The potential role of sensors, wearables and telehealth in the remote management of diabetes-related foot disease

Diabetes-related foot disease (DFD), which includes foot ulcers, infection and gangrene,is a leading cause of the global disability burden. About half of people who develop DFD experience a recurrence within one year. Long-term medical management to reduce the risk of recurrence is therefore important to reduce the global DFD burden. This review describes research assessing the value of sensors, wearables and telehealth in preventing DFD. Sensors and wearables have been developed to monitor foot temperature, plantar pressures, glucose, blood pressure and lipids. The monitoring of these risk factors along with telehealth consultations has promise as a method for remotely managing people who are at risk of DFD. This approach can potentially avoid or reduce the need for face-to-face consultations. Home foot temperature monitoring, continuous glucose monitoring and telehealth consultations are the approaches for which the most highly developed and user-friendly technology has been developed. A number of clinical studies in people at risk of DFD have demonstrated benefits when using one of these remote monitoring methods. Further development and evidence are needed for some of the other approaches, such as home plantar pressure and footwear adherence monitoring. As yet, no composite remote management program incorporating remote monitoring and the management of all the key risk factors for DFD has been developed and implemented. Further research assessing the feasibility and value of combining these remote monitoring approaches as a holistic way of preventing DFD is needed

Lower limb biomechanical characetristics of patients with neuropathic diabetic foot ulcers: The diabetes foot ulcer study protocol

Background  Foot ulceration is the main precursor to lower limb amputation in patients with type 2 diabetes worldwide. Biomechanical factors have been implicated in the development of foot ulceration; however the association of these factors to ulcer healing remains less clear. It may be hypothesised that abnormalities in temporal spatial parameters (stride to stride measurements), kinematics (joint movements), kinetics (forces on the lower limb) and plantar pressures (pressure placed on the foot during walking) contribute to foot ulcer healing. The primary aim of this study is to establish the biomechanical characteristics (temporal spatial parameters, kinematics, kinetics and plantar pressures) of patients with plantar neuropathic foot ulcers compared to controls without a history of foot ulcers. The secondary aim is to assess the same biomechanical characteristics in patients with foot ulcers and controls over-time to assess whether these characteristics remain the same or change throughout ulcer healing.  Methods/Design  The design is a case–control study nested in a six-month longitudinal study. Cases will be participants with active plantar neuropathic foot ulcers (DFU group). Controls will consist of patients with type 2 diabetes (DMC group) and healthy participants (HC group) with no history of foot ulceration. Standardised gait and plantar pressure protocols will be used to collect biomechanical data at baseline, three and six months. Descriptive variables and primary and secondary outcome variables will be compared between the three groups at baseline and follow-up.  Discussion  It is anticipated that the findings from this longitudinal study will provide important information regarding the biomechanical characteristic of type 2 diabetes patients with neuropathic foot ulcers. We hypothesise that people with foot ulcers will demonstrate a significantly compromised gait pattern (reduced temporal spatial parameters, kinematics and kinetics) at base line and then throughout the follow-up period compared to controls. The study may provide evidence for the design of gait-retraining, neuro-muscular conditioning and other approaches to off-load the limbs of those with foot ulcers in order to reduce the mechanical loading on the foot during gait and promote ulcer healing

The reproducibility of acquiring three dimensional gait and plantar pressure data using established protocols in participants with and without type 2 diabetes and foot ulcers

Background  Several prospective studies have suggested that gait and plantar pressure abnormalities secondary to diabetic peripheral neuropathy contributes to foot ulceration. There are many different methods by which gait and plantar pressures are assessed and currently there is no agreed standardised approach. This study aimed to describe the methods and reproducibility of three-dimensional gait and plantar pressure assessments in a small subset of participants using pre-existing protocols.  Methods  Fourteen participants were conveniently sampled prior to a planned longitudinal study; four patients with diabetes and plantar foot ulcers, five patients with diabetes but no foot ulcers and five healthy controls. The repeatability of measuring key biomechanical data was assessed including the identification of 16 key anatomical landmarks, the measurement of seven leg dimensions, the processing of 22 three-dimensional gait parameters and the analysis of four different plantar pressures measures at 20 foot regions.  Results  The mean inter-observer differences were within the pre-defined acceptable level (<7mm) for 100% (16 of 16) of key anatomical landmarks measured for gait analysis. The intra-observer assessment concordance correlation coefficients were > 0.9 for 100% (7 of 7) of leg dimensions. The coefficients of variations (CVs) were within the pre-defined acceptable level (<10%) for 100% (22 of 22) of gait parameters. The CVs were within the pre-defined acceptable level (<30%) for 95% (19 of 20) of the contact area measures, 85% (17 of 20) of mean plantar pressures, 70% (14 of 20) of pressure time integrals and 55% (11 of 20) of maximum sensor plantar pressure measures.  Conclusion  Overall, the findings of this study suggest that important gait and plantar pressure measurements can be reliably acquired. Nearly all measures contributing to three-dimensional gait parameter assessments were within predefined acceptable limits. Most plantar pressure measurements were also within predefined acceptable limits; however, reproducibility was not as good for assessment of the maximum sensor pressure. To our knowledge, this is the first study to investigate the reproducibility of several biomechanical methods in a heterogeneous cohort

Standardising practices improves ambulatory diabetic foot management and reduces amputations: the Queensland Diabetic Foot Innovation Project, 2006 – 2009

Background Diabetic foot complications are recognised as the most common reason for diabetic related hospitalisation and lower extremity amputations. Multi-faceted strategies to reduce diabetic foot hospitalisation and amputation rates have been successful. However, most diabetic foot ulcers are managed in ambulatory settings where data availability is poor and studies limited. The project aimed to develop and evaluate strategies to improve the management of diabetic foot complications in three diverse ambulatory settings and measure the subsequent impact on ospitalisation and amputation. Methods Multifaceted strategies were implemented in 2008, including: multi-disciplinary teams, clinical pathways and training, clinical indicators, telehealth support and surveys. A retrospective audit of consecutive patient records from July 2006 – June 2007 determined baseline clinical indicators (n = 101). A clinical pathway teleform was implemented as a clinical record and clinical indicator analyser in all sites in 2008 (n = 327) and followed up in 2009 (n = 406). Results Prior to the intervention, clinical pathways were not used and multi-disciplinary teams were limited. There was an absolute improvement in treating according to risk of 15% in 2009 and surveillance of the high risk population of 34% and 19% in 2008 and 2009 respectively (p 92% in perfusion, ulcer depth, infection assessment and management, offloading and education. Hospitalisation impacts recorded reductions of up to 64% in amputation rates / 100,000 population (p < 0.001) and 24% average length of stay (p < 0.001) Conclusion These findings support the use of multi-faceted strategies in diverse ambulatory services to standardise practice, improve diabetic foot complications management and positively impact on hospitalisation outcomes. As of October 2010, these strategies had been rolled out to over 25 ambulatory sites, representing 66% of Queensland Health districts, managing 1,820 patients and 13,380 occasions of service, including 543 healed ulcer patients. It is expected that this number will rise dramatically as an incentive payment for the use of the teleform is expanded

Optimal combination of signals from co-located gravitational wave interferometers for use in searches for a stochastic background

This article derives an optimal (i.e., unbiased, minimum variance) estimator for the pseudo-detector strain for a pair of co-located gravitational wave interferometers (such as the pair of LIGO interferometers at its Hanford Observatory), allowing for possible instrumental correlations between the two detectors. The technique is robust and does not involve any assumptions or approximations regarding the relative strength of gravitational wave signals in the detector pair with respect to other sources of correlated instrumental or environmental noise. An expression is given for the effective power spectral density of the combined noise in the pseudo-detector. This can then be introduced into the standard optimal Wiener filter used to cross-correlate detector data streams in order to obtain an optimal estimate of the stochastic gravitational wave background. In addition, a dual to the optimal estimate of strain is derived. This dual is constructed to contain no gravitational wave signature and can thus be used as on "off-source" measurement to test algorithms used in the "on-source" observation.Comment: 14 pages, 4 figures, submitted to Physical Review D Resubmitted after editing paper in response to referee comments. Removed appendices A, B and edited text accordingly. Improved legibility of figures. Corrected several references. Corrected reference to science run number (S1 vs. S2) in text and figure caption

Does the use of store-and-forward telehealth systems improve outcomes for clinicians managing diabetic foot ulcers? A pilot study

Diabetic foot ulcers are one of the most hospitalised diabetes complications and contribute to many leg amputations.\ud Trained diabetic foot teams and specialists managing diabetic foot ulcers have demonstrated reductions in amputations and hospitalisation by up to 90%. Few such teams exist in Australia. Thus, access is limited for all geographical populations and may somewhat explain the high rates of hospitalisation.\ud Aim: This pilot study aims to analyse if local clinicians managing diabetic foot complications report improved access to diabetic foot specialists and outcomes with the introduction of a telehealth store-and-forward system.\ud Method: A store-and-forward telehealth system was implemented in six different Queensland locations between August 2009 and February 2010. Sites were offered ad hoc and/or fortnightly telehealth access to a diabetic foot speciality service. A survey was sent six months following commencement of the trial to the 14 eligible clinicians involved in the trial to gauge clinical perception of the telehealth system.\ud Results: Eight participants returned the surveys. The majority of responding clinicians reported that the telehealth system was easy to use (100%), improved their access to diabetic foot speciality services (75%), improved upskilling of local diabetes service staff (100%), and improved patient outcomes (100%).\ud Conclusion: This pilot study suggests that clinicians found the use of a telehealth store-and-forward system very useful in improving access to speciality services, clinical skills and patient outcomes. This study supports the recommendation that telehealth systems should be made available for diabetic foot ulcer management

Should weight-bearing activity be reduced during healing of plantar diabetic foot ulcers, even when using appropriate offloading devices?

Physical activity is an essential part of general health and diabetes management. However, recommending weight-bearing physical activity for people with plantar diabetic foot ulcers is controversial, even when gold standard offloading devices are used, as it is commonly thought to delay healing. We aimed to narratively review relevant studies investigating the relationship between plantar diabetic foot ulcer healing and weight-bearing activity, plantar pressure and device adherence. We defined relevant studies as those from two systematic reviews, along with those identified since using a similar updated Pubmed search strategy. We identified six studies. One study found that more daily steps were associated with worse ulcer healing, three found no significant association between steps and ulcer healing, and in two others the association was unclear. Thus, there is weak evidence for an inverse relationship between weight-bearing physical activity and plantar ulcer healing while utilizing offloading devices. We propose a Diabetic foot Offloading and Activity framework to guide future research to find the optimal balance between the positive and negative effects of weight-bearing activity in the context of foot ulcers. We hope such future studies will shed more conclusive light on the impact of weight-bearing activity on healing of plantar diabetic foot ulcers

Intensive versus conventional glycaemic control for treating diabetic foot ulcers

Background&nbsp; The estimated likelihood of lower limb amputation is 10 to 30 times higher amongst people with diabetes compared to those without diabetes. Of all non-traumatic amputations in people with diabetes, 85% are preceded by a foot ulcer. Foot ulceration associated with diabetes (diabetic foot ulcers) is caused by the interplay of several factors, most notably diabetic peripheral neuropathy (DPN), peripheral arterial disease (PAD) and changes in foot structure. These factors have been linked to chronic hyperglycaemia (high levels of glucose in the blood) and the altered metabolic state of diabetes. Control of hyperglycaemia may be important in the healing of ulcers.&nbsp; Objectives&nbsp; To assess the effects of intensive glycaemic control compared to conventional control on the outcome of foot ulcers in people with type 1 and type 2 diabetes.&nbsp; Search methods&nbsp; In December 2015 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process &amp; Other Non-Indexed Citations); Ovid EMBASE; EBSCO CINAHL; Elsevier SCOPUS; ISI Web of Knowledge Web of Science; BioMed Central and LILACS. We also searched clinical trial databases, pharmaceutical trial databases and current international and national clinical guidelines on diabetes foot management for relevant published, non-published, ongoing and terminated clinical trials. There were no restrictions based on language or date of publication or study setting.&nbsp; Selection criteria&nbsp; Published, unpublished and ongoing randomised controlled trials (RCTs) were considered for inclusion where they investigated the effects of intensive glycaemic control on the outcome of active foot ulcers in people with diabetes. Non randomised and quasi-randomised trials were excluded. In order to be included the trial had to have: 1) attempted to maintain or control blood glucose levels and measured changes in markers of glycaemic control (HbA1c or fasting, random, mean, home capillary or urine glucose), and 2) documented the effect of these interventions on active foot ulcer outcomes. Glycaemic interventions included subcutaneous insulin administration, continuous insulin infusion, oral anti-diabetes agents, lifestyle interventions or a combination of these interventions. The definition of the interventional (intensive) group was that it should have a lower glycaemic target than the comparison (conventional) group.&nbsp; Data collection and analysis&nbsp; All review authors independently evaluated the papers identified by the search strategy against the inclusion criteria. Two review authors then independently reviewed all potential full-text articles and trials registry results for inclusion.&nbsp; Main results&nbsp; We only identified one trial that met the inclusion criteria but this trial did not have any results so we could not perform the planned subgroup and sensitivity analyses in the absence of data. Two ongoing trials were identified which may provide data for analyses in a later version of this review. The completion date of these trials is currently unknown.&nbsp; Authors&rsquo; conclusions&nbsp; The current review failed to find any completed randomised clinical trials with results. Therefore we are unable to conclude whether intensive glycaemic control when compared to conventional glycaemic control has a positive or detrimental effect on the treatment of foot ulcers in people with diabetes. Previous evidence has however highlighted a reduction in risk of limb amputation (from various causes) in people with type 2 diabetes with intensive glycaemic control. Whether this applies to people with foot ulcers in particular is unknown. The exact role that intensive glycaemic control has in treating foot ulcers in multidisciplinary care (alongside other interventions targeted at treating foot ulcers) requires further investigation

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