Epidermal growth factor intralesional infiltrations can prevent amputation in patients with advanced diabetic foot wounds

This study examined if a series of epidermal growth factor (EGF) local infiltrations can enhance the healing process of complicated diabetic wounds. Twenty-nine in-hospital patients with diabetic neuropathic or ischaemic lesions with high risk of amputation were treated in a non controlled pilot study conducted at the National Institute of Angiology, Havana. Lesions, classified as Wagner's grade 3 or 4, included ulcers > or = 20 cm2 for > or = 25 days or amputation residual bases > or = 30 cm2 for > or = 15 days, healing refractory despite comprehensive wound care. EGF (25 microg) intralesional infiltrations (approximately 250 microl of a 25 microg/ml solution/injection point) were performed thrice weekly up to the eighth week. Wound closure was monitored during the treatment and recurrence examined for a year following discharge from hospital. Eighty-six per cent of the patients treated showed a productive granulation at infiltration session 8. Histological examination at this point indicated a substantial wound matrix transformation, granulation tissue cell repopulation and angiogenesis. Of the 29 patients treated, amputation was prevented in 17 (58.6%) of them who completed 24 infiltration sessions. They averaged 71.1 +/- 18.3% of reepithelisation during a mean in-hospital period of 66.5 +/- 4.9 days. Wound recurrence after 1 year of follow-up appeared in only one patient. Preliminary evidences suggest that EGF intralesional infiltrations may be effective in reducing diabetic lower limb amputation.     

Clinical outcomes of toe amputation in patients with type 2 diabetes in Tianjin,China

The aim of this study is to determine the predictors for reulceration, reamputation and mortality in patients with diabetes following toe amputation, and the impact of activities of daily living on clinical outcomes. This prospective cohort study included 245 patients who had undergone toe amputation (202 healing and 43 non‐healing) and was followed for a 5‐year period. Data regarding new foot ulceration, reamputation and mortality were recorded, and the patients' activities of daily living were evaluated. The rate of wound healing was 82·4%. The rate of follow‐up in the healed group was 91·6%. In years 1, 3 and 5, the cumulative incidence of patients who developed a new foot ulcer was 27·3%, 57·2% and 76·4%, respectively, leading to reamputation in 12·5%, 22·3% and 47·1%, respectively. The cumulative mortality was 5·8%, 15·1% and 32·7% at 1, 3 and 5 years, respectively. Multivariate analysis showed that GHbA1c > 9% (75 mmol/mol) was identified as an independent predictor of impaired wound healing, reulceration and reamputation. An age of >70 years was identified as an independent predictor of reamputation, mortality and impairment of activities of daily living. Despite a satisfactory initial healing rate after the first toe amputation, with the extension course after the toe amputation, the long‐term outcomes are not optimistic. In developing countries like China, taking measures to prevent reulceration and reamputation is very important for patients with diabetic foot minor amputations, especially following toe amputation.     

Tumor-Stroma Ratio is an independent predictor for overall survival and disease free survival in gastric cancer patients

Background

Despite different prognostic factors have been already studied, patients undergoing potentially curative resection for gastric cancer, still have a poor outcome. There is therefore the need to identify novel prognostic factors. Recently, Tumor-Stroma Ratio (TSR) was proven to be associated with prognosis in different types of cancers. Aim of this study was to evaluate the prognostic value of TSR in gastric cancer patients.

SVS WIfI score as a predictor of amputation after onset of CLI: Validation in an Irish tertiary vascular unit

IntroductionCritical limb ischemia (CLI) in diabetic patients is defined by non-healing foot ulcer or rest pain for more than 2 weeks with ankle pressure of less than 40 mmHg. The SVS WIfI classification system stratifies CLI on the basis of perfusion, extent of wound and superadded infection to provide a composite score which guides further management and predicts final prognosisObjectiveThe aim of the study was to use the SVS WIfI scoring system to predict the need for early revascularization versus early amputation depending on the composite WIfI score at presentation.MethodologyThis was a retrospective observational study. Data was collected on patients admitted with CLI, in the last 2 years, to calculate composite WIfI score. The WIfI categories according to risk of limb loss were identified with endpoint being major or minor amputation.ResultsAmong the 87 patients reviewed, 35 patients (40%) required major amputation, and 29 of those underwent vascular intervention (83%) as part of their care. Median age of the cohort was 72 and 71% were male patients. Comparative analysis between major amputations and minor amputation showed the median score on initial clinical presentation to be 7 in major amputation and 5 in minor amputations (p < 0.0001).ConclusionThe composite WIFi score (a summation of the Wound, Ischaemia, and Infection sub-scores) was a good predictor of need for an amputation WIfI scoring system is a useful tool and should be used early in the management of infected ischaemic limbs.     

Validation of a nomogram to predict disease progression following salvage radiotherapy after radical prostatectomy: results from the SEARCH database

OBJECTIVE

To externally validate the nomogram published by Stephenson et al. (termed the ‘Stephenson nomogram’) to predict disease progression after salvage radiotherapy (SRT) among patients with prostate cancer from the Shared Equal Access Regional Cancer Hospital (SEARCH) database.

PATIENTS AND METHODS

We analysed data from 102 men treated with SRT for prostate‐specific antigen (PSA) failure after prostatectomy, of whom 30 (29%) developed disease progression after SRT during a median follow‐up of 50 months. The predicted 6‐year progression‐free survival (PFS) was compared to the actuarial PFS using calibration plots. The accuracy of the nomogram to risk‐stratify men for progression was assessed by the concordance index.

RESULTS

The median PSA and PSA doubling time before SRT was 0.6 ng/mL and 10.3 months, respectively. The 6‐year actuarial disease‐free progression after SRT was 57% (95% confidence interval 42–69%). The overall concordance index of the Stephenson nomogram was 0.65. The nomogram predicted failure more accurately at the extremes of risk (lowest and highest) but in intermediate groups, the accuracy was less precise. Of the 11 variables used in the nomogram, only negative margins and high PSA level before SRT were significantly associated with increased disease progression.

CONCLUSION

The Stephenson nomogram is an important tool to predict disease progression after SRT following radical prostatectomy. It adequately predicted progression in SEARCH with reasonable accuracy. Also, in SEARCH, disease progression was predicted by similar disease characteristics. However, the overall modest performance of the model in our validation cohort indicates there is still room for improvement in predictive models for disease progression after SRT.     

Secondary reconstruction of below knee amputation stump with free anterolateral thigh flap

Below knee stump preservation reduces ambulatory energy expenditure and improves the quality of life. Reconstruction of soft tissue loss around the stump is a challenging task. Below knee stump reconstruction demands stable skin with sufficient soft tissue to allow weigh bearing. Microsurgical tissue transfer is increasingly being used as a salvage option. Anterolateral thigh flap with additional vastus lateralis muscle provides extra cushioning effect. We report two cases of amputation below knee successfully salvaged. The anterolteral flap with abundant tissue and stable skin offers a reliable option for cover. Two patients with below knee amputation were reconstructed secondarily. After 6 to 20 months of follow -up, stumps showed no signs of pressure effects. Patients are able to bear 50-70 hours of weight per week.     

Outcomes of allogenic acellular matrix therapy in treatment of diabetic foot wounds: an initial experience

The purpose of this study was to evaluate outcomes of persons with UT grade 2A neuropathic diabetic foot wounds treated with an acellular matrix. Data were abstracted for 17 consecutive patients with diabetes--76.5% males, aged 61.5 +/- 8.5 years with a mean glycated haemoglobin of 9.2 +/- 2.2% presenting for care at a large, multidisciplinary wound care centre. All patients received surgical debridement for their diabetic foot wounds and were placed on therapy consisting of a single application of an acellular matrix graft (GraftJacket; Wright Medical Technologies, Arlington, TN, USA) with dressing changes taking place weekly. Outcomes evaluated included time to complete wound closure and proportion of patients achieving wound closure in 20 weeks. Acellular matrix therapy was used as initial therapy and was sutured or stapled in place under a silicone-based non adherent dressing. Therapy was then followed by a moisture-retentive dressing until complete epithelialisation. In total, 82.4% of wounds measuring a mean 4.6 +/- 3.2 cm(2) healed in the 20-week evaluation period. For those that healed in this period, healing took place in a mean 8.9 +/- 2.7 weeks. We conclude that a regimen consisting of moist wound healing using an acellular matrix dressing may be a useful adjunct to appropriate diabetic foot ulcer care for deep, non-infected, non-ischaemic wounds. We await the completion of further trials in this area to confirm or refute this initial assessment.     

Geographic variation in amputation rates among patients with diabetes and/or peripheral arterial disease in the rural state of West Virginia identifies areas for improved care

ObjectiveAmputation is a devastating but preventable complication of diabetes and peripheral arterial disease (PAD). Multiple studies have focused on disparities in amputation rates based on race and socioeconomic status, but few focus on amputation trends in rural populations. The objective of this study was to identify the prevalence of major and minor amputation among patients admitted with diabetes and/or PAD in a rural, Appalachian state, and to identify geographic areas with higher than expected major and minor amputations using advanced spatial analysis while controlling for comorbidities and rurality.MethodsPatient hospital admissions of West Virginia residents with diagnoses of diabetes and/or PAD and with or without an amputation procedure were identified from the West Virginia Health Care Authority State Inpatient Database from 2011 to 2016 using relevant International Classification of Diseases, 9th edition and 10the edition codes. Bayesian spatial hierarchical modeling was conducted to identify areas of high risk, while controlling for important confounders for amputation.ResultsOverall, there were 5557 amputations among 459,452 hospital admissions with diabetes and/or PAD from 2011 to 2016. The majority of the amputations were minor (61.7%; n = 3430), with a prevalence of 7.5 per 1000 and 40.4% (n = 2248) were major, with a prevalence of 4.9 per 1000. Geographic analysis found significant variation in risk for both major and minor amputation across the state, even after adjusting for the prevalence of risk factors. Analyses indicated an increased risk of amputation in the central and northeastern regions of West Virginia at the county level, although zip code-level patterns of amputation varied, with high-risk areas identified primarily in the northeastern and south central regions of the state.ConclusionsThere is significant geographic variation in risk of amputation across West Virginia, even after adjusting for disease-related risk factors, suggesting priority areas for further investigation. The level of granularity obtained using advanced spatial analyses rather than traditional methods demonstrate the value of this approach, particularly when risk estimates are used to inform policy or public health intervention.     

Characteristics of a large cohort of patients with diabetes having at‐risk feet and outcomes in patients with foot ulceration referred to a tertiary care diabetes unit

To identify in a large population cohort the clinical and biochemical characteristics of patients with diabetes at risk of foot ulceration and outcomes in those with foot ulcers. All patients with diabetes attending Baqai Institute of Diabetology and Endocrinology from January 2004 to April 2012 included in the study. Clinical, biochemical and socio‐demographic data were collected and patients were categorised into those at no risk of ulceration, at risk of ulceration and those with foot ulcer, according to the University of Texas classification. Patients with foot ulceration followed for their final outcome, that is complete healing, persisted non‐healed ulcer, lower extremity amputation, lost to follow‐up or death. A total of 18 119 patients with diabetes underwent assessment, 3576 (19·7%) patients defined as at high risk for foot ulceration and 3731 (20·6%) presented with foot ulcer. Age, male gender, hypertension, higher glycated haemoglobin (HbA1c), history of smoking and presence of neuropathy were risk factors (P < 0·000) for foot ulceration. Amputation rate in patients with foot ulceration was significantly related to severity of ulceration at presentation. Preventive foot care practices were followed by 19·02% patients. One thousand eight hundred seventy three (50·2%) patients completely healed, 293 (11%) patients underwent amputation and 397 (10·1%) patients continued to be treated in the foot clinic. All patients with diabetes should be screened for neuropathy to identify those at risk of foot ulceration, as it is the major contributory factor for foot ulceration. The final outcome of foot ulceration was determined by the severity and grade of ulcer at presentation.     

Risk factors for amputation in patients with diabetic foot infection: a prospective study

There is a variety of diagnostic and therapeutic algorithms for diabetic foot infections (DFIs). Some of them are too difficult to be applied in routine clinical approach. In the routine clinical approach, it is necessary to find new risk factors and end up with a quick and easy assessment of DFIs. In this study, we aimed to evaluate the independent risk factors for osteomyelitis, amputation and major amputation in patients with DFI using standard scoring procedures. We prospectively studied 379 patients with DFI. The variables were analysed using logistic analysis. A total of 126 cases (33·2%) underwent amputation. The odds ratios in the amputation model were 3·09 for osteomyelitis (P < 0·001), 4·90 for arterial stenosis (AS) (P < 0·001), 3·67 for the history of DFI (P = 0·001), 2·47 for ulcer duration >60 days (P = 0·001), 3·10 for ulcer depth > 15 mm (P < 0·001) and 10·28 for fungal DFI (P = 0·015). In this study, the unusual result of well‐known literature was fungal DFI as an independent risk factor for amputation in patients with DFI.     

Analysis of risk factors for amputation in patients with diabetic foot ulcers: a cohort study from a tertiary center

Objective: This study aimed to analyze risk factors for amputation (overall, minor and major) in patients with diabetic foot ulcers (DFUs).Methods: 407 patients with DFUs (286 male, 121 female; mean age = 60, age range = 32-92) who were managed in a tertiary care centre from 2009 to 2019 were retrospectively identified and included in the study. DFUs were categorized based on the Meggit-Wagner, PEDIS, S(AD)SAD, and University of Texas (UT) classification systems. To identify amputation risk-related factors, results of patients with DFUs who underwent amputations (minor or major) were compared to those who received other adjunctive treatments using Chi-Square, one-way analysis of variance (ANOVA) and Spearman correlation analysis.Results: The mean C-reactive protein (CRP) and White Blood Cell (WBC) values were significantly higher in patients with major or minor amputation than in those without amputation. The mean Neutrophil (PNL), Platelets (PLT), wound width, creatinine and sedimentation (ESR) values were significantly higher in patients with major amputation compared to other groups of patients. Elevated levels of High-density lipoprotein (HDL), Hemoglobin (HGB) and albumin were determined to be protective factors against the risk of amputation. Spearman correlation analysis revealed a positive-sided, strong-levelled, significant relation between Wagner grades and amputation status of patients.Conclusion: This study has identified specific factors for major and minor amputation risk of patients with DFUs. Especially infection markers such as CRP, WBC, ESR and PNL were higher in the amputation group. Most importantly, Meggit Wagner, one of the four different classification systems used in the DFUs, was determined to be highly associated with patients’ amputation risk.Level of Evidence: Level IV, Prognostic Study     

The impact of foot ulceration and amputation on mortality in diabetic patients. I: From ulceration to death,a systematic review

A great deal of emphasis, clinical and financial, is placed on limb salvage efforts in diabetic patients suffering from lower extremity ulceration. This is because of the impression that amputation in such patients may be a proximal cause of death. While amputation is certainly a negative clinical outcome, it is not entirely clear that it causes death. In this systematic review, we examine the available literature to attempt to understand the role that the ulceration itself may play in mortality. In brief, we searched for human studies in OVID, CINAHL and the COCHRANE CENTRAL DATABASE from 1980 to 2013, looking for articles related to ulcer or wound of the foot, in patients with diabetes or peripheral vascular disease, and death. We looked for articles with 5 years of follow‐up, or Kaplan–Meier estimates of 5‐year mortality, and excluded reviews and letters. Articles were assessed for quality and potential bias using the Newcastle–Ottawa scale. We find that while the patient populations studied varied widely in terms of demographics and comorbidities, limiting generalisability, 5‐year mortality rates after ulceration were around 40%. Risk factors for death commonly identified were increased age, male gender, peripheral vascular disease and renal disease.     

Podiatrist care and outcomes for patients with diabetes and foot ulcer

We examined whether outcomes of care (amputation and hospitalisation) among patients with diabetes and foot ulcer differ between those who received pre‐ulcer care from podiatrists and those who did not. Adult patients with diabetes and a diagnosis of a diabetic foot ulcer were found in the MarketScan Databases, 2005–2008. Multivariate Cox proportional hazard models estimated the hazard of amputation and hospitalisation. Logistic regression estimated the likelihood of these events. Propensity score weighting and regression adjustment were used to adjust for potentially different characteristics of patients who did and did not receive podiatric care. The sample included 27 545 patients aged greater than 65+ years (Medicare‐eligible patients with employer‐sponsored supplemental insurance) and 20 208 patients aged lesser than 65 years (non Medicare‐eligible commercially insured patients). Care by podiatrists in the year prior to a diabetic foot ulcer was associated with a lower hazard of lower extremity amputation, major amputation and hospitalisations in both non Medicare‐eligible commercially insured and Medicare‐eligible patient populations. Systematic differences between patients with diabetes and foot ulcer, receiving and not receiving care from podiatrists were also observed; specifically, patients with diabetes receiving care from podiatrists tend to be older and sicker.     

Clinical outcome and determinants of amputation in a large cohort of Iranian patients with diabetic foot ulcers

ObjectiveDetermining the predictive factors of diabetes foot ulcer (DFU) development and lower extremity amputations (LEA) in patients with diabetes mellitus (DM) is of great importance to compose risk stratification models. The aim of this study is to investigate the outcome and predictors of LEA in patients with DFU in large sample of Iranian patients.MethodsThis prospective cohort study was conducted during a 2-year period from 2014 to 2016, in Shiraz, southern Iran. All the patients with type 1 and 2 DM and DFU were included in the cohort and were followed for 2 years at least. They were visited in the clinic on a monthly basis and development of new DFU and LEA were recorded. The two-year free-DFU survival and predictors of the DFU development and LEA were recorded. Multivariate regression models were used to determine the factors.ResultsA total number of 432 patients with mean age of 56.8 ± 13.3 years were included. The two-year DFU-free survival rate was 0.826. The two-year DFU-free survival was associated with male gender (p = 0.005), foot deformity (p = 0.002), history of prior DFU (p < 0.001), cigarette smoking (p = 0.032), nephropathy (p = 0.005), retinopathy (p = 0.007), ischemic heart disease (p = 0.043), and neuropathy (p < 0.001).ConclusionDevelopment of new DFU is associated with higher age, longer duration of disease, and type I diabetes. LEA was associated with increased white blood cell (WBC), Creatinine and ulcer history for major amputation and ulcer history, fasting blood sugar (FBS), infection, revascularization history, and foot deformity, for minor amputation.     

糖尿病足截肢技术进展

目的总结各种糖尿病足截肢技术的研究进展。方法查阅近年关于糖尿病足截肢技术的文献,进行综合分析。结果根据截肢平面的不同,糖尿病足的截肢技术可分为小范围截肢术和大范围截肢术两种,并衍生出多种截肢方法,截肢方式与方法的选择需要综合各种因素考虑。结论 对于糖尿病足截肢,应在保证截肢效果的前提下,尽可能降低截肢平面。患者的身体状况、糖尿病足累及的部位、组织的血流灌注情况、局部组织对感染的易感性、创口的愈合能力等是影响选择糖尿病足截肢方式和方法的重要因素。截肢后仍要重视糖尿病的综合治疗,防止截肢平面的进一步上升。