Editor's Choice - Association of Pedal Acceleration Time With Healing and Amputation Free Survival in Patients With Ulceration and Gangrene.

OBJECTIVE: Pedal acceleration time (PAT) is a novel non-invasive perfusion measurement that may be useful in the management of patients with ulceration and gangrene. The objective of this study was to report the association between PAT and wound healing, amputation free survival (AFS), and mortality at one year. METHODS: This prospective observational study reviewed all patients who underwent PAT after presentation with ulceration or gangrene from 1 January 2020 to 30 June 2022. PAT was defined as the time (in milliseconds) from the onset of systole to the peak of systole in the mid artery. The final PAT of a limb was used to assess outcomes (presenting PAT if no revascularisation, or post-revascularisation PAT). Wound healing, major limb amputation, and death at one year were collected. Healing was assessed with Fine-Gray competing risks model, AFS via logistic regression, and survival using Cox proportional hazards model. RESULTS: Overall, 265 patients (307 limbs) were included. The median patient age was 71 years and 74.0% (196/265) had diabetes mellitus. Patient demographics were similar among the final PAT category cohorts. Compared with a final PAT category 1, analysis of one year outcomes showed that the final PAT categories 2 - 4 had lower wound healing (category 2, hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.43 - 0.9, p = .012; category 3, HR 0.21, 95% CI 0.08 - 0.58, p = .002; category 4, HR 0.12, 95% CI 0.04 - 0.34, p < .001), lower AFS (category 2, odds ratio [OR] 2.86, 95% CI 1.64 - 5.0, p < .001; category 3, OR 5.1, 95% CI 1.71 - 15.22, p = .003; category 4, OR 12.59, 95% CI 4.34 - 36.56, p < .001), and lower survival (category 2, HR 1.89, 95% CI 1.17 - 3.03, p =.009; category 3, HR 2.37, 95% CI 1.05 - 5.36, p = .039; category 4, HR 4.52, 95% CI 2.48 - 8.21, p < .001). CONCLUSION: The final PAT measurement is associated with wound healing, AFS, and death at one year. PAT may be a valuable tool to assess perfusion of the foot.

Denosumab, for osteoporosis, reduces the incidence of type 2 diabetes, risk of foot ulceration and all-cause mortality in adults, compared with bisphosphonates: An analysis of real-world, cohort data, with a systematic review and meta-analysis.

AIM: To evaluate the impact of denosumab on (i) the incidence of type 2 diabetes (T2D), and (ii) long-term health outcomes (microvascular [neuropathy, retinopathy, nephropathy] and macrovascular [cardiovascular disease, cerebrovascular accident] complications, and all-cause mortality) in patients with T2D, before (iii) combining results with prior studies using meta-analysis. METHODS: A retrospective analysis of data in a large global federated database (TriNetX; Cambridge, MA) was conducted from 331 375 patients, without baseline T2D or cancer, prescribed either denosumab (treatment, n = 45 854) or bisphosphonates (control, n = 285 521), across 83 healthcare organizations. Propensity score matching (1:1) of confounders was undertaken that resulted in 45 851 in each cohort. Secondary analysis further evaluated the impact of denosumab on long-term health outcomes in patients with T2D. Additionally, we systematically searched prior literature that assessed the association between denosumab and T2D. Estimates were pooled using random-effects meta-analysis. Risk of bias and evidence quality were assessed using Cochrane-endorsed tools. RESULTS: Denosumab (vs. bisphosphonates) was associated with a lower risk of incident T2D over 5 years (hazard ratio 0.83 [95% confidence interval {CI} 0.78-0.88]). Secondary analysis showed significant risk reduction in all-cause mortality (0.79 [0.72-0.87]) and foot ulceration (0.67 [0.53-0.86]). Also, pooled results from four studies (three observational, one randomized controlled trial) following meta-analysis showed a reduced relative risk (RR [95% CI]) for incident T2D in patients prescribed denosumab (0.83 [0.79-0.87]) (I2 = 10.76%). CONCLUSIONS: This is the largest cohort study to show that denosumab treatment is associated with a reduced RR of incident T2D, as well as an associated reduced RR of all-cause mortality and microvascular complications, findings that may influence guideline development in the treatment of osteoporosis, particularly in patients who are at a high risk of T2D.

Above-ankle Reamputation and Mortality following Transmetatarsal Amputation in Diabetic and Nondiabetic Peripheral Artery Disease.

The risk of above-ankle reamputation following a transmetatarsal amputation is around 30%. Patient selection may be crucial to achieve good outcomes, and to avoid futile operations and suffering. We are aware of no previous comparison between the two largest patient groups that undergo lower extremity amputations: patients with diabetes, and patients with non-diabetic peripheral artery disease. Patients with diabetes or nondiabetic peripheral artery disease who had undergone a transmetatarsal amputation from 2004 to 2018 at our institution were included. Patient characteristics and perioperative details were analyzed retrospectively. Subjects with diabetes were compared with subjects with nondiabetic peripheral artery disease regarding above-ankle reamputation, reamputation level, and mortality. Five-hundred-and-sixty transmetatarsal amputations in 513 subjects were included. The majority of transmetatarsal amputations (86%) occurred in diabetic subjects. Subjects with non-diabetic PAD had a higher risk of above-ankle reamputation (p = .008), and death (p < .001). At the time of data collection, only multiple-ray amputation (vs. single-ray) was an independent risk factor for above-ankle reamputation. Only age, medical comorbidity in general, and chronic heart failure were independent risk factors of death. To our knowledge, this study is the first to report marked differences in above-ankle reamputation rates and mortality following transmetatarsal amputation, comparing diabetics with non-diabetic patients with peripheral artery disease. However, the differences may be attributed to non-diabetics being older, having more medical comorbidities, and having more advanced foot ulcers at the time of transmetatarsal amputation. In patients exhibiting several of these risk factors, transmetatarsal amputation may be futile.

Tasa de mortalidad de personas con pie diabético en La Habana durante el periodo 2010-2015 / Mortality for Diabetic Foot in People with Diabetes Mellitus in Havana during the 2010-2015 Period

Introducción: Se define como pie diabético toda infección, úlcera o destrucción tisular del pie asociada a neuropatía y/o enfermedad vascular periférica de miembros inferiores en personas con diabetes. Objetivo: Determinar la tasa de mortalidad en personas con pie diabético en La Habana durante el período 2010-2015, así como las causas y las variables sociodemográficas de los fallecidos. Método: Estudio observacional, descriptivo y retrospectivo. Se revisó el registro de fallecidos por diabetes mellitus en La Habana como causa básica de muerte de los años comprendidos del 2010 al 2015, Se analizaron las variables edad, sexo, causa básica de muerte, amputaciones y municipio de procedencia. Los resultados se expresaron en frecuencias absolutas, relativas y tasas por 100 000 habitantes. Resultados: La tasa de mortalidad en personas con pie diabético fue de 3,07/105 habitantes. El año de mayor mortalidad fue el 2010 (10,41 por ciento) y el de menor fue el 2011 (7,34 por ciento). Predominaron las mujeres (56 por ciento) y los mayores de 70 años (66,5 por ciento). En el 48,5 por ciento de los casos se reportaron amputaciones. Las causas directas de muerte más frecuente fueron: la sepsis (34,5 por ciento), el tromboembolismo pulmonar (32,2 por ciento) y la bronconeumonía (21,1 por ciento). Los municipios con menores tasas de fallecidos fueron La Habana Vieja y Arroyo Naranjo. Conclusiones: La tasa de mortalidad en personas con pie diabético en el período 2010-2015 tuvieron una tendencia a la disminución. Las cifras más elevadas se observaron en la edad y en el sexo femenino. Las infecciones, el tromboembolismo pulmonar y la bronconeumonía fueron las causas de muerte directa más importantes(AU)

Introduction: Mortality due to diabetes mellitus may rise due to an increase in its prevalence and the risk of chronic complications. Objective: To determine the mortality rate in people with diabetic foot in Havana during the 2010-2015 period, as well as the causes and sociodemographic variables of the deceased. Methods: Observational, descriptive and retrospective study. The registry of deaths from diabetes mellitus as the basic cause of death from 2010 to 2015 was reviewed. The variables age, sex, basic cause of death, amputations and municipality of origin were analyzed. The results were expressed in absolute and relative frequencies, as well as in rates per hundred thousand inhabitants. Results: The mortality rate in people with diabetic foot was 3.07/105 inhabitants. The year with the highest mortality was 2010 (10.41 percent) and the year with the lowest value was 2011 (7.34 percent). Women (56 percent) and those aged over seventy years (66.5 percent) predominated. In 48.5 percent of the cases accounted for amputations. The most frequent direct causes of death were sepsis (34.5 percent), pulmonary thromboembolism (32.2 percent) and bronchopneumonia (21.1 percent). The municipalities with the lowest death rates were La Habana Vieja and Arroyo Naranjo. Conclusions: Mortality rates in people with diabetic foot in the 2010-2015 period tended to decrease. The highest figures were observed in geriatric ages and among women. Infections, pulmonary embolism and bronchopneumonia were the most important direct causes of death(AU)

Diabetic foot ulcer management in a multidisciplinary foot centre: one-year healing, amputation and mortality rate.

OBJECTIVE: To describe the rates of healing, major amputation and mortality after 12 months in patients with a new diabetic foot ulcer (DFU) and their care in a French diabetic foot service (DFS). METHOD: A prospective single-centre study including patients from March 2009 to December 2010. The length of time to healing, minor amputation, major amputation and mortality rate after inclusion were analysed using the Kaplan-Meier method. RESULTS: Some 347 patients were included (3% lost to follow-up), with a median follow-up (IQR) of 19 (12-24) months. The mean (SD) age was 65±12 years, 68% were male, and the median duration of the ulcer was 49 (19-120) days. Complications of the DFU were ischaemia (70%), infection (55%) and osteomyelitis (47%). Of the patients, 50% were inpatients in the DFS at inclusion (median duration of hospitalisation 26 (15-41) days). The rate of healing at one year was 67% (95% confidence interval (CI): 61-72); of major amputation 10% (95% CI: 7-17); of minor amputation 19% (95% CI: 14-25), and the death rate was 9% (95% CI: 7-13). Using an adjusted hazard ratio, the predictive factors of healing were perfusion and the area of the wound. The risk factors for a major amputation were active smoking and osteomyelitis. The risk factors for mortality were perfusion and age. CONCLUSION: This study confirms the need to treat DFUs rapidly, in a multidisciplinary DFS.

A Systematic Review and Narrative Synthesis of Risk Prediction Tools Used to Estimate Mortality, Morbidity, and Other Outcomes Following Major Lower Limb Amputation.

OBJECTIVE: The decision to undertake a major lower limb amputation can be complex. This review evaluates the performance of risk prediction tools in estimating mortality, morbidity, and other outcomes following amputation. METHODS: A systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The MEDLINE, Embase, and Cochrane databases were searched to identify studies reporting on risk prediction tools that predict outcomes following amputation. Outcome measures included the accuracy of the risk tool in predicting a range of post-operative complications, including mortality (both short and long term), peri-operative morbidity, need for re-amputation, and ambulation success. A narrative synthesis was performed in accordance with the Guidance on the Conduct of Narrative Synthesis In Systematic Reviews. RESULTS: The search identified 518 database records. Twelve observational studies, evaluating 13 risk prediction tools in a total cohort of 61 099 amputations, were included. One study performed external validation of an existing risk prediction tool, while all other studies developed novel tools or modified pre-existing generic calculators. Two studies conducted external validation of the novel/modified tools. Nine tools provided risk estimations for mortality, two tools provided predictions for post-operative morbidity, two for likelihood of ambulation, and one for re-amputation to the same or higher level. Most mortality prediction tools demonstrated acceptable discrimination performance with C statistic values ranging from 0.65 to 0.81. Tools estimating the risk of post-operative complications (0.65 - 0.74) and necessity for re-amputation (0.72) also performed acceptably. The Blatchford Allman Russell tool demonstrated outstanding discrimination for predicting functional mobility outcomes post-amputation (0.94). Overall, most studies were at high risk of bias with poor external validity. CONCLUSION: This review identified several risk prediction tools that demonstrate acceptable to outstanding discrimination for objectively predicting an array of important post-operative outcomes. However, the methodological quality of some studies was poor, external validation studies are generally lacking, and there are no tools predicting other important outcomes, especially quality of life.

Evaluating the Impact of Medial Arterial Calcification on Outcomes of Infrageniculate Endovascular Interventions for Treatment of Diabetic Foot Ulcers.

BACKGROUND: Medial arterial calcification (MAC) of the tibial and pedal arteries has been associated with an increased risk of amputation among people with diabetes. Endovascular interventions on infrageniculate vessels are frequently performed with the intent of treating peripheral artery disease (PAD) and decreasing the risk of amputation in those with diabetes. This study aimed to investigate how the extent of MAC impacts outcomes of endovascular procedures in people with diabetic foot ulcers (DFU). METHODS: We identified all patients who had undergone infrageniculate angioplasty in the setting of DFU at our institution between 2009 and 2019. Subjects were assigned a MAC score based on the severity of MAC in each vessel visualized on plain radiographs of the ankle and foot. We evaluated the relationship between MAC and the primary outcome, major adverse limb event (MALE), using stratified Cox proportional modeling. RESULTS: Among 99 subjects with DFU who had undergone infrageniculate angioplasty, MALE occurred in 50% (95% confidence interval [CI] 38%-61%) of patients within 1 year of intervention. On univariate Cox regression analysis, each 1 point increment in MAC score (hazard ratio [HR], 1.09; 95% CI 1.01-1.18), the third tertile of MAC score (HR, 2.27; 95% CI 1.01-5.11), age (HR 0.96; 95% CI 0.93-0.99), and wound grade (HR, 5.34; 95% CI 2.17-13.14), were significantly associated with increased risk of MALE. On adjusted analysis stratified by wound grade, MAC score was found to be associated with MALE only in patients with a low wound grade. CONCLUSION: Increased severity of MAC is associated with increased risk of MALE for subjects undergoing infrageniculate angioplasty with a low wound grade. Further research is needed to better understand the complex relationships of MAC, PAD, DFU, and interventions aimed at promoting healing of DFU.

Healing and Mortality Rates Following Toe Amputation in Type 2 Diabetes Mellitus.

BACKGROUND AND AIM: This single-centre study aimed to determine healing, re-ulceration, re-amputation and mortality rates at one year after toe amputations in patients with type 2 diabetes (T2DM). PATIENTS AND METHODS: Eighty-one participants with T2DM admitted for toe amputation were included. Patient characteristics, peripheral circulation and neuropathy status were recorded. Subjects were then followed every 3 months post-amputation for a year. RESULTS: Overall, 59.3% of participants underwent further surgery (n=31 to revise the original amputation site and n=17 to amputate a new site). During 12 months, 45.7% of participants presented with a new ulcer at a different site. Mortality was 7.4%. In 12.4% of participants, the amputation site remained incompletely healed. Only 20.9% had no complications in 12 months. At 12 months, 80.2% of study cohort had a completely healed amputation site. CONCLUSION: In conclusion, this study highlighted high re-intervention, re-amputation and new ulceration rates. Strategies to improves these outcomes in such high-risk patients are warranted.

Diabetic foot ulcer management in a multidisciplinary foot centre: one-year healing, amputation and mortality rate.

OBJECTIVE: To describe the rates of healing, major amputation and mortality after 12 months in patients with a new diabetic foot ulcer (DFU) and their care in a French diabetic foot service (DFS). METHOD: A prospective single-centre study including patients from March 2009 to December 2010. The length of time to healing, minor amputation, major amputation and mortality rate after inclusion were analysed using the Kaplan-Meier method. RESULTS: Some 347 patients were included (3% lost to follow-up), with a median follow-up (IQR) of 19 (12-24) months. The mean (SD) age was 65±12 years, 68% were male, and the median duration of the ulcer was 49 (19-120) days. Complications of the DFU were ischaemia (70%), infection (55%) and osteomyelitis (47%). Of the patients, 50% were inpatients in the DFS at inclusion (median duration of hospitalisation 26 (15-41) days). The rate of healing at one year was 67% (95% confidence interval (CI): 61-72); of major amputation 10% (95% CI: 7-17); of minor amputation 19% (95% CI: 14-25), and the death rate was 9% (95% CI: 7-13). Using an adjusted hazard ratio, the predictive factors of healing were perfusion and the area of the wound. The risk factors for a major amputation were active smoking and osteomyelitis. The risk factors for mortality were perfusion and age. CONCLUSION: This study confirms the need to treat DFUs rapidly, in a multidisciplinary DFS.

A meta-analysis of mortality after minor amputation among patients with diabetes and/or peripheral vascular disease.

OBJECTIVE: Foot complications in patients with diabetes or peripheral artery disease (PAD) are serious events in the life of these patients that often lead to amputations and mortality. No evidence synthesis has been reported on the mortality rates after minor lower extremity amputation; thus, a quantitative evidence synthesis was needed. METHODS: A systematic literature search was performed to identify studies that had reported the survival or mortality rates after a minor LEA. The studies were required to include one or more of the following primary outcomes: mortality rate at 30 days, 1 year, 3 years, 5 years, 6 to 7 years, or 8 to 9 years. The secondary outcomes were the mortality rates according to the anatomic location of the amputation in the foot and the independent risk factors for mortality. RESULTS: A total of 28 studies with 17,325 subjects fulfilled the inclusion criteria. The meta-analytical results of the mortality rates were as follows: 3.5% at 1 month, 20% at 1 year, 28% at 3 years, 44.1% at 5 years, 51.3% at 6 to 7 years, and 58.5% at 8 to 9 years. From these studies of diabetic patients, age was the most consistent independent risk factor, followed by chronic kidney disease, PAD, and coronary artery disease. One study of patients with PAD had reported diabetes as an independent risk factor for mortality. The subgroup analysis of the four studies reporting the outcomes of patients with PAD showed greater 3- and 5-year mortality rates compared with the overall and "diabetic" results. CONCLUSIONS: Mortality after minor amputation for patients with diabetes and/or PAD was found to be very high. Compared with the reported cancer data, survival was worse than that for many cancers. Just as in the case of major amputations, minor amputations should be considered a pivotal event in the life of these patients.

Diabetic foot surgery "Made in Italy". Results of 15 years of activity of a third-level centre managed by diabetologists.

AIM: To evaluate clinical outcomes in patients who underwent diabetic foot surgery (DFS) managed directly by diabetologists in a third-level Centre over 15-year. METHODS: We retrospectively evaluated 1.857 patients affected by diabetic foot (Age 67.1 ± 12.3 yrs, diabetes duration 19.2 ± 9.8 yrs, HbA1c 8.1 ± 2.0%) treated in our Department between 2001 and 2015 and divided them into 3 groups: Group 1, treated between 2001 and 2005 (448 pts), group 2, between 2006 and 2010 (540 pts) and Group 3, between 2011 and 2015 (869 pts). Main clinical outcomes [peripheral revascularization rate (PR), healing rate (HR), healing time (HT), recurrences after healing (R), major amputation (MA) and death (D) rates] were compared between groups. RESULTS: The overall outcomes of our cohort were: HR 81.6% (HT 143 ± 54 days), PR 84.8%, MA 4.9% and D 27.9%. There were no differences in clinical characteristics, except for age, higher (p < 0.05) in Group 3 (70.6 ± 14.7 yrs) than in Groups 1 (64.4 ± 11.6 yrs) and 2 (65.1 ± 11.2 yrs). No differences emerged when comparing HR and MA; HT was shorter (p < 0.05) in group 3 (104 ± 44 days) than in Group 2 (169 ± 72 days) and 1 (235 ± 67 days). D was higher (p < 0.05) in Group 3 (43.8%) than in Group 1 (23.1%) and 2 (28.1%). PR was 19.4% in Group 1, 28.1% in Group 2 and 53.8% in Group 3 (p < 0.05). CONCLUSIONS: Despite the increasing age and complexity of patients our data show improvement of outcomes throughout 15 years, probably due to better surgical techniques, more aggressive medical therapy and more effective treatment of critical limb ischemia.

Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer.

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.

Short-term contemporary outcomes for staged versus primary lower limb amputation in diabetic foot disease.

BACKGROUND: Major lower extremity amputations remain among the most common procedures performed by vascular surgeons in patients with diabetes and its associated peripheral vascular disease. After major amputation, this population commonly suffers from high readmission rates, increased wound complications, and conversion to more proximal major amputations. These events impact quality in terms of cost, resources, and subjective quality of life. The aim of this study is to compare outcomes between primary lower extremity above-ankle amputations (primary amputation [PA]) and staged ankle guillotine amputations followed by interval formalization to an above-ankle amputation (staged amputation [SA]) for nonsalvageable infected diabetic foot disease. METHODS: A retrospective review of all de novo major lower extremity amputations performed by the vascular surgery service at a single institution between January 2014 and March 2017 was performed. Inclusion criteria were diabetic patients with foot gangrene who underwent a major de novo above- or below-knee amputation. Amputations for trauma, acute limb ischemia, or malignancy were excluded. Per institutional practice, SA was performed for uncontrolled infection and/or infection with uncontrolled diabetes, and PA was performed in the absence of active infection and in stable diabetes. The primary outcome measure was 30-day freedom from conversion to a higher level amputation. Secondary outcome measures were 30-day stump complications, 30-day readmissions, 30-day major adverse cardiovascular events, and 30-day mortality. RESULTS: One hundred sixteen patients met the inclusion criteria. Sixty-eight percent were male, 18% were active smokers, 30% had end-stage renal disease, and 22% had congestive heart failure. Sixty-one patients underwent SA, and 55 patients underwent PA. The two cohorts were well-matched by demographics and comorbidities. Consistent with the institutional practice, 57% of SA patients met two or more systemic inflammatory response syndrome criteria at presentation compared with 24% of PA patients (P = .0003). There were no 30-day mortalities. There was no significant difference in major adverse cardiovascular events between the groups (2% vs 4%; SA vs PA, respectively; P = .6). The average length of stay did not significantly differ between SA and PA (mean of 14 ± 8 days vs 11 ± 11 days; P = .1). SA patients had a lower rate of 30-day readmission (7% vs 27%; P = .005) and 30-day unplanned conversion to higher level amputation (2% vs 13%; P = .026) compared with PA patients. CONCLUSIONS: In the setting of infected diabetic foot disease, a staged lower extremity amputation achieves quality outcomes superior to a one-stage amputation, despite the former cohort's greater illness acuity level. SA should be considered in all diabetic patients presenting with active foot infection.

Procalcitonin Is a Prognostic Marker of Hospital Outcomes in Patients with Critical Limb Ischemia and Diabetic Foot Infection.

AIM: To evaluate the prognostic role of procalcitonin (PCT) in patients with diabetic foot infection (DFI) and critical limb ischemia (CLI). MATERIALS AND METHODS: The study group was composed of diabetic patients with DFI and CLI. All patients were treated according to a preset limb salvage protocol which includes revascularization, wound debridement, antibiotic therapy, and offloading. Inflammatory markers, including PCT, were evaluated at admission. Only positive values of PCT, greater than 0.5 ng/ml, were considered. Hospital outcomes were categorized as limb salvage (discharge with preserved limb), major amputation (amputation above the ankle), and mortality. RESULTS: Eighty-six patients were included. The mean age was 67.3 ± 11.4 years, 80.7% were male, 95.1% had type 2 diabetes, and the mean diabetes duration was 20.5 ± 11.1 with a mean HbA1c of 67 ± 16 mmol/mol. 66/86 (76.8%) of patients had limb salvage, 7/86 (8.1%) had major amputation, and 13/86 (15.1%) died. Patients with positive PCT baseline values in comparison to those with normal values showed a lower rate of limb salvage (30.4 versus 93.6%, p = 0.0001), a higher rate of major amputation (13 versus 6.3%, p = 0.3), and a higher rate of hospital mortality (56.5 versus 0%, p < 0.0001). At the multivariate analysis of independent predictors found at univariate analysis, positive PCT was an independent predictor of major amputation [OR 3.3 (CI 95% 2.0-5.3), p = 0.0001] and mortality [OR 4.1 (CI 95% 2.2-8.3), p < 0.0001]. DISCUSSION: Positive PCT at admission increased the risk of major amputation and mortality in hospital patients with DFI and CLI.

Utility of skin perfusion pressure values with the Society for Vascular Surgery Wound, Ischemia, and foot Infection classification system.

OBJECTIVE: The addition of skin perfusion pressure (SPP) might enhance the predictive value of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system. The purpose of the present study was to evaluate the SPP for each WIfI classification stage among patients with foot wounds by cross-referencing the results of prospectively monitored limb outcomes and to derive the SPP criteria that could be combined with other measurements to grade ischemia for the WIfI classification. METHODS: From July 2015 to June 2017, patients with foot wounds that met the WIfI classification criteria were prospectively enrolled. We assessed the limbs using the WIfI ischemia grade without measuring the transcutaneous oxygen pressure but measured the SPP. After monitoring for 1 year, the predictability of the WIfI stages was analyzed according to whether the limbs had not healed (unchanged or worsened wounds, minor or major amputation, all-cause death) or had healed (improved or healed wounds) by comparing stages 1 and 2 with stages 3 and 4. We also statistically analyzed the SPP values that could be the boundary values between each ischemia grade and reevaluated the predictability of the WIfI stages with the boundary SPP values. RESULTS: We enrolled a total of 91 limbs for 76 patients (mean age, 70.5 ± 12.0 years). The mean SPP values stratified by ischemia grade 0 to 3 were 52.1, 41.1, 27.1, and 18.8 mm Hg, respectively (an SPP of <30 mm Hg indicates severe ischemia). After monitoring for 1 year, 19 of 48 limbs in stage 1 and 2 and 35 of 43 in stage 3 and 4 were in the nonhealed group and 29 limbs in stage 1 and 2 and 8 limbs in stage 3 and 4 were in the healed group. The SPP boundary values between each ischemia (I) grade were calculated as 45 mm Hg for I-0/I-1, 35 for I-1/I-2, and 25 for I-2/I-3. When jointly using the boundary SPP values, the ischemia grade changed for 23 limbs, altering the distribution of the WIfI stages and limb outcomes: 11 of 38 limbs in stage 1 and 2 and 43 of 53 in stage 3 and 4 were transferred to the nonhealed group. The sensitivity, efficiency, and negative predictive value of WIfI staging improved when staging with SPP: from 65% to 80%, 70% to 77%, and 60% to 71%, respectively. CONCLUSIONS: The SPP boundary values that could be used with ischemia grade in the WIfI classification were identified as 45, 35, and 25 mm Hg. The addition of SPP could improve the accuracy of the evaluation.

Outcome of trans-metatarsal amputations in patients with diabetes mellitus.

BACKGROUND: This retrospective case series reports the reoperation rate, survival rate and mobility status in patients with diabetes mellitus who had undergone a trans-metatarsal amputation (TMA) managed within a diabetic foot care service. METHODS: Forty-one consecutive patients (37 men, 4 women) underwent a TMA with primary wound closure between January 2008 and December 2017. Eighty-eight per cent (36/41) of the patients were followed-up for a mean of 2.3 years. The outcomes were retrospectively reviewed. RESULTS: Four (11%) of the 36 patients required reoperation, including three (8%) major amputations. All of the patients requiring a reoperation had peripheral vascular disease. Eleven patients died giving a four-year survival rate of 69% (25/36). Of the surviving patients who had not required revision to a major amputation 96% (21/22) were fully mobile in bespoke orthoses. A third used a walking cane. CONCLUSION: This study shows that a TMA with primary wound closure in patients with diabetes mellitus, is effective for limb salvage with low reoperation and major amputation rates. A well healed TMA stump provides independent mobility in the majority of patients. The failures occurred in patients with peripheral vascular disease who, even after percutaneous trans-luminal angioplasty, had a 19% major amputation rate. LEVEL OF EVIDENCE: Level IV, retrospective case series.

Mortality prediction following non-traumatic amputation of the lower extremity.

BACKGROUND: Patients who undergo lower extremity amputation secondary to the complications of diabetes or peripheral artery disease have poor long-term survival. Providing patients and surgeons with individual-patient, rather than population, survival estimates provides them with important information to make individualized treatment decisions. METHODS: Patients with peripheral artery disease and/or diabetes undergoing their first unilateral transmetatarsal, transtibial or transfemoral amputation were identified in the Veterans Affairs Surgical Quality Improvement Program (VASQIP) database. Stepdown logistic regression was used to develop a 1-year mortality risk prediction model from a list of 33 candidate predictors using data from three of five Department of Veterans Affairs national geographical regions. External geographical validation was performed using data from the remaining two regions. Calibration and discrimination were assessed in the development and validation samples. RESULTS: The development sample included 5028 patients and the validation sample 2140. The final mortality prediction model (AMPREDICT-Mortality) included amputation level, age, BMI, race, functional status, congestive heart failure, dialysis, blood urea nitrogen level, and white blood cell and platelet counts. The model fit in the validation sample was good. The area under the receiver operating characteristic (ROC) curve for the validation sample was 0·76 and Cox calibration regression indicated excellent calibration (slope 0·96, 95 per cent c.i. 0·85 to 1·06; intercept 0·02, 95 per cent c.i. -0·12 to 0·17). Given the external validation characteristics, the development and validation samples were combined, giving a total sample of 7168. CONCLUSION: The AMPREDICT-Mortality prediction model is a validated parsimonious model that can be used to inform the 1-year mortality risk following non-traumatic lower extremity amputation of patients with peripheral artery disease or diabetes.

Multidisciplinary clinics reduce treatment costs and improve patient outcomes in diabetic foot disease.

OBJECTIVE: Diabetic foot disease poses a significant and rising financial burden on health care systems worldwide. This study investigated the effect of a new multidisciplinary diabetic foot clinic (MDDFC) in a large tertiary hospital on patient outcomes and treatment cost. METHODS: Patients' records were retrospectively reviewed to identify all patients who had been managed in a new MDDFC between July 2014 and July 2017. The wound episode-the period from initial presentation to the achievement of a final wound outcome-was identified, and all relevant inpatient and outpatient costs were extracted using a fully absorbed activity-based costing methodology. Risk factor, treatment, outcome, and costing data for this cohort were compared with a group of patients with diabetic foot wounds who had been managed in the same hospital before the advent of the MDDFC using a generalized linear mixed model. RESULTS: The MDDFC and pre-MDDFC cohorts included 73 patients with 80 wound episodes and 225 patients with 265 wound episodes, respectively. Compared with the pre-MDDFC cohort, the MDDFC group had fewer inpatient admissions (1.56 vs 2.64; P ≤ .001). MDDFC patients had a lower major amputation rate (3.8% vs 27.5%; P ≤ .001), a lower mortality rate (7.5% vs 19.2%; P ≤ .05), and a higher rate of minor amputation (53.8% vs 31.7%; P ≤ .01). No statistically significant difference was noted in the rate of excisional débridement, skin graft, and open or endovascular revascularization. In the MDDFC cohort, the median total cost, inpatient cost, and outpatient cost per wound episode was New Zealand dollars (NZD) 22,407.465 (U.S. dollars [USD] 17,253.74), NZD 21,638.93 (USD 16,661.97), and NZD 691.915 (USD 532.77), respectively. The MDDFC to pre-MDDFC wound episode total cost ratio was 0.7586 (P < .001). CONCLUSIONS: This study is the first to compare the cost and treatment outcomes of diabetic foot patients treated in a large tertiary hospital before and after the introduction of an MDDFC. The results show that an MDDFC improves patient outcomes and reduces the cost of treatment. MDDFCs should be adopted as the standard of care for diabetic foot patients.

Mortality in patients with diabetic foot ulcer: a retrospective study of 513 cases from a single Centre in the Northern Territory of Australia.

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.