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OBJECTIVE: Chronic diabetic foot ulcers are a source of major concern for both patients and health care systems. The aim of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT) in the management of chronic diabetic foot ulcers. RESEARCH DESIGN AND METHODS: The Hyperbaric Oxygen Therapy in Diabetics with Chronic Foot Ulcers (HODFU) study was a randomized, single-center, double-blinded, placebo-controlled clinical trial. The outcomes for the group receiving HBOT were compared with those of the group receiving treatment with hyperbaric air. Treatments were given in a multi-place hyperbaric chamber for 85-min daily (session duration 95 min), five days a week for eight weeks (40 treatment sessions). The study was performed in an ambulatory setting. RESULTS: Ninety-four patients with Wagner grade 2, 3, or 4 ulcers, which had been present for >3 months, were studied. In the intention-to-treat analysis, complete healing of the index ulcer was achieved in 37 patients at 1-year of follow-up: 25/48 (52%) in the HBOT group and 12/42 (29%) in the placebo group (P = 0.03). In a sub-analysis of those patients completing >35 HBOT sessions, healing of the index ulcer occurred in 23/38 (61%) in the HBOT group and 10/37 (27%) in the placebo group (P = 0.009). The frequency of adverse events was low. CONCLUSIONS: The HODFU study showed that adjunctive treatment with HBOT facilitates healing of chronic foot ulcers in selected patients with diabetes.

OBJECTIVE:--This study was designed to test the safety, effectiveness, and costs of off-loading with a novel, off-the-shelf irremovable device in the management of diabetic foot ulceration (DFU). RESEARCH DESIGN AND METHODS--We prospectively evaluated off-loading of neuropathic plantar ulcers in 40 diabetic outpatients attending our diabetic foot clinic and compared healing rates at the 12-week follow-up, number and severity of adverse events, healing time, costs and applicability of the device, and patients' satisfaction between those randomly assigned to total contact casting (TCC; group A) or to the Optima Diab walker (group B). Deep or infected ulcers were excluded. RESULTS:--No difference between groups A and B was observed in healing rates at 12 weeks (95 vs. 85%), healing time (6.5 ± 4.4 vs. 6.7 ± 3.4 weeks), and number of adverse events (six versus four). Treatment was significantly less expensive in group B, which showed a mean reduction of costs of 78% compared with group A (P < 0.001). Practicability was more favorable in group B, with a reduction of 77 and 58% of the time required for application and removal of the devices, respectively (P < 0.001). Patients' satisfaction with the treatment was higher in group B (P < 0.01). CONCLUSIONS:--The Optima Diab walker is as safe and effective as TCC in the management of DFU, but its lower costs and better applicability may be of help in spreading the practice of off-loading among the centers that manage the diabetic foot.

Background In 2007, we reported a summary of data comparing diabetic foot complications to cancer. The purpose of this brief report was to refresh this with the best available data as they currently exist. Since that time, more reports have emerged both on cancer mortality and mortality associated with diabetic foot ulcer (DFU), Charcot arthropathy, and diabetes-associated lower extremity amputation. Methods We collected data reporting 5-year mortality from studies published following 2007 and calculated a pooled mean. We evaluated data from DFU, Charcot arthropathy and lower extremity amputation. We dichotomized high and low amputation as proximal and distal to the ankle, respectively. This was compared with cancer mortality as reported by the American Cancer Society and the National Cancer Institute. Results Five year mortality for Charcot, DFU, minor and major amputations were 29.0, 30.5, 46.2 and 56.6%, respectively. This is compared to 9.0% for breast cancer and 80.0% for lung cancer. 5 year pooled mortality for all reported cancer was 31.0%. Direct costs of care for diabetes in general was $237 billion in 2017. This is compared to $80 billion for cancer in 2015. As up to one-third of the direct costs of care for diabetes may be attributed to the lower extremity, these are also readily comparable. Conclusion Diabetic lower extremity complications remain enormously burdensome. Most notably, DFU and LEA appear to be more than just a marker of poor health. They are independent risk factors associated with premature death. While advances continue to improve outcomes of care for people with DFU and amputation, efforts should be directed at primary prevention as well as those for patients in diabetic foot ulcer remission to maximize ulcer-free, hospital-free and activity-rich days.

To evaluate the magnitude and impact of diabetic foot ulcers (DFUs) in emergency department (ED) settings from 2006-2010 in the United States (US). This cross-sectional study utilized Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) National Emergency Department Sample (NEDS) discharge records of ED cases among persons ≥18 years with any-listed diagnosis of DFUs. Multivariable analyses were conducted for clinical outcomes of patient disposition from the ED and economic outcomes of charges and lengths of stay based upon patient demographic and socioeconomic factors, hospital characteristics, and comorbid disease states. Overall, 1,019,861 cases of diabetic foot complications presented to EDs in the US from 2006-2010, comprising 1.9% of the 54.2 million total diabetes cases. The mean patient age was 62.5 years and 59.4% were men. The national bill was $1.9 billion per year in the ED and $8.78 billion per year (US$ 2014) including inpatient charges among the 81.2% of cases that were admitted. Clinical outcomes included mortality in 2.0%, sepsis in 9.6% of cases and amputation in 10.5% (major-minor amputation ratio of 0.46). Multivariable analyses found that those residing in non-urban locations were associated with +51.3%, +14.9%, and +41.4% higher odds of major amputation, minor amputation, and inpatient death, respectively (p<0.05). Medicaid beneficiaries incurred +21.1% and +25.1% higher odds for major or minor amputations, respectively, than Medicare patients (p<0.05). Persons within the lowest income quartile regions were associated with a +38.5% higher odds of major amputation (p<0.05) versus the highest income regions. Diabetic foot complications exact a substantial clinical and economic toll in acute care settings, particularly among the rural and working poor. Clear opportunities exist to reduce costs and improve outcomes for this systematically-neglected condition by establishing effective practice paradigms for screening, prevention, and coordinated care.

Diabetic foot ulcer (DFU) is a common cause of admission in patients with diabetes. Diabetes increases the likelihood of inpatient Major Adverse Cardiovascular Events (MACE), and the presence of polyvascular disease (PD), defined by the presence of atherosclerosis in two or more arterial beds, further amplifies this risk. We assessed the impact of PD on outcomes in patients admitted due to a DFU. In this retrospective single-center study, we enrolled adult patients admitted to the diabetic foot unit between 2014 and 2019. The primary outcome was a composite of inpatient MACE or death. Secondary outcomes included amputations, leg revascularization, duration of admission and 1-year mortality. We additionally collected survival data till the end of 2023. A total of 537 patients were enrolled in the study, 264 suffering of PD. The primary endpoint occurred in 12.5 % and 4.4 % of patients with vs. without PD (p = 0.001). Patients with PD had an increased incidence of vascular interventions (42 % vs. 19.4 %, p < 0.001), any amputation (67.4 % vs. 48.4 %, p < 0.001) and major amputation (35.6 % vs. 13.2 %, p < 0.001). They had longer admissions (median 19 vs. 17 days, p = 0.002) and higher 1-year mortality rates (33.0 % vs. 12.1 %, p < 0.001). During 10-year follow up (median 3.3 years) median survival was 2.0 vs. 5.9 years for patients with vs. without PD (p < 0.001). PD in patients admitted with a DFU is associated with poor inpatient and long-term outcomes. This highlights the need for comprehensive risk assessment, optimization of in-patient management and long-term control of cardiovascular risk factors. •Nearly half of the patients admitted due to an acute diabetic foot ulcer suffer of polyvascular disease (PD).•Patients with PD have poor outcomes - higher risk of inpatient major adverse cardiovascular event, amputation or death.•Long-term survival of PD patients is markedly low with median survival of 2.0 years vs. 5.9 years in patients with no PD.•Guideline directed medical therapy should be offered to these patients aiming to improve these grim outcomes.

Studies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore, to assess the efficacy of HBOT on diabetic foot ulcer among diabetic patients, controlled clinical trials were searched through PubMed, EMBASE, Clinical key, Ovid Discovery, ERMED, Clinical Trials.gov databases for randomized controlled trials (RCTs) and other sources until 15 September 2020. Studies that evaluated the effect of HBOT on diabetic foot ulcer, complete healing, amputation, adverse events, ulcer reduction area, and mortality rate were included. Of 1984 study records screened, 14 studies (768 participants) including twelve RCTs, and two CCTs were included as per inclusion criteria. The results with pooled analysis have shown that HBOT was significantly effective in complete healing of diabetic foot ulcer (OR = 0.29; 95% CI 0.14–0.61; I 2  = 62%) and reduction of major amputation (RR = 0.60; 95% CI 0.39–0.92; I 2  = 24%). Although, it was not effective for minor amputations (RR = 0.82; 95% CI 0.34–1.97; I 2  = 79%); however, less adverse events were reported in standard treatment group (RR = 1.68; 95% CI 1.07–2.65; I 2  = 0%). Nevertheless, reduction in mean percentage of ulcer area and mortality rate did not differ in HBOT and control groups. This review provides an evidence that hyperbaric oxygen therapy is effective as an adjunct treatment measure for the diabetes foot ulcers. These findings could be generalized cautiously by considering methodological flaws within all studies.

Aims/hypothesisOur aim was to investigate amputation-free survival in people at high risk for foot ulceration in diabetes (‘high-risk foot’), and to compare different subcategories of high-risk foot.MethodsOverall, 17,353 people with diabetes and high-risk foot from January 2008 to December 2011 were identified from the Scotland-wide diabetes register (Scottish Care Information-Diabetes: N = 247,278). Participants were followed-up for up to 2 years from baseline and were categorised into three groups: (1) those with no previous ulcer, (2) those with an active ulcer or (3) those with a healed previous ulcer. Participants with prior minor or major amputation were excluded. Accelerated failure time models were used to compare amputation-free survival up to 2 years between the three exposure groups.ResultsThe 2 year amputation-free survival rate in all people with diabetes with high-risk foot was 84.5%. In this study group, 270 people (10.0%) had an amputation and 2424 (90.0%) died during the 2 year follow-up period. People who had active and healed previous ulcers at baseline had significantly lower 2 year amputation-free survival compared with those who had no previous ulcer (both p < 0.0001). The percentage of people who died within 2 years for those with healed ulcer, active ulcer or no baseline ulcer was 22.8%, 16% and 12.1%, respectively.Conclusions/interpretationIn people judged to be at high risk of foot ulceration, the risk of death was up to nine times the risk of amputation. Death rates were higher for people with diabetes who had healed ulcers than for those with active ulcers. However, people with active ulcers had the highest risk of amputation.

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. 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. 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]). 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.

Aims/hypothesis We sought to identify factors related to short-term outcome of foot ulcers in patients with diabetes treated in a multidisciplinary system until healing was achieved. Methods Consecutively presenting patients with diabetes and worst foot ulcer (Wagner grade 1–5, below ankle) ( n  = 2,511) were prospectively followed and treated according to a standardised protocol until healing was achieved or until death. The number of patients lost to dropout was 31. The characteristics of the remaining 2,480 patients were: 1,465 men, age 68 ± 15 years (range 18–96), type 1 diabetes 18%, type 2 diabetes 82% and insulin-treated 62%. Results The healing rate without major amputation in surviving patients was 90.6% ( n  = 1,867). Sixty-five per cent ( n  = 1,617) were healed primarily, 9% ( n  = 250) after minor amputation and 8% after major amputation; 17% ( n  = 420) died unhealed. Out of 2,060 surviving patients, 1,007 were neuroischaemic (48.8%). In a multiple regression analysis, primary healing was related to co-morbidity, duration of diabetes, extent of peripheral vascular disease and type of ulcer. In neuropathic ulcers, deep foot infection, site of ulcer and co-morbidity were related to amputation. Amputation in neuroischaemic ulcers was related to co-morbidity, peripheral vascular disease and type of ulcer. Age, sex, duration of diabetes, neuropathy, deformity and duration of ulcer or site of ulcer did not have an evident influence on probability of amputation. Conclusions/interpretation Patients with diabetic foot ulcer suffer from multi-organ disease. Factors related to outcome are correspondingly complex.

Background Diabetic foot ulcers (DFU) are a common problem in longstanding diabetes. However, mortality outcomes in Australian patients with DFU are still unclear. Methods All patients with DFU presenting for the first time to the Multi-Disciplinary Foot Clinic (MDFC) at Royal Darwin Hospital, Northern Territory Australia, between January 2003 and June 2015 were included in this study. These patients were followed until 2017, or death. Individual patient data was extracted from hospital and primary care information systems. Kaplan-Meier survival curves were developed. The association between various risk factors and mortality was analysed using Cox regression. Results In total 666 subjects were screened, and 513 were included in the final analysis. Of these subjects, 247 were Indigenous and 266 were non-Indigenous. The median follow-up period was 5.8 years (IQR, 3.1–9.8). The mean age at inclusion was 59.9 ± 12.3 years and 62.8% were males. The majority (93.6%) had type 2 diabetes and the median diabetes duration was 7 years (IQR, 3–12). There were 199 deaths, with a 5-year-mortality rate of 24.6%, and a 10-year-mortality rate of 45.4%. The mean age at death was 64.6 ± 11.8 years. In a multivariate analysis, the following variables were associated with mortality (adjusted HR, 95% CI): age 1.04 (1.02–1.05, P  < 0.001); chronic kidney disease 1.22 (1.11–1.33, P  < 0.001), and plasma albumin 0.96 (0.94–0.99, P  < 0.05). The most common causes of death were chronic kidney disease (24.6%), cardiovascular events (19.6%), sepsis (15.6%), respiratory failure (10.0%), malignancy (9.5%) and multi-organ failure (5.0%). Conclusion Patients with DFU have high mortality. Age, chronic kidney disease, and low albumin levels increase the risk of mortality. Strategies should focus on ulcer prevention and aggressive risk factor reduction.