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"Armstrong, David G"
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The Potential Role of Sensors, Wearables and Telehealth in the Remote Management of Diabetes-Related Foot Disease
2020
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.
Journal Article
Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer
by
Padula, William V.
,
Swerdlow, Mark A.
,
Armstrong, Alexandria A.
in
Amputation
,
Amputation, Surgical - economics
,
Amputation, Surgical - mortality
2020
Background
In 2007, we reported a summary of data comparing diabetic foot complications to cancer. The purpose of this brief report was to refresh this with the best available data as they currently exist. Since that time, more reports have emerged both on cancer mortality and mortality associated with diabetic foot ulcer (DFU), Charcot arthropathy, and diabetes-associated lower extremity amputation.
Methods
We collected data reporting 5-year mortality from studies published following 2007 and calculated a pooled mean. We evaluated data from DFU, Charcot arthropathy and lower extremity amputation. We dichotomized high and low amputation as proximal and distal to the ankle, respectively. This was compared with cancer mortality as reported by the American Cancer Society and the National Cancer Institute.
Results
Five year mortality for Charcot, DFU, minor and major amputations were 29.0, 30.5, 46.2 and 56.6%, respectively. This is compared to 9.0% for breast cancer and 80.0% for lung cancer. 5 year pooled mortality for all reported cancer was 31.0%.
Direct costs of care for diabetes in general was $237 billion in 2017. This is compared to $80 billion for cancer in 2015. As up to one-third of the direct costs of care for diabetes may be attributed to the lower extremity, these are also readily comparable.
Conclusion
Diabetic lower extremity complications remain enormously burdensome. Most notably, DFU and LEA appear to be more than just a marker of poor health. They are independent risk factors associated with premature death. While advances continue to improve outcomes of care for people with DFU and amputation, efforts should be directed at primary prevention as well as those for patients in diabetic foot ulcer remission to maximize ulcer-free, hospital-free and activity-rich days.
Journal Article
A Diabetic Emergency One Million Feet Long: Disparities and Burdens of Illness among Diabetic Foot Ulcer Cases within Emergency Departments in the United States, 2006–2010
2015
To evaluate the magnitude and impact of diabetic foot ulcers (DFUs) in emergency department (ED) settings from 2006-2010 in the United States (US).
This cross-sectional study utilized Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) National Emergency Department Sample (NEDS) discharge records of ED cases among persons ≥18 years with any-listed diagnosis of DFUs. Multivariable analyses were conducted for clinical outcomes of patient disposition from the ED and economic outcomes of charges and lengths of stay based upon patient demographic and socioeconomic factors, hospital characteristics, and comorbid disease states.
Overall, 1,019,861 cases of diabetic foot complications presented to EDs in the US from 2006-2010, comprising 1.9% of the 54.2 million total diabetes cases. The mean patient age was 62.5 years and 59.4% were men. The national bill was $1.9 billion per year in the ED and $8.78 billion per year (US$ 2014) including inpatient charges among the 81.2% of cases that were admitted. Clinical outcomes included mortality in 2.0%, sepsis in 9.6% of cases and amputation in 10.5% (major-minor amputation ratio of 0.46). Multivariable analyses found that those residing in non-urban locations were associated with +51.3%, +14.9%, and +41.4% higher odds of major amputation, minor amputation, and inpatient death, respectively (p<0.05). Medicaid beneficiaries incurred +21.1% and +25.1% higher odds for major or minor amputations, respectively, than Medicare patients (p<0.05). Persons within the lowest income quartile regions were associated with a +38.5% higher odds of major amputation (p<0.05) versus the highest income regions.
Diabetic foot complications exact a substantial clinical and economic toll in acute care settings, particularly among the rural and working poor. Clear opportunities exist to reduce costs and improve outcomes for this systematically-neglected condition by establishing effective practice paradigms for screening, prevention, and coordinated care.
Journal Article
Disparities in outcomes of patients admitted with diabetic foot infections
by
Shih, Chia-Ding
,
Tan, Tze-Woei
,
Concha-Moore, Kirsten C.
in
African Americans
,
Amputation
,
Analysis
2019
The purpose of this study was to evaluate the disparities in the outcomes of White, African American (AA) and non-AA minority (Hispanics and Native Americans (NA)), patients admitted in the hospitals with diabetic foot infections (DFIs).
The HCUP-Nationwide Inpatient Sample (2002 to 2015) was queried to identify patients who were admitted to the hospital for management of DFI using ICD-9 codes. Outcomes evaluated included minor and major amputations, open or endovascular revascularization, and hospital length of stay (LOS). Incidence for amputation and open or endovascular revascularization were evaluated over the study period. Multivariable regression analyses were performed to assess the association between race/ethnicity and outcomes.
There were 150,701 admissions for DFI, including 98,361 Whites, 24,583 AAs, 24,472 Hispanics, and 1,654 Native Americans (NAs) in the study cohort. Overall, 45,278 (30%) underwent a minor amputation, 9,039 (6%) underwent a major amputation, 3,151 underwent an open bypass, and 8,689 had an endovascular procedure. There was a decreasing incidence in major amputations and an increasing incidence of minor amputations over the study period (P < .05). The risks for major amputation were significantly higher (all p<0.05) for AA (OR 1.4, 95%CI 1.4,1.5), Hispanic (OR 1.3, 95%CI 1.3,1.4), and NA (OR 1.5, 95%CI 1.2,1.8) patients with DFIs compared to White patients. Hispanics (OR 1.3, 95%CI 1.2,1.5) and AAs (OR 1.2, 95%CI 1.1,1.4) were more likely to receive endovascular intervention or open bypass than Whites (all p<0.05). NA patients with DFI were less likely to receive a revascularization procedure (OR 0.6, 95%CI 0.3, 0.9, p = 0.03) than Whites. The mean hospital length of stay (LOS) was significantly longer for AAs (9.2 days) and Hispanics (8.6 days) with DFIs compared to Whites (8.1 days, p<0.001).
Despite a consistent incidence reduction of amputation over the past decade, racial and ethnic minorities including African American, Hispanic, and Native American patients admitted to hospitals with DFIs have a consistently significantly higher risk of major amputation and longer hospital length of stay than their White counterparts. Native Americans were less likely to receive revascularization procedures compared to other minorities despite exhibiting an elevated risk of an amputation. Further study is required to address and limit racial and ethnic disparities and to further promote equity in the treatment and outcomes of these at-risk patients.
Journal Article
Point‐of‐care fluorescence imaging reveals extent of bacterial load in diabetic foot ulcers
by
Serena, Thomas E.
,
Armstrong, David G.
,
Edmonds, Michael E.
in
Amputation
,
Bacteria
,
Bacterial infections
2023
Elevated levels of bacteria, including biofilm, increase the risk of chronic wound infection and inhibit healing. Addressing asymptomatic high bacterial loads is challenged by a lack of clinical terminology and diagnostic tools. This post‐hoc multicenter clinical trial analysis of 138 diabetic foot ulcers investigates fluorescence (FL)‐imaging role in detecting biofilm‐encased and planktonic bacteria in wounds at high loads. The sensitivity and specificity of clinical assessment and FL‐imaging were compared across bacterial loads of concern (104–109 CFU/g). Quantitative tissue culture confirmed the total loads. Bacterial presence was confirmed in 131/138 ulcers. Of these, 93.9% had loads >104 CFU/g. In those wounds, symptoms of infection were largely absent and did not correlate with, or increase proportionately with, bacterial loads at any threshold. FL‐imaging increased sensitivity for the detection of bacteria across loads 104–109 (P < .0001), peaking at 92.6% for >108 CFU/g. Imaging further showed that 84.2% of ulcers contained high loads in the periwound region. New terminology, chronic inhibitory bacterial load (CIBL), describes frequently asymptomatic, high bacterial loads in diabetic ulcers and periwound tissues, which require clinical intervention to prevent sequelae of infection. We anticipate this will spark a paradigm shift in assessment and management, enabling earlier intervention along the bacterial‐infection continuum and supporting improved wound outcomes.
Journal Article
SmartBoot: Real-Time Monitoring of Patient Activity via Remote Edge Computing Technologies
2025
Diabetic foot ulcers (DFUs) are a serious complication of diabetes, associated with high recurrence and amputation rates. Adherence to offloading devices is critical for wound healing but remains inadequately monitored in real-world settings. This study evaluates the SmartBoot edge-computing system—a wearable, real-time remote monitoring solution integrating an inertial measurement unit (Sensoria Core) and smartwatch—for its validity in quantifying cadence and step count as digital biomarkers of frailty, and for detecting adherence. Twelve healthy adults wore two types of removable offloading boots (Össur and Foot Defender) during walking tasks at varied speeds; system outputs were validated against a gold-standard wearable and compared with staff-recorded adherence logs. Additionally, user experience was assessed using the Technology Acceptance Model (TAM) in healthy participants (n = 12) and patients with DFU (n = 81). The SmartBoot demonstrated high accuracy in cadence and step count across conditions (bias < 5.5%), with an adherence detection accuracy of 96% (Össur) and 97% (Foot Defender). TAM results indicated strong user acceptance and perceived ease of use across both cohorts. These findings support the SmartBoot system’s potential as a valid, scalable solution for real-time remote monitoring of adherence and mobility in DFU management. Further clinical validation in ongoing studies involving DFU patients is underway.
Journal Article
Bacterial Diversity of Diabetic Foot Ulcers: Current Status and Future Prospectives
2019
Diabetic foot ulcers (DFUs) and diabetic foot infections (DFIs) are associated with reduced patient quality of life, lower-extremity amputation, hospitalization, and high morbidity and mortality. Diverse bacterial communities have been identified in DFUs/DFIs, playing a significant role in infection prognosis. However, due to the high heterogeneity of bacterial communities colonized in DFUs/DFIs, culture-based methods may not isolate all of the bacterial population or unexpected microorganisms. Recently, high sensitivity and specificity of DNA (metagenomics) and RNA (metatranscriptomics) technologies have addressed limitations of culture-based methods and have taken a step beyond bacterial identification. As a consequence, new advances obtained from DNA- and RNA-based techniques for bacterial identification can improve therapeutic approaches. This review evaluated the current state of play in aetiology of DFUs/DFIs on culture and molecular approaches, and discussed the impact of metagenomic and metatranscriptomic methods in bacterial identification approaches.
Journal Article
Adherence and the Diabetic Foot: High Tech Meets High Touch?
by
Armstrong, David G.
,
Ead, J. Karim
,
Srass, Hadia
in
adherence
,
Artificial Intelligence
,
Cardiovascular disease
2023
Diabetic foot ulcers, which are a common complication of diabetes, can have a negative impact on a person’s physical and mental health, including an increased risk of depression. Patients suffering from depression are less likely to keep up with diabetic foot care, thus increasing the risk of developing ulcers. However, with the use of artificial intelligence (AI), at-home patient care has become easier, which increases adherence. To better understand how new technologies, including machine learning algorithms and wearable sensors, might improve patient adherence and outcomes, we conducted a literature review of several sensor technologies, including SmartMat© and Siren Care© socks for temperature, SurroSense Rx/Orpyx© for pressure, and Orthotimer© for adherence. An initial search identified 143 peer-reviewed manuscripts, from which we selected a total of 10 manuscripts for further analysis. We examined the potential benefits of personalized content and clinician support for those receiving mobile health interventions. These findings may help to demonstrate the current and future utility of advanced technologies in improving patient adherence and outcomes, particularly in the context of diabetes management and the link between behavior and complications in diabetes, such as diabetic foot ulcers.
Journal Article
AI-Guided Remission: Protocol for a Conversational Agent (Chatbot) for Dosing Activity and Footwear Progression After Diabetic Limb Reconstruction
by
Antoszewska, Magdalena
,
Klonoff, David C.
,
Feraru, Lucian M.
in
activity dosing
,
Artificial Intelligence
,
chatbot
2026
Background: Diabetic foot ulcers recur frequently after healing. The first three months carry the highest risk. Remission is a vulnerable phase that demands precise self-care and timely feedback. Evidence supports thermometry and protective footwear with gradual return to activity, yet adherence at home is inconsistent. Objective: To describe the design and planned evaluation of a conversational agent (chatbot) that guides patients through the remission phase following diabetic limb reconstruction. Methods: This protocol describes a conversational agent (chatbot) that turns remission guidance into daily actions, grounded in clinical expertise and established care guidelines. Walking is dosed like a drug, with careful titration based on tissue response. The agent integrates automatic data capture (smartphone step counts, skin temperature, shoe step streams, smartwatch step streams, Bluetooth thermometry when available, and app session timestamps) with manual patient entries (shoe wear time, skin redness persistence, and symptom checks). It doses walking activity, guides footwear break-in, prompts photo-confirmed concerns, following clinician-informed rules and escalation pathways. We define data quality checks for missingness and physiologic plausibility, and the agent reinforces reducing weight-bearing activity when risk signals appear. We outline device drift. The study is designed as a single-arm feasibility pilot (n = 30) to assess engagement, safety, and implementation fidelity. Results: No clinical outcome results are reported because this is a protocol study and enrollment has not yet begun. This study presents the prespecified sensing-to-decision workflow, escalation logic, and pilot endpoints, along with internal technical verification procedures (e.g., message delivery reliability, data completeness checks, and rule-engine consistency testing). Conclusions: A remission chatbot is a plausible method to extend specialist support into the home, reflecting integration of clinical expertise with digital health tools. This protocol defines how feasibility, safety, and usability will be evaluated. Clinical efficacy should be confirmed in future studies.
Journal Article
The Influence of Diabetic Peripheral Neuropathy on Local Postural Muscle and Central Sensory Feedback Balance Control
by
Mohler, Jane
,
Toosizadeh, Nima
,
Armstrong, David G.
in
Accidental Falls - prevention & control
,
Accidental Falls - statistics & numerical data
,
Adaptation
2015
Poor balance control and increased fall risk have been reported in people with diabetic peripheral neuropathy (DPN). Traditional body sway measures are unable to describe underlying postural control mechanism. In the current study, we used stabilogram diffusion analysis to examine the mechanism under which balance is altered in DPN patients under local-control (postural muscle control) and central-control (postural control using sensory cueing). DPN patients and healthy age-matched adults over 55 years performed two 15-second Romberg balance trials. Center of gravity sway was measured using a motion tracker system based on wearable inertial sensors, and used to derive body sway and local/central control balance parameters. Eighteen DPN patients (age = 65.4±7.6 years; BMI = 29.3±5.3 kg/m2) and 18 age-matched healthy controls (age = 69.8±2.9; BMI = 27.0±4.1 kg/m2) with no major mobility disorder were recruited. The rate of sway within local-control was significantly higher in the DPN group by 49% (healthy local-controlslope = 1.23±1.06×10-2 cm2/sec, P<0.01), which suggests a compromised local-control balance behavior in DPN patients. Unlike local-control, the rate of sway within central-control was 60% smaller in the DPN group (healthy central-controlslope-Log = 0.39±0.23, P<0.02), which suggests an adaptation mechanism to reduce the overall body sway in DPN patients. Interestingly, significant negative correlations were observed between central-control rate of sway with neuropathy severity (rPearson = 0.65-085, P<0.05) and the history of diabetes (rPearson = 0.58-071, P<0.05). Results suggest that in the lack of sensory feedback cueing, DPN participants were highly unstable compared to controls. However, as soon as they perceived the magnitude of sway using sensory feedback, they chose a high rigid postural control strategy, probably due to high concerns for fall, which may increase the energy cost during extended period of standing; the adaptation mechanism using sensory feedback depends on the level of neuropathy and the history of diabetes.
Journal Article