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Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot

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A special issue of Sensors (ISSN 1424-8220). This special issue belongs to the section "Physical Sensors".

Deadline for manuscript submissions: closed (30 September 2023) | Viewed by 36176

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Special Issue Editors

Prof. Dr. Neil D. Reeves

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Guest Editor

Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Oxford Road, Manchester M1 5GD, UK
Interests: diabetic foot ulcer prevention; digital technologies and medical devices in diabetic foot research; gait impairment in diabetes; exercise-based interventions

Prof. Dr. Christopher Nester

E-Mail Website
Guest Editor

School of Health & Society, University of Salford, Salford M5 4WT, UK
Interests: foot and lower limb biomechanics; footwear and orthotic design; factors impacting on foot health; orthotics; health

Special Issue Information

Dear Colleagues,

Diabetic foot ulcers (DFU) represent one of the most challenging complications of diabetes. One in three people with diabetes develop a foot ulcer, and many cases require amputation. The economic costs and five-year mortality associated with DFU are worse than breast and prostate cancers.

Primary prevention of DFU is the key to addressing this health issue. However, prevention is challenging because of the complexity of health behaviours that lead to most cases of diabetes and specific foot factors including diabetic peripheral neuropathy, which makes patient self-monitoring difficult. Major opportunities exist for sensing and monitoring technologies that can help support patients to better manage their foot health and health behaviours important to diabetes management, and work towards preventing DFU and subsequent amputations.

This Special Issue will address topic areas that support diabetes patients to screen, measure and monitor key parameters and foot health indicators, with examples of data signals including the foot temperature, pressure, blood flow/pressure, humidity, visual images/scans and other technologies that are markers of health behaviours impacting foot health. This can include early-stage engineering, information communication and technology development, or later-stage applied patient trials.

We welcome scientific advancements in this field through original research articles, case series and literature reviews.

Prof. Dr. Neil D. Reeves
Prof. Dr. Christopher Nester
Guest Editors

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Keywords

foot
ulcer
diabetes
pressure
temperature
skin
vascular
insoles
footwear

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Published Papers (11 papers)

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Research

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13 pages, 225 KiB

Open AccessArticle

In-Shoe Pressure Measurements in Diabetic Footwear Practice: Success Rate and Facilitators of and Barriers to Implementation

by Jennefer B. J. Zwaferink, Frans Nollet and Sicco A. Bus

Sensors 2024, 24(6), 1795; https://doi.org/10.3390/s24061795 - 11 Mar 2024

Cited by 1 | Viewed by 1122

Abstract

We aimed to assess the success rate and facilitators of and the barriers to the implementation of in-shoe plantar pressure measurements in footwear practice for people with diabetes at high risk of foot ulceration. Eleven Dutch footwear practices were partly supported in purchasing a pressure measurement system. Over a 2.5-year period, trained shoe technicians evaluated 1030 people with diabetes (range: 13 to 156 across practices). The implementation success and associated facilitators and barriers were evaluated quantitatively using completed measurement forms and pressure measurement data obtained during four monitoring sessions and qualitatively through semi-structured interviews with technicians. Across the 11 practices, the primary target group (people with diabetes and a healed plantar foot ulcer) represented 25–90% of all the patients measured. The results showed that three practices were successful, five moderately successful, and three not successful. The facilitators included support by the company management board, collaboration with a prescribing physician, measurement sessions separate from the outpatient clinic, and a (dedicated) shoe technician experiencing a learning effect. The barriers included investment costs, usability aspects, and limited awareness among shoe technicians. In-shoe plantar pressure measurements can be implemented to a moderate to large degree in diabetic footwear practice. The barriers to and facilitators of implementation are organizational, logistical, financial, or technical, and the barriers are modifiable, supporting future implementation. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

11 pages, 5616 KiB

Open AccessArticle

Habitual Physical Activity of People with or at Risk of Diabetes-Related Foot Complications

by Byron M. Perrin, Dimitri Diacogiorgis, Courtney Sullivan, James Gerrard, Isabelle Skinner, Timothy C. Skinner, Rashmika Nawaratne, Damminda Alahakoon and Michael I. C. Kingsley

Sensors 2023, 23(13), 5822; https://doi.org/10.3390/s23135822 - 22 Jun 2023

Viewed by 2555

Abstract

Regular physical activity is an important component of diabetes management. However, there are limited data on the habitual physical activity of people with or at risk of diabetes-related foot complications. The aim of this study was to describe the habitual physical activity of people with or at risk of diabetes-related foot complications in regional Australia. Twenty-three participants with diabetes from regional Australia were recruited with twenty-two participants included in subsequent analyses: no history of ulcer (N = 11) and history of ulcer (N = 11). Each participant wore a triaxial accelerometer (GT3X+; ActiGraph LLC, Pensacola, FL, USA) on their non-dominant wrist for 14 days. There were no significant differences between groups according to both participant characteristics and physical activity outcomes. Median minutes per day of moderate-to-vigorous physical activity (MVPA) were 9.7 (IQR: 1.6–15.7) while participants recorded an average of 280 ± 78 min of low-intensity physical activity and 689 ± 114 min of sedentary behaviour. The sample accumulated on average 30 min of slow walking and 2 min of fast walking per day, respectively. Overall, participants spent very little time performing MVPA and were largely sedentary. It is important that strategies are put in place for people with or at risk of diabetes-related foot complications in order that they increase their physical activity significantly in accordance with established guidelines. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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10 pages, 554 KiB

Open AccessArticle

The Validity and Reliability of Self-Reported Adherence to Using Offloading Treatment in People with Diabetes-Related Foot Ulcers

by Anas Ababneh, Kathleen Finlayson, Helen Edwards, David G. Armstrong, Bijan Najafi, Jaap J. van Netten and Peter A. Lazzarini

Sensors 2023, 23(9), 4423; https://doi.org/10.3390/s23094423 - 30 Apr 2023

Cited by 4 | Viewed by 2385

Abstract

Adherence to using offloading treatment is crucial to healing diabetes-related foot ulcers (DFUs). Offloading adherence is recommended to be measured using objective monitors. However, self-reported adherence is commonly used and has unknown validity and reliability. This study aimed to assess the validity and reliability of self-reported adherence to using removable cast walker (RCW) offloading treatment among people with DFUs. Fifty-three participants with DFUs using RCWs were included. Each participant self-reported their percentage adherence to using their RCW of total daily steps. Participants also had adherence objectively measured using dual activity monitors. After one week, a subset of 19 participants again self-reported their percentage adherence to investigate test–retest reliability. Validity was tested using Pearson’s r and Bland–Altman tests, and reliability using Cohen’s kappa. Median (IQR) self-reported adherence was greater than objectively measured adherence (90% (60–100) vs. 35% (19–47), p < 0.01). There was fair agreement (r = 0.46; p < 0.01) and large 95% limits of agreement with significant proportional bias (β = 0.46, p < 0.01) for validity, and minimal agreement for test–retest reliability (K = 0.36; p < 0.01). The validity and reliability of self-reported offloading adherence in people with DFU are fair at best. People with DFU significantly overestimate their offloading adherence. Clinicians and researchers should instead use objective adherence measures. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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15 pages, 3960 KiB

Open AccessEditor’s ChoiceArticle

A Wearable Insole System to Measure Plantar Pressure and Shear for People with Diabetes

by Jinghua Tang, Dan L. Bader, David Moser, Daniel J. Parker, Saeed Forghany, Christopher J. Nester and Liudi Jiang

Sensors 2023, 23(6), 3126; https://doi.org/10.3390/s23063126 - 15 Mar 2023

Cited by 17 | Viewed by 7312

Abstract

Pressure coupled with shear stresses are the critical external factors for diabetic foot ulceration assessment and prevention. To date, a wearable system capable of measuring in-shoe multi-directional stresses for out-of-lab analysis has been elusive. The lack of an insole system capable of measuring plantar pressure and shear hinders the development of an effective foot ulcer prevention solution that could be potentially used in a daily living environment. This study reports the development of a first-of-its-kind sensorised insole system and its evaluation in laboratory settings and on human participants, indicating its potential as a wearable technology to be used in real-world applications. Laboratory evaluation revealed that the linearity error and accuracy error of the sensorised insole system were up to 3% and 5%, respectively. When evaluated on a healthy participant, change in footwear resulted in approximately 20%, 75% and 82% change in pressure, medial–lateral and anterior–posterior shear stress, respectively. When evaluated on diabetic participants, no notable difference in peak plantar pressure, as a result of wearing the sensorised insole, was measured. The preliminary results showed that the performance of the sensorised insole system is comparable to previously reported research devices. The system has adequate sensitivity to assist footwear assessment relevant to foot ulcer prevention and is safe to use for people with diabetes. The reported insole system presents the potential to help assess diabetic foot ulceration risk in a daily living environment underpinned by wearable pressure and shear sensing technologies. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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10 pages, 1721 KiB

Open AccessArticle

Taking a Load Off: User Perceptions of Smart Offloading Walkers for Diabetic Foot Ulcers Using the Technology Acceptance Model

by M. G. Finco, Gozde Cay, Myeounggon Lee, Jason Garcia, Elia Salazar, Tze-Woei Tan, David G. Armstrong and Bijan Najafi

Sensors 2023, 23(5), 2768; https://doi.org/10.3390/s23052768 - 2 Mar 2023

Cited by 8 | Viewed by 4110

Abstract

People with diabetic foot ulcers (DFUs) are commonly prescribed offloading walkers, but inadequate adherence to prescribed use can be a barrier to ulcer healing. This study examined user perspectives of offloading walkers to provide insight on ways to help promote adherence. Participants were randomized to wear: (1) irremovable, (2) removable, or (3) smart removable walkers (smart boot) that provided feedback on adherence and daily walking. Participants completed a 15-item questionnaire based on the Technology Acceptance Model (TAM). Spearman correlations assessed associations between TAM ratings with participant characteristics. Chi-squared tests compared TAM ratings between ethnicities, as well as 12-month retrospective fall status. A total of 21 adults with DFU (age 61.5 ± 11.8 years) participated. Smart boot users reported that learning how to use the boot was easy (ρ =−0.82, p

\leq

0.001). Regardless of group, people who identified as Hispanic or Latino, compared to those who did not, reported they liked using the smart boot (p = 0.05) and would use it in the future (p = 0.04). Non-fallers, compared to fallers, reported the design of the smart boot made them want to wear it longer (p = 0.04) and it was easy to take on and off (p = 0.04). Our findings can help inform considerations for patient education and design of offloading walkers for DFUs. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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18 pages, 2347 KiB

Open AccessArticle

Self-Monitoring Diabetes-Related Foot Ulcers with the MyFootCare App: A Mixed Methods Study

by Bernd Ploderer, Damien Clark, Ross Brown, Joel Harman, Peter A. Lazzarini and Jaap J. Van Netten

Sensors 2023, 23(5), 2547; https://doi.org/10.3390/s23052547 - 24 Feb 2023

Cited by 7 | Viewed by 3956

Abstract

People with diabetes-related foot ulcers (DFUs) need to perform self-care consistently over many months to promote healing and to mitigate risks of hospitalisation and amputation. However, during that time, improvement in their DFU can be hard to detect. Hence, there is a need for an accessible method to self-monitor DFUs at home. We developed a new mobile phone app, “MyFootCare”, to self-monitor DFU healing progression from photos of the foot. The aim of this study is to evaluate the engagement and perceived value of MyFootCare for people with a plantar DFU over 3 months’ duration. Data are collected through app log data and semi-structured interviews (weeks 0, 3, and 12) and analysed through descriptive statistics and thematic analysis. Ten out of 12 participants perceive MyFootCare as valuable to monitor progress and to reflect on events that affected self-care, and seven participants see it as potentially valuable to enhance consultations. Three app engagement patterns emerge: continuous, temporary, and failed engagement. These patterns highlight enablers for self-monitoring (such as having MyFootCare installed on the participant’s phone) and barriers (such as usability issues and lack of healing progress). We conclude that while many people with DFUs perceive app-based self-monitoring as valuable, actual engagement can be achieved for some but not for all people because of various facilitators and barriers. Further research should target improving usability, accuracy and sharing with healthcare professionals and test clinical outcomes when using the app. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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12 pages, 2080 KiB

Open AccessArticle

Adherence and Wearing Time of Prescribed Footwear among People at Risk of Diabetes-Related Foot Ulcers: Which Measure to Use?

by Gustav Jarl, Chantal M. Hulshof, Tessa E. Busch-Westbroek, Sicco A. Bus and Jaap J. van Netten

Sensors 2023, 23(3), 1648; https://doi.org/10.3390/s23031648 - 2 Feb 2023

Cited by 10 | Viewed by 2477

Abstract

Adherence to prescribed footwear is essential to prevent diabetes-related foot ulcers. The aim was to compare different measures of adherence and wearing time of prescribed footwear with a reference adherence measure, among people with diabetes at high risk of foot ulceration. We followed 53 participants for 7 consecutive days. A temperature sensor measured wearing time of prescribed footwear and a triaxial accelerometer assessed weight-bearing activities. Subjective wearing time was self-reported. Reference adherence measure was proportion of weight-bearing time prescribed footwear was worn. We calculated Spearman’s correlation coefficients, kappa coefficients, and areas under the curve (AUC) for the association between the reference measure and other measures of adherence and wearing time. Proportion of daily steps with prescribed footwear worn had a very strong association (r = 0.96, Κ = 0.93; AUC: 0.96–1.00), objective wearing time had a strong association (r = 0.91, Κ = 0.85, AUC: 0.89–0.99), and subjective wearing time had a weak association (r = 0.42, Κ = 0.38, AUC: 0.67–0.81) with the reference measure. Objectively measured proportion of daily steps with prescribed footwear is a valid measure of footwear adherence. Objective wearing time is reasonably valid, and may be used in clinical practice and for long-term measurements. Subjective wearing time is not recommended to be used. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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17 pages, 1056 KiB

Open AccessArticle

Could an Internet-Based Foot–Ankle Therapeutic Exercise Program Modify Clinical Outcomes and Gait Biomechanics in People with Diabetic Neuropathy? A Clinical Proof-of-Concept Study

by Ronaldo H. Cruvinel-Júnior, Jane S. S. P. Ferreira, Jady L. Veríssimo, Renan L. Monteiro, Eneida Y. Suda, Érica Q. Silva and Isabel C. N. Sacco

Sensors 2022, 22(24), 9582; https://doi.org/10.3390/s22249582 - 7 Dec 2022

Cited by 2 | Viewed by 2537

Abstract

Previous studies have shown the efficacy of foot–ankle exercises in people with diabetic peripheral neuropathy (DPN), but the quality of evidence is still low. This proof-of-concept study pursues preliminary evidence for potential clinical and gait biomechanical benefits from an internet-based foot–ankle therapeutic exercise program for people with DPN. We randomized 30 individuals with DPN (IWGDF risk category 1 or 2) into either the control group (CG) receiving the usual care or the intervention group (IG) receiving the usual care plus an internet-based foot–ankle exercise program, fully guided by the Sistema de Orientação ao Pé Diabético (SOPeD; translation: Diabetic Foot Guidance System) three times per week for 12 weeks. We assessed face-to-face clinical and biomechanical outcomes at baseline, 12 weeks, and 24 weeks (follow up). Participants had good adherence to the proposed intervention and it led to only mild adverse events. The IG showed improvements in the ankle and first metatarsophalangeal joint motion after 12 and 24 weeks, changed forefoot load absorption during foot rollover during gait after 24 weeks, reduced foot pain after 12 weeks, and improved foot function after 24 weeks. A 12-week internet-based foot–ankle exercise program using the SOPeD software (version 1.0) has the potential to reduce foot pain, improve foot function, and modify some important foot–ankle kinematic outcomes in people with DPN. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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Review

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12 pages, 736 KiB

Open AccessReview

Adherence and the Diabetic Foot: High Tech Meets High Touch?

by Hadia Srass, J. Karim Ead and David G. Armstrong

Sensors 2023, 23(15), 6898; https://doi.org/10.3390/s23156898 - 3 Aug 2023

Cited by 6 | Viewed by 2491

Abstract

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. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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15 pages, 3111 KiB

Open AccessCase Report

A Multi-Faceted Digital Health Solution for Monitoring and Managing Diabetic Foot Ulcer Risk: A Case Series

by Emily Matijevich, Evan Minty, Emily Bray, Courtney Bachus, Maryam Hajizadeh and Brock Liden

Sensors 2024, 24(9), 2675; https://doi.org/10.3390/s24092675 - 23 Apr 2024

Cited by 1 | Viewed by 1492

Abstract

Introduction: Diabetic foot ulcers (DFU) are a devastating complication of diabetes. There are numerous challenges with preventing diabetic foot complications and barriers to achieving the care processes suggested in established foot care guidelines. Multi-faceted digital health solutions, which combine multimodal sensing, patient-facing biofeedback, and remote patient monitoring (RPM), show promise in improving our ability to understand, prevent, and manage DFUs. Methods: Patients with a history of diabetic plantar foot ulcers were enrolled in a prospective cohort study and equipped with custom sensory insoles to track plantar pressure, plantar temperature, step count, and adherence data. Sensory insole data enabled patient-facing biofeedback to cue active plantar offloading in response to sustained high plantar pressures, and RPM assessments in response to data trends of concern in plantar pressure, plantar temperature, or sensory insole adherence. Three non-consecutive case participants that ultimately presented with pre-ulcerative lesions (a callus and/or erythematous area on the plantar surface of the foot) during the study were selected for this case series. Results: Across three illustrative patients, continuous plantar pressure monitoring demonstrated promise for empowering both the patient and provider with information for data-driven management of pressure offloading treatments. Conclusion: Multi-faceted digital health solutions can naturally enable and reinforce the integrative foot care guidelines. Multi-modal sensing across multiple physiologic domains supports the monitoring of foot health at various stages along the DFU pathogenesis pathway. Furthermore, digital health solutions equipped with remote patient monitoring unlock new opportunities for personalizing treatments, providing periodic self-care reinforcement, and encouraging patient engagement—key tools for improving patient adherence to their diabetic foot care plan. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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20 pages, 1818 KiB

Open AccessPerspective

Preventative Sensor-Based Remote Monitoring of the Diabetic Foot in Clinical Practice

by Evan Minty, Emily Bray, Courtney B. Bachus, Breanne Everett, Karen M. Smith, Emily Matijevich, Maryam Hajizadeh, David G. Armstrong and Brock Liden

Sensors 2023, 23(15), 6712; https://doi.org/10.3390/s23156712 - 27 Jul 2023

Cited by 9 | Viewed by 3752

Abstract

Diabetes and its complications, particularly diabetic foot ulcers (DFUs), pose significant challenges to healthcare systems worldwide. DFUs result in severe consequences such as amputation, increased mortality rates, reduced mobility, and substantial healthcare costs. The majority of DFUs are preventable and treatable through early detection. Sensor-based remote patient monitoring (RPM) has been proposed as a possible solution to overcome limitations, and enhance the effectiveness, of existing foot care best practices. However, there are limited frameworks available on how to approach and act on data collected through sensor-based RPM in DFU prevention. This perspective article offers insights from deploying sensor-based RPM through digital DFU prevention regimens. We summarize the data domains and technical architecture that characterize existing commercially available solutions. We then highlight key elements for effective RPM integration based on these new data domains, including appropriate patient selection and the need for detailed clinical assessments to contextualize sensor data. Guidance on establishing escalation pathways for remotely monitored at-risk patients and the importance of predictive system management is provided. DFU prevention RPM should be integrated into a comprehensive disease management strategy to mitigate foot health concerns, reduce activity-associated risks, and thereby seek to be synergistic with other components of diabetes disease management. This integrated approach has the potential to enhance disease management in diabetes, positively impacting foot health and the healthspan of patients living with diabetes. Full article

(This article belongs to the Special Issue Saving Limbs and Lives-Sensing and Monitoring Technologies for the Diabetic Foot)

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