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Objective: There is a dearth of long-term data regarding patient and limb survival in patients with diabetic foot ulcers (DFUs). The purpose of our study was therefore to prospectively investigate the limb and person survival of DFU patients during a follow-up period of more than 10 years.Research Design and Methods: Two hundred forty-seven patients with DFUs and without previous major amputation consecutively presenting to a single diabetes center between June 1998 and December 1999 were included in this study and followed up until May 2011. Mean patient age was 68.8 ± 10.9 years, 58.7% were male, and 55.5% had peripheral arterial disease (PAD). Times to first major amputation and to death were analyzed with Kaplan-Meier curves and Cox multiple regression.Results: A first major amputation occurred in 38 patients (15.4%) during follow-up. All but one of these patients had evidence of PAD at inclusion in the study, and 51.4% had severe PAD [ankle-brachial pressure index ≤0.4]). Age (hazard ratio [HR] per year, 1.05 [95% CI, 1.01-1.10]), being on dialysis (3.51 [1.02-12.07]), and PAD (35.34 [4.81-259.79]) were significant predictors for first major amputation. Cumulative mortalities at years 1, 3, 5, and 10 were 15.4, 33.1, 45.8, and 70.4%, respectively. Significant predictors for death were age (HR per year, 1.08 [95% CI, 1.06-1.10]), male sex ([1.18-2.32]), chronic renal insufficiency (1.83 [1.25-2.66]), dialysis (6.43 [3.14-13.16]), and PAD (1.44 [1.05-1.98]).Conclusions: Although long-term limb salvage in this modern series of diabetic foot patients is favorable, long-term survival remains poor, especially among patients with PAD or renal insufficiency. [ABSTRACT FROM AUTHOR]

This investigation was conducted to determine if a correlation exists between wound healing outcomes and serial debridement in chronic venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). We retrospectively analyzed the results from two controlled, prospective, randomized pivotal trials of topical wound treatments on 366 VLUs and 310 DFUs over 12 weeks. Weekly wound surface area changes following debridement and 12-week wound closure rates between centers and patients were evaluated. VLUs had a significantly higher median wound surface area reduction following clinical visits with surgical debridement as compared with clinical visits with no surgical debridement (34%, p=0.019). Centers where patients were debrided more frequently were associated with higher rates of wound closure in both clinical studies ( p=0.007 VLU, p=0.015 DFU). Debridement frequency per patient was not statistically correlated to higher rates of wound closure; however, there was some minor evidence of a positive benefit of serial debridement in DFUs (odds ratio-2.35, p=0.069). Our results suggest that frequent debridement of DFUs and VLUs may increase wound healing rates and rates of closure, though there is not enough evidence to definitively conclude a significant effect. Future clinical research in wound care should focus on the relationship between serial surgical wound debridement and improved wound healing outcomes as demonstrated in this study. [ABSTRACT FROM AUTHOR]

The use of antiseptics in wound care is often controversial and there is definitely a need for a non toxic, highly disinfective agent. This study assessed the efficacy of a neutral pH superoxidised aqueous solution (NpHSS) for infection control, odour reduction and surrounding skin and tissue damage on infected diabetic foot ulcerations. From November 2003 to March 2004, 45 patients with type 2 diabetes were randomised into a single-blind clinical trial comparing NpHSS (intervention group; n = 21) versus conventional disinfectant (control group; n = 16). All patients received comprehensive care including surgical debridement as appropriate, moist wound care, intensive glucose control and broad spectrum antibiotics. Treatment groups were matched in terms of sex, age (61.9 ± 11.9 versus 67.8 ± 11.6), years of diabetes duration (16.4 ± 8.1 versus 17 ± 10.2), obesity, HgAlc (7.1 ± 2 versus 6.7 ± 1.8), initial fasting glycaemia (163 ± 59 versus 152 ± 65.8 mg/dl), ulcer duration/week (13.7 ± 24 versus 15.1 ± 16.3), B/A Index (0.9 ± 0.5 versus 1.14 ± 0.7), depth and extent of infection/periwound cellulitis (groups B and C of the Tampico Hospital Classification) as well as aetiology ( P = 0·647). Odour reduction was achieved in all NpHSS patients (100% versus 25%; P < 0·01) and surrounding cellulitis diminished ( P < 0.001) in 17 patients (80.9% versus 43.7%). Nineteen patients in the NpHSS group showed advancement to granulating tissue stage (90.4% versus 62.5%; P = 0.05) with significantly less tissue toxicity (94% versus 31.2%; P < 0.01). A non toxic, NpHSS, as part of a comprehensive care regimen, may be more efficacious in infection control, odour and erythema reduction than conventional disinfectants in treatment of diabetic foot infections. [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]

Background: Various methods of cast immobilization have been recommended for the treatment of distal forearm fractures in children. The purpose of this study was to determine if short arm casts are as effective as long arm casts in the treatment of displaced fractures of the distal third of the forearm in these patients.Methods: In a prospective randomized trial, consecutive patients, four years of age or older, who presented to The Women's and Children's Hospital of Buffalo with a displaced fracture of the distal third of the forearm were randomized to treatment with a short or long arm plaster cast. Radiographs were analyzed for displacement, angulation, and deviation at the time of injury, after reduction, and at subsequent follow-up intervals. The cast index at the fracture level, used to assess the quality of the cast molding, was determined from the postreduction radiographs. Changes between postreduction and final values for displacement, angulation, and deviation; the ranges of motion of both wrists and elbows; the need for physical therapy; and responses to a questionnaire used to evaluate the effects of the cast on activities of daily living were compared between the groups.Results: One hundred and thirteen of the 151 patients who were assessed for eligibility were analyzed. The follow-up rate was 92%, and the average duration of follow-up was eight months. Sixty long arm casts and fifty-three short arm casts were used. There were no significant differences between the two groups with regard to patient demographics, initial fracture characteristics, mechanism of injury, cast index, or the change in displacement, angulation, or deviation during treatment. The fractures that lost reduction in the cast had significantly higher cast indices, indicating poor cast-molding. A comparison of partially and completely displaced fractures revealed no difference between the groups with regard to the change between the postreduction and final amount of displacement. Patients treated with a short arm cast missed fewer school days and were less likely to require assistance with various activities of daily living.Conclusions: A well-molded short arm cast can be used as effectively as a long arm cast to treat fractures of the distal third of the forearm in children four years of age and older, and they interfere less with daily activities. [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: We have previously demonstrated that high plantar pressures can predict foot ulceration in diabetic patients. The aim of the present study was to evaluate both the relationship between forefoot and rearfoot plantar pressure in diabetic patients with different degrees of peripheral neuropathy and their role in ulcer development.Research Design and Methods: Diabetic patients of a 30-month prospective study were classified according to the neuropathy disability score: scores of 0, 1-5, 6-16, and 17-28 are defined as absent (n = 20), mild (n = 66), moderate (n = 95), and severe (n = 57) neuropathy, respectively. The F-Scan mat system was used to measure dynamic plantar pressures. The peak pressures under the forefoot and the rearfoot were selectively measured for each foot, and the forefoot-to-rearfoot ratio (F/R ratio) was calculated.Results: Foot ulcers developed in 73 (19%) feet. The peak pressures were increased in the forefoot of the severe and moderate neuropathic groups compared with the mild neuropathic and non-neuropathic groups (6.2 +/- 4.5 and 3.8 +/- 2.7 vs. 3.0 +/- 2.1 and 3.3 +/- 2.1 kg/cm(2) [mean +/- SD], respectively; P < 0.0001). The rearfoot pressures were also higher in the severe and moderate neuropathic groups compared with the mild neuropathic and non-neuropathic groups (3.2 +/- 2.0 and 3.2 +/- 1.9 vs. 2.5 +/- 1.3 and 2.3 +/- 1.0, respectively; P < 0.0001). The F/R ratio was increased only in the severe group compared with the moderate and mild neuropathic and non-neuropathic groups (2.3 +/- 2.4 vs. 1.5 +/- 1.2, 1.3 +/- 0.9, and 1.6 +/- 1.0, respectively; P < 0.0001). In a logistic regression analysis, both forefoot pressure (odds ratio 1.19 [95% CI 1.11-1.28], P < 0.0001) and the F/R ratio (1.37 [1.16-1.61], P < 0.0001) were related to risk of foot ulceration, whereas rearfoot pressure was not.Conclusions: Both the rearfoot and forefoot pressures are increased in the diabetic neuropathic foot, whereas the F/R ratio is increased only in severe diabetic neuropathy, indicating an imbalance in pressure distribution with increasing degrees of neuropathy. This may lend further evidence toward the concept that equinus develops in the latest stages of peripheral neuropathy and may play an important role in the etiology of diabetic foot ulceration. [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: We assessed in a randomized prospective trial the effectiveness of Graftskin, a living skin equivalent, in treating noninfected nonischemic chronic plantar diabetic foot ulcers.Research Design and Methods: In 24 centers in the U.S., 208 patients were randomly assigned to ulcer treatment either with Graftskin (112 patients) or saline-moistened gauze (96 patients, control group). Standard state-of-the-art adjunctive therapy, which included extensive surgical debridement and adequate foot off-loading, was provided in both groups. Graftskin was applied at the beginning of the study and weekly thereafter for a maximum of 4 weeks (maximum of five applications) or earlier if complete healing occurred. The major outcome of complete wound healing was assessed by intention to treat at the 12-week follow-up visit.Results: At the 12-week follow-up visit, 63 (56%) Graftskin-treated patients achieved complete wound healing compared with 36 (38%) in the control group (P = 0.0042). The Kaplan-Meier median time to complete closure was 65 days for Graftskin, significantly lower than the 90 days observed in the control group (P = 0.0026). The odds ratio for complete healing for a Graftskin-treated ulcer compared with a control-treated ulcer was 2.14 (95% CI 1.23-3.74). The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis and lower-limb amputations, both of which were less frequent in the Graftskin group.Conclusions: Application of Graftskin for a maximum of 4 weeks results in a higher healing rate when compared with state-of-the-art currently available treatment and is not associated with any significant side effects. Graftskin may be a very useful adjunct for the management of diabetic foot ulcers that are resistant to the currently available standard of care. [ABSTRACT FROM AUTHOR]

Objective: Diabetic foot ulceration is a preventable long-term complication of diabetes. A multicenter prospective follow-up study was conducted to determine which risk factors in foot screening have a high association with the development of foot ulceration.Research Design and Methods: A total of 248 patients from 3 large diabetic foot centers were enrolled in a prospective study. Neuropathy symptom score, neuropathy disability score (NDS), vibration perception threshold (VPT), Semmes-Weinstein monofilaments (SWFs), joint mobility, peak plantar foot pressures, and vascular status were evaluated in all patients at the beginning of the study. Patients were followed-up every 6 months for a mean period of 30 months (range 6-40), and all new foot ulcers were recorded. The sensitivity, specificity, and positive predictive value of each risk factor were evaluated.Results: Foot ulcers developed in 95 feet (19%) or 73 patients (29%) during the study. Patients who developed foot ulcers were more frequently men, had diabetes for a longer duration, had nonpalpable pedal pulses, had reduced joint mobility, had a high NDS, had a high VPT, and had an inability to feel a 5.07 SWE NDS alone had the best sensitivity, whereas the combination of the NDS and the inability to feel a 5.07 SWF reached a sensitivity of 99%. On the other hand, the best specificity for a single factor was offered by foot pressures, and the best combination was that of NDS and foot pressures. Univariate logistical regression analysis yielded a statistically significant odds ratio (OR) for sex, race, duration of diabetes, palpable pulses, history of foot ulceration, high NDSs, high VPTs, high SWFs, and high foot pressures. In addition, 94 (99%) of the 95 ulcerated feet had a high NDS and/or SWF which resulted in the highest OR of 26.2 (95% CI 3.6-190). Furthermore, in multivariate logistical regression analysis, the only significant factors were high NDSs, VPTs, SWFs, and foot pressures.Conclusions: Clinical examination and a 5.07 SWF test are the two most sensitive tests in identifying patients at risk for foot ulceration, especially when the tests are used in conjunction with each other. VPT measurements are also helpful and can be used as an alternative. Finally, foot pressure measurements offer a substantially higher specificity and can be used as a postscreening test in conjunction with providing appropriate footwear. [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]

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]

Objective: Pressure mitigation is crucial for the healing of plantar diabetic foot ulcers. We therefore discuss characteristics and considerations associated with the use of offloading devices.Research Design and Methods: A diabetic foot ulcer management survey was sent to foot clinics in all 50 states and the District of Columbia in 2005. A total of 901 geographically diverse centers responded. The survey recorded information regarding usage frequency and characteristics of assessment and treatment of diabetic foot ulcers in each center.Results: Of the 895 respondents who treat diabetic foot ulcers, shoe modifications (41.2%, P < 0.03) were the most common form of pressure mitigation, whereas total contact casts were used by only 1.7% of the centers.Conclusions: This study reports the usage and characteristics of offloading devices in the care of diabetic foot ulcers in a broadly distributed geographic sample. Less than 2% of specialists use what has been termed the "gold standard" (total contact cast) for treating the majority of diabetic foot ulcers. [ABSTRACT FROM AUTHOR]

This retrospective analysis included 36 patients who presented with late-onset tibia vara during a 15-year period. Mean patient age at presentation was 12.8 years. Seventy-eight percent of patients were male, 78% were black, and 72% presented with unilateral deformity. Mean initial varus was 21 degrees with 5.8 degrees at the femur and 12.3 degrees at the tibia. Surgical correction was performed in 31 patients; 5 patients refused surgery. Patients who had osteotomies had a higher rate of complications than those treated with stapling. Epiphyseal stapling has unpredictable results in patients with late-onset tibia vara and is only a temporizing procedure in approximately half of cases. None of the treatments resulted in optimal knee function or alignment, and the long-term prognosis for late-onset tibia vara is guarded at best. [ABSTRACT FROM AUTHOR]