Outcomes were assessed at wound healing or at 12 weeks, whichever came first. Primary outcome measures included proportion of complete wound healing at 12 weeks and activity (defined as steps per day).Results: The proportions of healing for patients treated with TCC, RCW, and half-shoe were 89.5, 65.0, and 58.3%, respectively. A significantly higher proportion of patients were healed by 12 weeks in the TCC group when compared with the two other modalities (89.5 vs. 61.4%, P = 0.026, odds ratio 5.4, 95% CI 1.1-26.1). There was also a significant difference in survival distribution (time to healing) between patients treated with a TCC and both an RCW (P = 0.033) and half-shoe (P = 0.012). Patients were significantly less active in the TCC (600.1 +/- 320.0 daily steps) compared with the half-shoe (1,461.8 +/- 1,452.3 daily steps, P = 0.04). There was no significant difference in the average number of steps between the TCC and the RCW (767.6 +/- 563.3 daily steps, P = 0.67) or the RCW and the half-shoe (P = 0.15).Conclusions: The TCC seems to heal a higher proportion of wounds in a shorter amount of time than two other widely used off-loading modalities, the RCW and the half-shoe. [ABSTRACT FROM AUTHOR]

Objective: To document peer-reviewed medical publications that have reported on hyperbaric oxygen (HBO) therapy as an adjunct to standard lower-extremity wound care, focusing on publications dealing with the diabetic foot.Research Design and Methods: A review of the medical literature was conducted using MEDLINE. Research articles involving HBO treatment and the diabetic foot were critiqued to identify factors that may have been a source of bias.Results: Of the published reports on human studies, seven involved diabetes-related foot pathology. Five of these studies, two of which were randomized, included a control group that did not receive HBO therapy The controlled diabetic foot studies included an average of 28 subjects in the HBO therapy group (range 10-62) and an average of 16.2 subjects in the non-HBO control group (range 5-33). Most of the published reports have several potential sources of bias, including, but not limited to, inadequate evaluation of comorbid conditions relevant to wound healing, small sample size, and poor documentation of wound size or severity. Four of the seven reports involving the diabetic foot were published by a group of researchers at the University of Milan between 1987 and 1996.Conclusions: Additional randomized placebo-controlled clinical trials in large diabetic populations would further lend credence to the presumption that HBO therapy improves clinical outcomes. Given the relatively high cost of this treatment modality, perhaps a more acute awareness of the medical literature would reduce the economic burden that HBO therapy imposes on care providers that are financially at risk. [ABSTRACT FROM AUTHOR]

Background and Purpose. The purpose of this study was to compare skin temperatures in patients with asymptomatic peripheral sensory neuropathy, patients with neuropathic ulcers, and patients with Charcot's arthropathy using the contralateral limb as a control. Subjects. On a retrospective basis, patients with diabetes (N=143) were divided into three groups: patients with asymptomatic sensory neuropathy (n=78), patients with neuropathic foot ulcers (n=44), and patients with neuropathic fractures (Charcot's arthropathy) (n=21). Methods. We evaluated the subjects' skin temperatures with a portable hand-held infrared skin temperature probe at the time pathology was initially identified and at subsequent clinical visits for an average of 22.1 months (SD=6.4). Skin temperatures of the contralateral foot were measured as a control. Results. There were differences in skin temperature between the affected foot and the contralateral (ie, nonaffected) foot among the patients with Charcot's arthropathy (8.3 degrees F) and the patients with neuropathic ulcers (5.6 degrees F), with no difference identified among the patients with asymptomatic sensory neuropathy. Five patients with neuropathic ulcers experienced reulceration a mean of 12.2 months (SD=6.4) after initial healing, with a corresponding increase in skin temperature (89.6 degrees +/- 1.2 degrees F versus 82.5 degrees +/= 2.9 degrees F) at the clinic visit immediately preceding reinjury. Conclusion and Discussion. The data suggest that monitoring of the corresponding contralateral foot site may provide clinical information before other clinical signs of injury can be identified. [ABSTRACT FROM AUTHOR]

Diabetic ulcers are the most common foot injuries leading to lower extremity amputation. Family physicians have a pivotal role in the prevention or early diagnosis of diabetic foot complications. Management of the diabetic foot requires a thorough knowledge of the major risk factors for amputation, frequent routine evaluation and meticulous preventive maintenance. The most common risk factors for ulcer formation include diabetic neuropathy, structural foot deformity and peripheral arterial occlusive disease. A careful physical examination, buttressed by monofilament testing for neuropathy and noninvasive testing for arterial insufficiency, can identify patients at risk for foot ulcers and appropriately classify patients who already have ulcers or other diabetic foot complications. Patient education regarding foot hygiene, nail care and proper footwear is crucial to reducing the risk of an injury that can lead to ulcer formation. Adherence to a systematic regimen of diagnosis and classification can improve communication between family physicians and diabetes subspecialists and facilitate appropriate treatment of complications. This team approach may ultimately lead to a reduction in lower extremity amputations related to diabetes. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the frequency of foot prevention strategies among high-risk patients with diabetes.Research Design and Methods: Electronic medical records were used to identify 150 patients on dialysis and 150 patients with previous foot ulceration or amputation with 30 months follow-up to determine the frequency with which patients received education, podiatry care, and therapeutic shoes and insoles as prevention services.Results: Few patients had formal education (1.3%), therapeutic shoes/insoles (7%), or preventative podiatric care (30%). The ulcer incidence density was the same in both groups (210 per 1,000 person-years). In contrast, the amputation incidence density was higher in the dialysis group compared with the ulcer group (58.7 vs. 13.1 per 1,000 person-years, P < 0.001). Patients on dialysis were younger and more likely to be of non-Hispanic white descent (P = 0.006) than patients with a previous history of ulcer or amputation.Conclusions: Prevention services are infrequently provided to high-risk patients. [ABSTRACT FROM AUTHOR]

The prevalence of diabetes mellitus is growing at epidemic proportions in the United States and worldwide. Most alarming is the steady increase in type 2 diabetes, especially among young and obese people. An estimated 7% of the US population has diabetes, and because of the increased longevity of this population, diabetes-associated complications are expected to rise in prevalence.Foot ulcerations, infections, Charcot neuroarthropathy, and peripheral arterial disease frequently result in gangrene and lower limb amputation. Consequently, foot disorders are leading causes of hospitalization for persons with diabetes and account for billion-dollar expenditures annually in the US. Although not all foot complications can be prevented, dramatic reductions in frequency have been achieved by taking a multidisciplinary approach to patient management. Using this concept, the authors present a clinical practice guideline for diabetic foot disorders based on currently available evidence, committee consensus, and current clinical practice. The pathophysiology and treatment of diabetic foot ulcers, infections, and the diabetic Charcot foot are reviewed. While these guide-lines cannot and should not dictate the care of all affected patients, they provide evidence-based guidance for general patterns of practice. If these concepts are embraced and incorporated into patient management protocols, a major reduction in diabetic limb amputations is certainly an attainable goal. [ABSTRACT FROM AUTHOR]