Electrochemical skin conductance to detect sudomotor dysfunction, peripheral neuropathy and the risk of foot ulceration among Saudi patients with diabetes mellitus.
ABSTRACT: Sudomotor dysfunction is manifested clinically as abnormal sweating leading to dryness of feet skin and increased risk of foot ulceration. The aim of this study was to test the performance of foot electrochemical skin conductance (ESC) to detect diabetic peripheral neuropathy and the risk of foot ulceration against traditional methods in Saudi patients with diabetes mellitus.This cross-sectional study was conducted on 296 Saudi patients with diabetes mellitus. Painful neuropathic symptoms were evaluated using the neuropathy symptom score (NSS). The risk of foot ulceration and diabetic peripheral neuropathy were determined using the neuropathy disability score (NDS). Vibration perception threshold (VPT) was assessed using neurothesiometer. Neurophysiological assessment of the right and left sural, peroneal and tibial nerves was performed in 222 participants. Diabetic peripheral neuropathy was defined according to the definition of the American Academy of Neurology. ESC was measured with Sudoscan.Feet-ESC decreased as the scores of sensory and motor function tests increased. Feet-ESC decreased as the NSS, NDS and severity of diabetic peripheral neuropathy increased. Sensitivity of feet-ESC < 50μS to detect diabetic peripheral neuropathy assessed by VPT ≥ 25 V, NDS ≥ 3, NDS ≥ 6 was 90.1, 61 and 63.8 % respectively and specificity 77, 85 and 81.9 % respectively. Sensitivity of feet-ESC < 70μS to detect diabetic peripheral neuropathy assessed by VPT ≥ 25 V, NDS ≥ 3, NDS ≥ 6 was 100, 80.6 and 80.9 % respectively. Sensitivity and specificity of feet-ESC < 70μS to detect confirmed-diabetic peripheral neuropathy were 67.5 and 58.9 % respectively.Sudoscan a simple and objective tool can be used to detect diabetic peripheral neuropathy and the risk of foot ulceration among patients with diabetes mellitus. Prospective studies to confirm our results are warranted.
Project description:The early diagnosis of diabetic peripheral neuropathy (DPN) is challenging. Sudomotor dysfunction is one of the earliest detectable abnormalities in DPN. The present study aimed to determine the diagnostic performance of the electrochemical skin conductance (ESC) test in detecting early DPN, compared with the vibration perception threshold (VPT) test and diabetic neuropathy symptom (DNS) score, using the modified neuropathy disability score (NDS) as the reference standard. Five hundred and twenty-three patients with type 2 diabetes underwent an NDS-based clinical assessment for neuropathy. Participants were classified into the DPN and non-DPN groups based on the NDS (? 6). Both groups were evaluated further using the DNS, and VPT and ESC testing. A receiver-operator characteristic (ROC) curve analysis was performed to compare the efficacy of ESC measurements with those of DNS and VPT testing in detecting DPN. The DPN group (n = 110, 21%) had significantly higher HbA1c levels and longer diabetes durations compared with the non-DPN group (n = 413). The sensitivity of feet ESC < 60 ?S, VPT testing, and DNS in detecting DPN were 85%, 72%, and 52%, respectively. The specificity of feet ESC, VPT, and DNS in detecting DPN were 85%, 90% and 60% respectively. The areas under the curves of the ROC plots for feet ESC, VPT testing, and DNS were 0.88, 0.84, and 0.6, respectively. A significant inverse linear relationship was noted between VPT and feet ESC (r = -0.45, p = <0.0001). The odds ratios for having DPN, based on the mean feet ESC testing < 60 ?S, VPT testing > 15 V, and DNS ? 1, were 16.4, 10.9 and 1.8, respectively. ESC measurement is an objective and sensitive technique for the early detection of DPN. Feet ESC measurement was superior to VPT testing for identifying patients with early DPN.
Project description:Research Question: Previous cross-sectional studies have shown an association between sudomotor dysfunction and diabetic foot ulceration (DFU). The aim of this prospective multicenter study was to determine the role of dryness of foot skin and of established neurological modalities in the prediction of risk for foot ulceration in a cohort of individuals with diabetes mellitus (DM). Design: The study was conducted from 2012 to 2017. A total of 308 subjects with DM without history of DFU or critical limb ischemia completed the study. Diabetic neuropathy was assessed using the neuropathy symptom score (NSS) and neuropathy disability score (NDS). In a subset of participants, vibration perception threshold (VPT) was evaluated. Dryness of foot skin was assessed by the visual indicator plaster method (IPM). The diagnostic performance of the above neurological modalities for prediction of DFU was tested by receiver operating characteristic curve (ROC) analysis. Results: During the 6-year follow-up, 55 patients (annual ulceration incidence 2.97%) developed DFU. Multivariate Cox-regression analysis after controlling for the effect of age, gender, and DM duration demonstrated that the risk (hazard ratio, 95% confidence intervals) of DFU increased significantly with either abnormal IPM (3.319, 1.460-7.545, p = 0.004) or high (?6) NDS (2.782, 1.546-5.007, p = 0.001) or high (?25 volts) VPT (2.587, 1.277-5.242, p = 0.008). ROC analysis showed that all neurological modalities could discriminate participants who developed DFU (p < 0.001). IPM testing showed high sensitivity (0.86) and low specificity (0.49), while high vs. low NDS and VPT showed low sensitivity (0.40 and 0.39, respectively) and high specificity (0.87 and 0.89, respectively) for identification of patients at risk for DFU. Conclusion: Dryness of foot skin assessed by the IPM predicts the development of DFU. IPM testing has high sensitivity, whereas high NDS and VPT have high specificity in identifying subjects at risk for DFU. The IPM can be included in the screening methods for identification of the foot at risk.
Project description:Bilirubin is an antioxidant and plays a protective role against cardiovascular and microvascular disease. The aim of this study is to explore the possible protective effect of bilirubin on small nerve function. A total of 265 Chinese patients with type 2 diabetes mellitus (T2DM) were enrolled in the study. Both SUDOSCAN and other traditional diabetic neuropathy examinations including neuropathy symptom score (NSS), the neuropathy disability score (NDS) and Michigan Neuropathy Screening Instrument (MNSI) scores were performed in all patients with T2DM. Blood bilirubin levels were tested in the study. Spearman correlation analysis and multivariate regression analysis were performed to determine the relation between bilirubin level and hands and feet ESC values. Spearman correlation analysis demonstrated a correlation between total bilirubin and ESC levels including hands (r = 0.165, P < 0.05) and feet (r = 0.122, P < 0.05) as well as between UCBil and ESC levels including both hands (r = 0.172, P < 0.05) and feet (r = 0.175, P < 0.05). Multivariate regression linear analyses showed both total bilirubin and UCBil level were independently associated with hands and feet ESC levels. All these results suggested a positive association between bilirubin level and ESC level, indicating a possible protective role of bilirubin in peripheral small nerve dysfunction of type 2 diabetes mellitus.
Project description:OBJECTIVE:Diabetic large-nerve fiber dysfunction, as measured by vibration perception threshold (VPT), predicts foot ulceration, amputation, and mortality. Thus, determination of modifiable risk factors is of great clinical importance. RESEARCH DESIGN AND METHODS:We assessed 1,407 patients with type 1 diabetes and a normal VPT participating in the EURODIAB Prospective Complications Study, at baseline mean +/- SD age of 32.7 +/- 10.2 years with diabetes duration of 14.7 +/- 9.3 years and follow-up of 7.3 +/- 0.6 years. VPT was measured using biothesiometry on the right big toe and medial malleolus. An abnormal result was defined as >2 SD from the predicted mean for the patient s age. RESULTS:An abnormal VPT was associated with an increased incidence of gangrene, amputation, foot ulceration, leg bypass or angioplasty, and mortality (P < OR = 0.02). The incidence of abnormal VPT was 24% over the 7.3-year follow-up. Duration of diabetes and A1C significantly influenced the incidence of abnormal VPT (P < 0.0001). After correction for these, established risk factors for cardiovascular disease (CVD), including male sex (P = 0.0004), hypertension (P < 0.0001), total cholesterol (P = 0.002), LDL cholesterol (P = 0.01), smoking (P < 0.0001), weight (P < 0.0001), and diabetes complications (retinopathy [P = 0.0001], nephropathy [P = 0.01], and autonomic neuropathy [P = 0.001]), were all found to be significant risk factors. A previous history of CVD doubled the incidence of abnormal VPT. CONCLUSIONS:This prospective study indicates that cardiovascular risk factors predict development of large-fiber dysfunction, which may account for the high mortality rate in patients with an abnormal VPT, and emphasizes the importance of early determination of VPT to detect subclinical neuropathy and to address cardiovascular risk factors.
Project description:AIMS: Elevated dynamic plantar pressures are a consistent finding in diabetes patients with peripheral neuropathy with implications for plantar foot ulceration. This meta-analysis aimed to compare the plantar pressures of diabetes patients that had peripheral neuropathy and those with neuropathy with active or previous foot ulcers. METHODS: Published articles were identified from Medline via OVID, CINAHL, SCOPUS, INFORMIT, Cochrane Central EMBASE via OVID and Web of Science via ISI Web of Knowledge bibliographic databases. Observational studies reporting barefoot dynamic plantar pressure in adults with diabetic peripheral neuropathy, where at least one group had a history of plantar foot ulcers were included. Interventional studies, shod plantar pressure studies and studies not published in English were excluded. Overall mean peak plantar pressure (MPP) and pressure time integral (PTI) were primary outcomes. The six secondary outcomes were MPP and PTI at the rear foot, mid foot and fore foot. The protocol of the meta-analysis was published with PROPSERO, (registration number CRD42013004310). RESULTS: Eight observational studies were included. Overall MPP and PTI were greater in diabetic peripheral neuropathy patients with foot ulceration compared to those without ulceration (standardised mean difference 0.551, 95% CI 0.290-0.811, p<0.001; and 0.762, 95% CI 0.303-1.221, p = 0.001, respectively). Sub-group analyses demonstrated no significant difference in MPP for those with neuropathy with active ulceration compared to those without ulcers. A significant difference in MPP was found for those with neuropathy with a past history of ulceration compared to those without ulcers; (0.467, 95% CI 0.181- 0.753, p = 0.001). Statistical heterogeneity between studies was moderate. CONCLUSIONS: Plantar pressures appear to be significantly higher in patients with diabetic peripheral neuropathy with a history of foot ulceration compared to those with diabetic neuropathy without a history of ulceration. More homogenous data is needed to confirm these findings.
Project description:High plantar pressures have been associated with foot ulceration in people with diabetes, who can experience loss of protective sensation due to peripheral neuropathy. Therefore, characterization of elevated plantar pressure distributions can provide a means of identifying diabetic patients at potential risk of foot ulceration. Plantar pressure distribution classification can also be used to determine suitable preventive interventions, such as the provision of an appropriately designed insole. In the past, emphasis has primarily been placed on the identification of individual focal areas of elevated pressure. The goal of this study was to utilize k-means clustering analysis to identify typical regional peak plantar pressure distributions in a group of 819 diabetic feet. The number of clusters was varied from 2 to 10 to examine the effect on the differentiation and classification of regional peak plantar pressure distributions. As the number of groups increased, so too did the specificity of their pressure distributions: starting with overall low or overall high peak pressure groups and extending to clusters exhibiting several focal peak pressures in different regions of the foot. However, as the number of clusters increased, the ability to accurately classify a given regional peak plantar pressure distribution decreased. The balance between these opposing constraints can be adjusted when assessing patients with feet that are potentially "at risk" or while prescribing footwear to reduce high regional pressures. This analysis provides an understanding of the variability of the regional peak plantar pressure distributions seen within the diabetic population and serves as a guide for the preemptive assessment and prevention of diabetic foot ulcers.
Project description:Background:Diabetic foot ulceration is a devastating complication of diabetes mellitus and is a major source of morbidity and mortality. So far, there are few published data on diabetic foot ulcers and its determinants among diabetic patients on follow-up at Jimma Medical Center. Hence, the aim of this study was to assess the prevalence of diabetic foot ulcer and its determinants among patients with diabetes mellitus at Jimma Medical Center. Methods:A hospital-based cross-sectional study was conducted from June 1 to August 30, 2019, and systematic random sampling technique was applied. The total number of study subjects who participated in the study was 277. Data were collected using an interview-administered structured questionnaire. Data were entered into EpiData version 3.1 and exported to SPSS version 20 software for analysis. Analysis was done using descriptive statistics and logistic regression. A variable having a p value of <0.25 in the bivariate model was subjected to multivariate analysis to avoid confounding the variable's effect. Adjusted odds ratios (AOR) were calculated at 95% confidence interval and considered significant with a p value of <0.25 in the bivariate model was subjected to multivariate analysis to avoid confounding the variable's effect. Adjusted odds ratios (AOR) were calculated at 95% confidence interval and considered significant with a. Result:The mean of age of participants was 50.1 ± 14.19 years. More than three-fourths of participants (82.7%) were type 2 DM. The mean duration of diabetic patients was 6.00 ± 5.07 years. The prevalence of diabetic foot ulcer was 11.6% among study participants. According to multivariate logistic regression analysis, previous history of ulceration (AOR = 5.77; 95% CI: 2.37, 14.0) and peripheral neuropathy (AOR = 11.2; 95% CI: 2.8, 44.4) were independent predictors of diabetic foot ulcer. Conclusion:The prevalence of diabetic foot ulcer was 11.6%. Previous history of ulceration and peripheral neuropathy were associated with diabetic foot ulcer. The health care providers are recommended to thoroughly give emphasis during follow-up of patients who had previous history of ulceration and peripheral neuropathy in order to decrease the occurrence of diabetic foot ulcer.
Project description:<h4>Background</h4>Charcot neuropathic osteoarthropathy associated foot deformity can result in joint instability, ulceration, and even amputation. The purpose of the present study was to follow patients with and without active Charcot osteoarthropathy for as long as two years to examine the magnitude and timing of foot alignment changes.<h4>Methods</h4>We studied fifteen subjects with Charcot osteoarthropathy and nineteen subjects with diabetes mellitus and peripheral neuropathy without Charcot osteoarthropathy for one year; eight of the subjects with osteoarthropathy and five of the subjects with diabetes and peripheral neuropathy were followed for two years. Bilateral weight-bearing radiographs of the foot were made at baseline for all subjects, with repeat radiographs being made at six months for the osteoarthropathy group and at one and two years for both groups. Radiographic measurements included the Meary angle, cuboid height, calcaneal pitch, and hindfoot-forefoot angle.<h4>Results</h4>The Meary angle, cuboid height, and calcaneal pitch worsened in feet with Charcot osteoarthropathy over one year as compared with the contralateral, uninvolved feet and feet in patients with diabetes and peripheral neuropathy. Cuboid height continued to worsen over the two-year follow-up in the feet with Charcot osteoarthropathy. These feet also had a greater change in the hindfoot-forefoot angle at one year as compared with the feet in patients with diabetes and peripheral neuropathy and at two years as compared with the contralateral, uninvolved feet.<h4>Conclusions</h4>In patients with Charcot neuropathic osteoarthropathy, radiographic alignment measurements demonstrate the presence of foot deformity at the time of the initial clinical presentation and evidence of progressive changes over the first and second years. The six-month data suggest worsening of medial column alignment prior to lateral column worsening. This radiographic evidence of worsening foot alignment over time supports the need for aggressive intervention (conservative bracing or surgical fixation) to attempt to prevent limb-threatening complications.
Project description:Elevated dynamic plantar foot pressures significantly increase the risk of foot ulceration in diabetes mellitus. The aim was to determine which factors predict plantar pressures in a population of diabetic patients who are at high-risk of foot ulceration.Patients with diabetes, peripheral neuropathy and a history of ulceration were eligible for inclusion in this cross sectional study. Demographic data, foot structure and function, and disease-related factors were recorded and used as potential predictor variables in the analyses. Barefoot peak pressures during walking were calculated for the heel, midfoot, forefoot, lesser toes, and hallux regions. Potential predictors were investigated using multivariate linear regression analyses. 167 participants with mean age of 63 years contributed 329 feet to the analyses.The regression models were able to predict between 6% (heel) and 41% (midfoot) of the variation in peak plantar pressures. The largest contributing factor in the heel model was glycosylated haemoglobin concentration, in the midfoot Charcot deformity, in the forefoot prominent metatarsal heads, in the lesser toes hammer toe deformity and in the hallux previous ulceration. Variables with local effects (e.g. foot deformity) were stronger predictors of plantar pressure than global features (e.g. body mass, age, gender, or diabetes duration).The presence of local deformity was the largest contributing factor to barefoot dynamic plantar pressure in high-risk diabetic patients and should therefore be adequately managed to reduce plantar pressure and ulcer risk. However, a significant amount of variance is unexplained by the models, which advocates the quantitative measurement of plantar pressures in the clinical risk assessment of the patient.
Project description:OBJECTIVE: Sudomotor dysfunction may be an early detectable abnormality in diabetic small fiber neuropathy. The aim of this study was to evaluate the efficacy of Sudoscan™ (Impeto Medical, Paris, France) in detecting diabetic neuropathy (DN), in comparison with other standardized tests, in patients with diabetes mellitus (DM). SUBJECTS AND METHODS: Sudoscan measures electrochemical skin conductance (ESC) of hands and feet through reverse iontophoresis. We evaluated 83 DM patients with and without DN and 210 healthy controls (HCs). Neuropathy Impairment Score-Lower Legs (NIS-LL), quantitative autonomic function testing (QAFT), and quantitative sensory testing (QST) were performed. Symptomatic pain was recorded using a visual analog scale. Receiver-operator characteristic (ROC) curves were calculated to evaluate the efficacy of Sudoscan in detecting DN compared with traditional modalities. RESULTS: Diabetes patients with DN had significantly worse ESCs of feet and hands than DM patients without DN and HCs (respectively, 56.3±3 vs. 75.9±5.5 and 84.4±0.9 [P<0.0001] for feet and 51.9±2.4 vs. 67.5±4.3 and 73.1±0.8 [P<0.0001] for hands). Increasing NIS-LL scores were associated with decreasing ESC values. ESCs correlated significantly with clinical (NIS-LL), somatic (QST), and autonomic (QAFT) measures of neuropathy and with pain scores. ROC curve analysis showed significant results for both hands and feet ESC (area under the curve of 0.86 and 0.88, respectively; P<0.0001) with sensitivity of 78% and specificity of 92% for feet to detect DN. CONCLUSIONS: Sudoscan is a promising, sensitive tool to detect neuropathy in patients with DM. This is a very simple, easy-to-perform test that can be done in the clinical setting in 3-5?min.