Infrared thermography and ulcer prevention in the high-risk diabetic foot: data from a single-blind multicentre controlled clinical trial.

AIM: To assess the usefulness of monthly thermography and standard foot care to reduce diabetic foot ulcer recurrence. METHODS: People with diabetes (n = 110), neuropathy and history of ≥ 1 foot ulcer participated in a single-blind multicentre clinical trial. Feet were imaged with a novel thermal imaging device (Diabetic Foot Ulcer Prevention System). Participants were randomized to intervention (active thermography + standard foot care) or control (blinded thermography + standard foot care) and were followed up monthly until ulcer recurrence or for 12 months. Foot thermograms of participants from the intervention group were assessed for hot spots (areas with temperature ≥ 2.2°C higher than the corresponding contralateral site) and acted upon as per local standards. RESULTS: After 12 months, 62% of participants were ulcer-free in the intervention group and 56% in the control group. The odds ratios of ulcer recurrence (intervention vs control) were 0.82 (95% CI 0.38, 1.8; P = 0.62) and 0.55 (95% CI 0.21, 1.4; P = 0.22) in univariate and multivariate logistic regression analyses, respectively. The hazard ratios for the time to ulcer recurrence (intervention vs control) were 0.84 (95% CI 0.45, 1.6; P = 0.58) and 0.67 (95% CI 0.34, 1.3; P = 0.24) in univariate and multivariate Cox regression analyses, respectively. CONCLUSIONS: Monthly intervention with thermal imaging did not result in a significant reduction in ulcer recurrence rate or increased ulcer-free survival in this cohort at high risk of foot ulcers. This trial has, however, informed the design of a refined study with longer follow-up and group stratification, further aiming to assess the efficacy of thermography to reduce ulcer recurrence.

NPL contributions to the standardisation and validation of contemporary medical thermometry methods.

Since the advent of reliable mercury-in-glass thermometers in the latter part of the 19th century the practice of clinical thermometry was thought to be a solved issue. However with advances in technology there has, in recent decades, been a proliferation of temperature measurement methods applied to medical science. Many of these have been introduced because of the clinical benefit they confer, nevertheless, in some cases the metrological foundation and infrastructure to ensure sound measurement was not in place. This paper will focus on the standardisation activity undertaken by the UK's National Physical Laboratory (NPL) to support reliable temperature measurement, using a number of innovative methods, in a clinical setting.

Reliability of a novel thermal imaging system for temperature assessment of healthy feet.

BACKGROUND: Thermal imaging is a useful modality for identifying preulcerative lesions ("hot spots") in diabetic foot patients. Despite its recognised potential, at present, there is no readily available instrument for routine podiatric assessment of patients at risk. To address this need, a novel thermal imaging system was recently developed. This paper reports the reliability of this device for temperature assessment of healthy feet. METHODS: Plantar skin foot temperatures were measured with the novel thermal imaging device (Diabetic Foot Ulcer Prevention System (DFUPS), constructed by Photometrix Imaging Ltd) and also with a hand-held infrared spot thermometer (Thermofocus® 01500A3, Tecnimed, Italy) after 20 min of barefoot resting with legs supported and extended in 105 subjects (52 males and 53 females; age range 18 to 69 years) as part of a multicentre clinical trial. The temperature differences between the right and left foot at five regions of interest (ROIs), including 1st and 4th toes, 1st, 3rd and 5th metatarsal heads were calculated. The intra-instrument agreement (three repeated measures) and the inter-instrument agreement (hand-held thermometer and thermal imaging device) were quantified using intra-class correlation coefficients (ICCs) and the 95% confidence intervals (CI). RESULTS: Both devices showed almost perfect agreement in replication by instrument. The intra-instrument ICCs for the thermal imaging device at all five ROIs ranged from 0.95 to 0.97 and the intra-instrument ICCs for the hand-held-thermometer ranged from 0.94 to 0.97. There was substantial to perfect inter-instrument agreement between the hand-held thermometer and the thermal imaging device and the ICCs at all five ROIs ranged between 0.94 and 0.97. CONCLUSIONS: This study reports the performance of a novel thermal imaging device in the assessment of foot temperatures in healthy volunteers in comparison with a hand-held infrared thermometer. The newly developed thermal imaging device showed very good agreement in repeated temperature assessments at defined ROIs as well as substantial to perfect agreement in temperature assessment with the hand-held infrared thermometer. In addition to the reported non-inferior performance in temperature assessment, the thermal imaging device holds the potential to provide an instantaneous thermal image of all sites of the feet (plantar, dorsal, lateral and medial views). TRIAL REGISTRATION: Diabetic Foot Ulcer Prevention System NCT02317835, registered December 10, 2014.

The Boltzmann project.

The International Committee for Weights and Measures (CIPM), at its meeting in October 2017, followed the recommendation of the Consultative Committee for Units (CCU) on the redefinition of the kilogram, ampere, kelvin and mole. For the redefinition of the kelvin, the Boltzmann constant will be fixed with the numerical value 1.380 649 × 10-23 J K-1. The relative standard uncertainty to be transferred to the thermodynamic temperature value of the triple point of water will be 3.7 × 10-7, corresponding to an uncertainty in temperature of 0.10 mK, sufficiently low for all practical purposes. With the redefinition of the kelvin, the broad research activities of the temperature community on the determination of the Boltzmann constant have been very successfully completed. In the following, a review of the determinations of the Boltzmann constant k, important for the new definition of the kelvin and performed in the last decade, is given.

A medical thermal imaging device for the prevention of diabetic foot ulceration.

In this paper a description is given of the development, characterisation and first results of a thermal imaging device aimed at significantly reducing the incidence of diabetic foot ulceration (DFU). These devices will be used in three clinical centres and in two preliminary clinical trials. The first will be on healthy volunteers to set a robust baseline for the overall research aims and the second on >100 patients at high risk of DFU. In the second phase of the project the objective is to demonstrate significant reduction in the incidence of DFU through a comparison of the results of standard care of high risk feet with standard care plus thermal imaging.

Dissemination of thermodynamic temperature above the freezing point of silver.

The mise-en-pratique for the definition of the kelvin at high temperatures will formally allow dissemination of thermodynamic temperature either directly or mediated through high-temperature fixed points (HTFPs). In this paper, these two distinct dissemination methods are evaluated, namely source-based and detector-based. This was achieved by performing two distinct dissemination trials: one based on HTFPs, the other based on absolutely calibrated radiation thermometers or filter radiometers. These trials involved six national metrology institutes in Europe in the frame of the European Metrology Research Programme joint project 'Implementing the new kelvin' (InK). The results have shown that both dissemination routes are possible, with similar standard uncertainties of 1-2 K, over the range 1273-2773 K, showing that, depending on the facilities available in the laboratory, it will soon be possible to disseminate thermodynamic temperatures above 1273 K to users by either of the two methods with uncertainties comparable to the current temperature scale.

Thermodynamic temperature assignment to the point of inflection of the melting curve of high-temperature fixed points.

The thermodynamic temperature of the point of inflection of the melting transition of Re-C, Pt-C and Co-C eutectics has been determined to be 2747.84 ± 0.35 K, 2011.43 ± 0.18 K and 1597.39 ± 0.13 K, respectively, and the thermodynamic temperature of the freezing transition of Cu has been determined to be 1357.80 ± 0.08 K, where the ± symbol represents 95% coverage. These results are the best consensus estimates obtained from measurements made using various spectroradiometric primary thermometry techniques by nine different national metrology institutes. The good agreement between the institutes suggests that spectroradiometric thermometry techniques are sufficiently mature (at least in those institutes) to allow the direct realization of thermodynamic temperature above 1234 K (rather than the use of a temperature scale) and that metal-carbon eutectics can be used as high-temperature fixed points for thermodynamic temperature dissemination. The results directly support the developing mise en pratique for the definition of the kelvin to include direct measurement of thermodynamic temperature.

The kelvin redefinition and its mise en pratique.

In 2018, it is expected that there will be a major revision of the International System of Units (SI) which will result in all of the seven base units being defined by fixing the values of certain atomic or fundamental constants. As part of this revision, the kelvin, unit of thermodynamic temperature, will be redefined by assigning a value to the Boltzmann constant k. This explicit-constant definition will define the kelvin in terms of the SI derived unit of energy, the joule. It is sufficiently wide to encompass any form of thermometry. The planned redefinition has motivated the creation of an extended mise en pratique ('practical realization') of the definition of the kelvin (MeP-K), which describes how the new definition can be put into practice. The MeP-K incorporates both of the defined International Temperature Scales (ITS-90 and PLTS-2000) in current use and approved primary-thermometry methods for determining thermodynamic temperature values. The MeP-K is a guide that provides or makes reference to the information needed to perform measurements of temperature in accord with the SI at the highest level. In this article, the background and the content of the extended second version of the MeP-K are presented.

Estimates of the difference between thermodynamic temperature and the International Temperature Scale of 1990 in the range 118 K to 303 K.

Using exceptionally accurate measurements of the speed of sound in argon, we have made estimates of the difference between thermodynamic temperature, T, and the temperature estimated using the International Temperature Scale of 1990, T90, in the range 118 K to 303 K. Thermodynamic temperature was estimated using the technique of relative primary acoustic thermometry in the NPL-Cranfield combined microwave and acoustic resonator. Our values of (T-T90) agree well with most recent estimates, but because we have taken data at closely spaced temperature intervals, the data reveal previously unseen detail. Most strikingly, we see undulations in (T-T90) below 273.16 K, and the discontinuity in the slope of (T-T90) at 273.16 K appears to have the opposite sign to that previously reported.

Umbilical cord diameter percentile curves and their correlation to birth weight and placental pathology.

OBJECTIVE: The aims of this study were to develop a nomogram of umbilical cord diameter (UCD) for pathologic examination of the placenta, to identify the umbilical cord components responsible for variations in UCD, and to examine the relationship between UCD and other placental pathologic features and perinatal outcome. STUDY DESIGN: We prospectively collected 497 umbilical cords between 18 and 41 weeks' gestation over a 1-year period. Fresh-tissue UCD were grouped according to gestational age and compared to sonographic and histological measurements. Associations between UCD percentile and placental pathologic findings or obstetrical outcomes were examined. RESULTS: Mean UCD increased with gestational age until a plateau at 1.0 cm in the third trimester, a value that was 0.56 cm less than sonographic measurements prior to delivery and 0.17 cm greater than UCD measured histologically. Umbilical cord components varied with UCD percentile, with umbilical vessel area increased in thick cords (p < 0.001) and Wharton's jelly area reduced in thin cords (p = 0.002). Thin umbilical cords were associated with at least one pathologic histological placental finding (p = 0.02), low placental weight (p < 0.001), single umbilical artery (p = 0.02), marginal cord insertion (p = 0.01), and low infant birth weight (p < 0.001). CONCLUSIONS: This study provides reference curves for post-delivery UCD from 18 to 41 weeks' gestation for use by perinatal pathologists. We show that increased UCD is a function of increased umbilical blood vessel volume and decreased UCD is a function of decreased Wharton's jelly volume. UCD shows a strong association with placental and infant birth weight.

High-precision calibration of MRS thermometry using validated temperature standards: effects of ionic strength and protein content on the calibration.

Currently, there is very limited ability to measure the temperature of the brain, but a direct technique for its estimation in vivo could improve the detection of patients at risk of temperature-related brain damage, help in the diagnosis of stroke and tumour, and provide useful information on the mechanisms of thermoregulation of the brain. In this article, new calibrations in vitro of MRS thermometry using temperature-stabilised reference phantoms are reported. The phantoms comprise two concentric glass spheres: the inner sphere contains the phantom material to be measured by MRS, and the outer sphere contains a substance with a known temperature stable to within 0.2 °C. The substances were freezing organic fixed-point compounds (diphenyl ether and ethylene carbonate, freezing at 26.3 and 35.8 °C, respectively) or temperature-controlled circulating water. The phantom temperature was continuously monitored with a fluoroptic probe calibrated at the National Physical Laboratory with traceability to the International Temperature Scale 1990 (ITS-90). The MRS temperature calibration was obtained by measuring the chemical shift of water relative to N-acetylaspartate (NAA) in a single voxel as a function of temperature using a 1.5-T Philips Intera scanner. Measurements were made for several phantom materials to assess the effect of tissue composition on the water-NAA chemical shift against temperature calibration. The phantom mixtures contained 25 mm of NAA buffered to pH 6.5 or 7.5 and several ionic salts or bovine serum albumin (BSA). Spectra were acquired from 25 to 45 °C. The correlation between frequency differences and phantom temperature was very linear with small residuals. However, the linear fitting parameters varied with ionic composition and BSA concentration. The 'apparent' temperature (calibrated using the water-NAA frequency differences) decreased by approximately 1 °C for every 100 mm increase in ionic concentration and increased proportionally to the concentration of BSA.

Congenital heart defects in a large, unselected cohort of monochorionic twins.

OBJECTIVE: To determine the prevalence of congenital heart defects (CHDs) in a large, unselected cohort of monochorionic (MC) twins. STUDY DESIGN: We completed a chart review of all MC twin pregnancies in the Kaiser Permanente Northern California population from 1996 to 2003. CHDs were identified by diagnostic codes and confirmed by postnatal echocardiograms. Follow-up was obtained through one year of age. RESULT: A total of 926 liveborn MC twins met inclusion criteria. The prevalence of CHDs was 7.5%, 11.6 times the general population rate (CI 9.2 to 14.5). Septal defects were most common. 20% of infants with heart defects had twin-to-twin transfusion syndrome (TTTS) versus 8% of infants without defects (P<0.01); this association remained significant when controlling for potential confounders. CONCLUSION: The prevalence of CHDs in this large cohort of MC twins was significantly higher than the general population rate, with TTTS an added risk factor.

Environmental isolation and characterisation of Cryptococcus species from living trees in Havana city, Cuba.

Cryptococcus isolates from Cuban patients were identified as C. neoformans var. grubii. Although this species has since long been associated with bird droppings, a recent genotyping study provided strong evidence for additional origins of exposure. We sampled different species of trees in Havana, Cuba to identify other potential sources of exposure to this fungus. A total of 662 samples were collected from 331 trees and cacti from Havana, Cuba. Initial selection of the isolates was carried out by conventional techniques. Isolates were further characterised using a combination of AFLP analysis and DNA sequence analysis. Identification by conventional methods yielded 121 C. neoformans and 61 C. gattii isolates. Molecular analyses showed that none of these isolates was C. gattii and only one isolate proved to be C. neoformans var. grubii. A total of 27 different other species were identified. The most prevalent species was C. heveanensis (33%). Sixty-five unidentifiable isolates segregated into ten potentially novel species. Conventional cultivation methods have a low specificity for C. neoformans complex and molecular analyses need to be applied to confirm identification of isolates from environmental sources. Environmental niches responsible for most of human cryptococcal infections in Cuba remain to be identified.

New standards for devices used for the measurement of human body temperature.

Significant changes in recording of human body temperature have been taking place worldwide in recent years. The clinical thermometer introduced in the mid-19th century by Wunderlich has been replaced by digital thermometers or radiometer devices for recording tympanic membrane temperature. More recently the use of infrared thermal imaging for fever screening has become more widespread following the SARS infection, and particularly during the pandemic H1N1 outbreak. Important new standards that have now reached international acceptance will affect clinical and fever screening applications. This paper draws attention to these new standard documents. They are designed to improve the standardization of both performance and practical use of these key techniques in clinical medicine, especially necessary in a pandemic influenza situation.

A systematic performance evaluation of brain and body temperature sensors using ultra-stable temperature references.

The impact of a rise in the temperature of the human brain in patients who have suffered cerebral damage is not completely understood. Current studies are ambiguous; some show that a high brain temperature, and others a low brain temperature, is an indicator of poor prognosis. The reported effect is often very subtle, at the <0.5 degrees C level, and this may be due to the performance, or even the location of the temperature sensor. This study investigates the first of these issues, i.e. the performance of the sensor. Here performance validation is undertaken for three commonly used temperature sensors for brain and body temperature measurement, using ultra-stable temperature references. At body temperature all three sensor types performed within manufacturer's specifications. Given that only a small number of temperature sensors were tested, the indication is that, provided the sensors are located correctly, the small observed differences in temperature are real - though the issue of clinical significance is still to be addressed.

Traceability and calibration in temperature measurement: a clinical necessity.

Patient temperature is a fundamental physiological measurement used primarily for observation and diagnosis, for example during surgery, intensive care, recuperation, or treatment. A variety of thermometers are used clinically and these can be separated into two categories, either contact (oral thermometers, rectal thermometers and temporal strips), or non-contact (ear thermometers, temporal thermometers and thermal imagers). To have the maximum confidence in the clinical performance of the temperature measurement instrument it is strongly desirable that the device be traceably calibrated to the International Temperature Scale of 1990 (ITS-90). Lack of traceable calibrations accredited to ISO17025 can lead to unreliability in temperature measurement and in some cases can have a deleterious effect on patient care. The National Physical Laboratory (NPL) maintains and disseminates the ITS-90 for contact and non-contact thermometry in the UK. The importance of accredited traceable calibrations and an outline of contact and non-contact thermometry standards are given here.

Fetoscopic treatment for discordant twins.

BACKGROUND/PURPOSE: In rare instances in monochorionic twin pregnancies, one twin can have a discordant anomaly (eg, cystic hygroma). If this twin dies in utero, neurologic injury and death can occur in the surviving cotwin. To protect the normal twin, the authors developed an approach to separate the circulations and ablate the umbilical cord of the abnormal twin. METHODS: From September 1998 to February 2001, 6 cases of discordant anomalous twins were diagnosed by prenatal ultrasound scan in which the anomaly was lethal or parents desired prenatal termination for this abnormal twin. All underwent surgical intervention with gestational ages varying from 19 to 24 weeks. RESULTS: Depending on cord insertion site and placental anatomy, blood flow was interrupted to the anomalous fetus by either radiofrequency ablation (RFA; 2 cases), cord transection (1 case), or cord transection after laser ablation of communicating vessels (3 cases). Fetal death occurred in one normal twin 4 days postoperatively. Average age at delivery for the 5 surviving fetuses was 34.5 weeks' gestation. On follow-up, all surviving infants are neurologically intact. CONCLUSION: An otherwise normal monochorionic twin threatened by an anomalous cotwin can be salvaged successfully with a strategy tailored to interrupt the vascular connections between the 2 twins.

Placentation in multiple births.

Outcomes of multifetal pregnancy in prenatal life are markedly affected by chorionicity. Several disease processes are found in monochorionic (MC) twins that do not occur in dichorionic (DC) twins. Improvements in prenatal outcomes will depend on reliable first trimester diagnosis of chorionicity, allowing early monitoring for complications of MC placentation. Particular structures and functions of MC twin placentas affect outcomes and can be targeted for specific treatments, especially in twin-twin transfusion. The causes of severe DC twin fetal growth discordance are clarified. In post-natal life, zygosity is a determining effect in genetic predisposition to many chronic diseases, including neoplasia. Few MC twins know that they are monozygotic (MZ). Few twin researchers realize that MZ twins may be genetically discordant. Abandonment of the word "identical" for MZ twins would assist in clarifying these issues of zygosity, concordance and discordance.