Efficacy of at home monitoring of foot temperature for risk reduction of diabetes-related foot ulcer: A meta-analysis

Aims: To perform an updated systematic review of randomised controlled trials examining the efficacy of at-home foot temperature monitoring in reducing the risk of a diabetes-related foot ulcer (DFU). Methods: Systematic review performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Risk-of-bias was assessed using version 2 of the Cochrane risk-of-bias tool. Meta-analyses were performed using random effect models. Leave-one-out sensitivity analyses and a sub-analysis excluding trials considered at high risk-of-bias assessed the consistency of the findings. The certainty of the evidence was assessed with GRADE. Results: Five randomised controlled trials involving 772 participants meeting the International Working Group on the Diabetic Foot (IWGDF) risk category 2 or 3 were included. All trials reported instructing participants to measure skin temperature at-home at six or more sites on each foot using a hand-held infra-red thermometer at least daily and reduce ambulatory activity in response to hotspots (temperature differences >2.2°C on two consecutive days between similar locations in both feet). One, one, and three trials were considered at low, moderate and high risk-of-bias, respectively. Participants allocated to at-home foot temperature monitoring had a reduced risk of developing a DFU (relative risk 0.51, 95% CI 0.31–0.84) compared to controls. Sensitivity and sub-analyses suggested that the significance of this finding was consistent. The GRADE assessment suggested a low degree of certainty in the finding. Conclusions: At-home daily foot temperature monitoring and reduction of ambulatory activity in response to hotspots reduce the risk of a DFU in moderate or high risk people with a low level of certainty

A Systematic Review and Meta-Analysis of the Incidence and Risk Factors for Re-admission to Hospital in People with Diabetes-Related Foot Disease

Objective: The aim of this study was to systematically review the incidence and risk factors for 30 day re-admission to hospital following an index admission to treat diabetes related foot disease (DFD). Data sources: A literature search was conducted using Medline/PubMed, Scopus, Cochrane Library, and CINAHL databases. Methods: The study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Studies that reported the rate of total or DFD related 30 day re-admissions were included. Meta-analysis was performed using a random effects model to calculate the pooled mean (95% confidence interval [CI]) of the proportion of patients re-admitted to hospital within 30 days. Meta-regression was performed to determine the association between risk factors and 30 day re-admission. Results: Sixteen retrospective studies with a total of 124 683 participants were included. The mean total 30 day re-admission rate was 22.0% (95% CI 17.0 – 27.0%) while the mean DFD related 30 day re-admission rate was 10.0% (95% CI 7.0 – 15.0%). Meta-regression found that greater prevalence of peripheral neuropathy (p = .045) was associated with a higher rate of any 30 day re-admission, and male sex (p = .023) and private health insurance (p = .048) were associated with lower rates of any 30 day re-admission. Coronary artery disease (p= .025) was associated with a higher rate of DFD related re-admission. All studies had low or moderate risk of bias. Conclusion: This systematic review suggested that about one fifth of patients with DFD are re-admitted to hospital within 30 days, of which about half are to treat DFD. Risk factors for re-admission included female gender, peripheral neuropathy, lack of private health insurance, and coronary artery disease.</p

Meta-analyses of randomized controlled trials reporting the effect of home foot temperature monitoring, patient education or offloading footwear on the incidence of diabetes-related foot ulcers

Aim: The aim of this study was to perform an up‐to‐date systematic review and meta‐analysis of randomized controlled trials (RCTs) examining the efficacy of home foot temperature monitoring, patient education and offloading footwear in reducing the incidence of diabetes‐related foot ulcers.Methods: A literature search was performed using MEDLINE, PubMed, CINAHL, Scopus and Cochrane databases to identify relevant original studies. Meta‐analyses were performed using intention‐to‐treat principals for worst (main analysis) and best (sub‐analysis) case scenarios. Leave‐one‐out sensitivity analyses were used to assess the consistency of findings.Results: Of 7575 unique records, 17 RCTs involving 2729 participants were included. Four tested home foot temperature monitoring (n = 468), six examined patient education (n = 823) and seven assessed offloading footwear (n = 1438). Participants’ who performed home foot temperature monitoring [odds ratio (OR) 0.51, 95% confidence interval (CI) 0.31 to 0.84; n = 468] and those provided offloading footwear (OR 0.48, 95% CI 0.29 to 0.80; n = 1438) were less likely to develop a diabetes‐related foot ulcer. Patient education programmes did not significantly reduce diabetes‐related foot ulcer incidence (OR 0.59, 95% CI 0.29 to 1.20; n = 823). Sensitivity analyses suggested that offloading footwear findings were consistent, but home foot temperature findings were dependent on the individual inclusion of one trial. All RCTs had either high or unclear risk of bias.Conclusion: This meta‐analysis suggests that offloading footwear is effective in reducing the incidence of diabetes‐related foot ulcers. Home foot temperature monitoring also appears beneficial but larger trials are needed (PROSPERO registration no.: CRD42019135226)

Repeatability, completion time, and predictive ability of four diabetes-related foot ulcer classification systems

Introduction: The inter and intra-observer reproducibility of measuring the Wound Ischemia foot Infection (WIfI) score is unknown. The aims of this study were to compare the reproducibility, completion times and ability to predict 30-day amputation of the WIfI, University of Texas Wound Classification System (UTWCS), Site, Ischemia, Neuropathy, Bacterial Infection and Depth (SINBAD) and Wagner classifications systems using photographs of diabetes-related foot ulcers. Methods: Three trained observers independently scored the diabetes-related foot ulcers of 45 participants on two separate occasions using photographs. The inter- and intra-observer reproducibility were calculated using Krippendorff's α. The completion times were compared with Kruskal-Wallis and Dunn's post-hoc tests. The ability of the scores to predict 30-day amputation rates were assessed using receiver operator characteristic curves and area under the curves. Results: There was excellent intra-observer agreement (α >0.900) and substantial agreement between observers (α=0.788) in WIfI scoring. There was moderate, substantial, or excellent agreement within the three observers (α>0.599 in all instances except one) and fair or moderate agreement between observers (α of UTWCS=0.306, α of SINBAD=0.516, α of Wagner=0.374) for the other three classification systems. The WIfI score took significantly longer (P.05 in all instances). Conclusion: The WIfI score can be completed with substantial agreement between trained observers but was not predictive of 30-day amputation

Remotely delivered monitoring and management of diabetes-related foot disease: an overview of systematic reviews

Background: Diabetes-related foot disease (DFD) management requires input from multiple healthcare professionals, and has worse outcomes for people living in remote localities by comparison to urban areas. Remotely delivered healthcare may reduce this disparity. This overview summarizes current evidence on the effectiveness, stakeholder perceptions, and cost-effectiveness of remotely delivered healthcare for DFD. Methods: A search of 5 databases was conducted to identify systematic reviews published between January 2000 and June 2020. Eligible reviews were those evaluating remotely delivered monitoring or management of patients at risk of or with active DFD, or clinicians managing these patients. Risk of bias was assessed using the AMSTAR-2 tool. Results: Eight reviews were eligible for inclusion, including 88 primary studies and 8509 participants, of which 36 studies involving 4357 participants evaluated remotely delivered monitoring or management of DFD. Only one review had a low risk of bias, with most reviews demonstrating limited search strategies and poor reporting of participants. Evidence on effectiveness was mixed, with meta-analyses demonstrating long-term ulcer healing and mortality were not significantly different between telehealth and standard care groups, although the lower-limb amputation rate was significantly decreased in one meta-analysis. Perceptions of telehealth by patients and clinicians were generally positive, whilst acknowledging limitations relating to access and use. Cost-effectiveness data were limited, with poor reporting preventing clear conclusions. Conclusions: Remotely delivered healthcare of DFD is well received by patients and clinicians, but its effectiveness is unclear. High quality trials are needed to evaluate the risks and benefits of remotely delivered DFD management

Efficacy of at home monitoring of foot temperature for risk reduction of diabetes-related foot ulcer: A meta-analysis

Aims: To perform an updated systematic review of randomised controlled trialsexamining the efficacy of at‐home foot temperature monitoring in reducing the risk of a diabetes‐related foot ulcer (DFU).Methods: Systematic review performed according to Preferred Reporting Items for Systematic reviews and Meta‐Analyses guidelines. Risk‐of‐bias was assessed using version 2 of the Cochrane risk‐of‐bias tool. Meta‐analyses were performed using random effect models. Leave‐one‐out sensitivity analyses and a sub‐analysis excluding trials considered at high risk‐of‐bias assessed the consistency of the findings. The certainty of the evidence was assessed with GRADE.Results: Five randomised controlled trials involving 772 participants meeting theInternational Working Group on the Diabetic Foot (IWGDF) risk category 2 or 3were included. All trials reported instructing participants to measure skin temperature at‐home at six or more sites on each foot using a hand‐held infra‐red thermometer at least daily and reduce ambulatory activity in response to hotspots (temperature differences >2.2°C on two consecutive days between similar locations in both feet). One, one, and three trials were considered at low, moderate and high risk‐of‐bias, respectively. Participants allocated to at‐home foot temperature monitoring had a reduced risk of developing a DFU (relative risk 0.51, 95% CI 0.31– 0.84) compared to controls. Sensitivity and sub‐analyses suggested that the significance of this finding was consistent. The GRADE assessment suggested a low degree of certainty in the finding.Conclusions: At‐home daily foot temperature monitoring and reduction of ambulatory activity in response to hotspots reduce the risk of a DFU in moderate or high risk people with a low level of certainty

Risk Factors for Hospital Re-admission for Diabetes Related Foot Disease: A Prospective Cohort Study

Objective: Diabetes related foot disease (DFD) is a common reason for admission to hospital, but the predictive factors for repeat admission are poorly defined. The primary aim of this study was to identify rates and predictive factors for DFD related hospital re-admission. Methods: Patients admitted to hospital for treatment of DFD at a single regional centre were recruited prospectively between January 2020 and December 2020. Participants were followed for 12 months to evaluate the primary outcome of hospital re-admission. The relationship between predictive factors and re-admission were examined using non-parametric statistical tests and Cox proportional hazard analyses. Results: The median age of the 190 participants was 64.9 (standard deviation 13.3) years and 68.4% were male. Forty-one participants (21.6%) identified themselves as Aboriginal or Torres Strait Islander people. One hundred participants (52.6%) were re-admitted to hospital at least once over 12 months. The commonest reason for re-admission was for treatment of foot infection (84.0% of first re-admission). Absent pedal pulses (unadjusted hazard ratio [HR] 1.90; 95% confidence interval [CI] 1.26 – 2.85), loss of protective sensation (LOPS) (unadjusted HR 1.98; 95% CI 1.08 – 3.62), and male sex (unadjusted HR 1.62; 95% CI 1.03 – 2.54) increased the risk of re-admission. After risk adjustment, only absence of pedal pulses (HR 1.92, 95% CI 1.27 – 2.91) and LOPS (HR 2.02, 95% CI 1.09 – 3.74) significantly increased the risk of re-admission. Conclusion: Over 50% of patients admitted to hospital for treatment of DFD are re-admitted within one year. Patients with absent pedal pulses and those with LOPS are twice as likely to be re-admitted.</p

Cohort Study Examining the Presentation, Distribution, and Outcomes of Peripheral Artery Disease in Aboriginal, Torres Strait Islander, and Non-Indigenous Australians

Objective: This retrospective cohort study investigated the anatomical distribution, severity, and outcome of peripheral artery disease (PAD) in Aboriginal and Torres Strait Islanders compared with non-indigenous Australians. Methods: The distribution, severity, and outcome of PAD were assessed using a validated angiographic scoring system and review of medical records in a cohort of Aboriginal and Torres Strait Islander and non-indigenous Australians. The relationship between ethnicity and PAD severity, distribution, and outcome were examined using non-parametric statistical tests, Kaplan–Meier and Cox proportional hazard analyses. Results: Seventy-three Aboriginal and Torres Strait Islanders and 242 non-indigenous Australians were included and followed for a median of 6.7 [IQR 2.7, 9.3] years. Aboriginal and Torres Strait Islander patients were more likely to present with symptoms of chronic limb threatening ischaemia (81% vs. 25%; p < .001), had greater median [IQR] angiographic scores for the symptomatic limb (7 [5, 10] vs. 4 [2, 7]) and tibial arteries (5 [2, 6] vs. 2 [0, 4]) and had higher risk of major amputation (HR 6.1, 95% CI 3.6 – 10.5; p < .001) and major adverse cardiovascular events (HR 1.5, 95% CI 1.0 – 2.3; p = .036) but not for revascularisation (HR 0.8, 95% CI 0.5 – 1.3; p = .37) compared with non-indigenous Australians. The associations with major amputation and major adverse cardiovascular events were no longer statistically significant when adjusted for limb angiographic score. Conclusion: Compared with non-indigenous patients, Aboriginal and Torres Strait Islander Australians had more severe tibial artery disease and a higher risk of major amputation and major adverse cardiovascular events.</p

Prediction of organophosphorus insecticide-induced intermediate syndrome with stimulated concentric needle single fibre electromyography

Background Deliberate self-poisoning (DSP) using organophosphorus (OP) insecticides are a common clinical problem in Asia. OPs inhibit acetylcholine esterase (AChE), leading to over-activity of muscarinic and nicotinic cholinergic circuits. Intermediate syndrome (IMS) is mediated via prolonged nicotinic receptor stimulation at the neuromuscular junction and its onset is between 24-96 hours post ingestion. The aims of the present study were 1) to investigate whether neuromuscular junction dysfunction within the first 24 hours following exposure, quantified by jitter in single fibre electromyography (SfEMG), can predict IMS, and 2) to compare the changes in SfEMG jitter over the course of the illness among patients who developed IMS (IMS+) and those who did not (IMS-). Methods and findings We conducted a prospective cohort study in a tertiary care hospital in Sri Lanka on 120 patients admitted between September 2014 and August 2016 following DSP by OP insecticides viz., profenofos 53, phenthoate 17, diazinon 13, chlorpyrifos 5, others 12, unknown 20. SfEMG was performed every second day during hospitalization. Exposure was confirmed based on the history and red blood cell AChE assays. IMS was diagnosed in patients who demonstrated at least three out of four of the standard IMS criteria: Proximal muscle weakness, bulbar muscle weakness, neck muscle weakness, respiratory paralysis between 24±96 hours post ingestion. Respiratory failure requiring intubation occurred in 73 out of 120 patients; 64 of these were clinically diagnosed with IMS. Of the 120 patients, 96 had repeated SfEMG testing, 67 of them being tested within the first 24 hours. Prolonged jitter (>33.4μs) within the first 24 hours was associated with greatly increased risk of IMS (odds ratio = 8.9, 95% confidence intervals = 2.4-29.6, p = 0.0003; sensitivity 86%, specificity 58%). The differences in jitter between IMS+ and IMS- patients remained significant for 72 hours and increased jitter was observed in some patients for up to 216 hours. For intubated patients, the median time for jitter to normalize and median time to extubate were similar, and the two variables had a moderate positive correlation (r = 0.49, P = 0.001). Conclusions Prolonged jitter recorded with SfEM