Chronic wounds are a major global health challenge associated with substantial economic burden and a negative impact on patient quality of life. Real-time analysis of biomarkers like reactive oxygen and nitrogen species could guide treatment, but existing systems lack the capacity required for continuous monitoring. Wound exudate is secreted slowly and has a complex composition, making efficient fluid collection and real-time analysis challenging. To address these issues, we introduce iCares, a wearable device for wound exudate management and continuous in situ analysis of wound biomarkers. iCares contains a flexible nanoengineered sensor array that measures reactive species such as NO, H ₂ O ₂ , and O ₂ , along with pH and temperature, providing multiparameter data to inform wound status. The device features pump-free triad microfluidic modules with a superhydrophobic-superhydrophilic Janus membrane, bioinspired wedge channels, and three-dimensional graded micropillars for efficient unidirectional exudate collection, transport, and refreshing. The sensors demonstrated a consistent response and analyte selectivity in vitro and in wound exudate. iCares was designed for rapid scalable manufacturing through advanced printing and laser patterning. Wireless connectivity supported long-term continuous monitoring in wounds. The iCares system real-time monitoring was tested in a murine model of diabetic skin wound during infection and antimicrobial treatment. Clinical wound evaluation was conducted in 20 patients with chronic wounds and in two patients before and after surgery. A machine learning analysis of the multiplexed data successfully classified wounds and healing times, indicating that wound exudate analysis by iCares could offer insight into chronic wound status to aid in treatment decisions.

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.

Background: Lower extremity complications of diabetes represent major health care complications both in terms of cost and impact to quality of life for patients with diabetic peripheral neuropathy. Temperature monitoring has been shown in previous studies to provide a useful signal of inflammation that may indicate the early presence of a foot injury. Objective: In this study, we evaluated the temperature data for patients that presented with a diabetic foot injury while using a sock-based remote temperature monitoring device. Methods: The study abstracted data from patients who were enrolled in a remote temperature monitoring program (2020-2021) using a smart sock (Siren Care). In the study cohort, a total of 5 participants with a diabetes-related lower extremity injury during the study period were identified. In the second comparison cohort, a total of 26 patients met the criteria for monitoring by the same methods but did not present with a diabetes-related podiatric lower extremity injury during the same period. The 15-day temperature differential between 6 defined locations on each foot was the primary outcome measure among subjects who presented with a diagnosed foot injury. Paired t tests were used to compare the differences between the two groups. Results: A significant difference in temperature differential (temperature measured in °F) was observed in the group that presented with a podiatric injury over the course of evaluation versus the comparator group that did not present with a podiatric injury. The average difference from all 6 measured points was 1.4 °F between the injury group (mean 3.6, SD 3.0) and the comparator group (mean 2.2, SD 2.5, t=–71.4, df=39; P<.001). Conclusions: The results of this study suggest temperature monitoring in a sock form factor could be used to predict a developing foot injury. The continuous temperature monitoring system employed has implications for further algorithm development to enable early detection. The study was limited by a nonrandomized, observational design with limited injuries present in the study period. We look forward to further studies that will refine the predictive potential and confirm or refute the current promising data.

Background: Remote patient monitoring (RPM) devices are increasingly being used in caring for patients to reduce risks of complications. Temperature monitoring specifically has been shown in previous studies to provide a useful signal of inflammation that may help prevent foot ulcers. Objective: In this cross-sectional study, we evaluated utilization data for patients who were prescribed smart socks as remote temperature monitoring devices. Methods: This study evaluated data from a patient registry from January to July 2021. The utilization data, which were collected starting from the first full month since patients were prescribed the smart socks, were evaluated along with retention over time, the average time that the socks were worn, and the number of days that the socks were worn per month and per week. Results: A total of 160 patients wore the smart sock RPM device for 22 to 25 days per month on average. The retention rate was 91.9% (147/160) at the end of the 7-month period; a total of 13 patients were lost to follow-up during this period. The average number of days that the socks were worn per week was 5.8. The percentage of patients with a utilization rate of >15 days ranged from 79.7% (106/133) to 91.9% (125/136) each month. Conclusions: This study shows a high level of utilization for a smart sock RPM device and a high compliance rate. A future prospective study on the clinical outcomes after the use of the smart socks may further solidify the idea of conducting temperature monitoring for foot ulcer prevention.

Background: Neuropathic foot ulcers are the leading cause of nontraumatic foot amputations, particularly among patients with diabetes. Traditional methods of monitoring and managing these patients are periodic in-person clinic visits, which are passive and may be insufficient for preventing neuropathic foot ulcers and amputations. Continuous remote temperature monitoring has the potential to capture the critical period before the foot ulcers develop and to improve outcomes by providing real-time data and early interventions. For the first time, the effectiveness of such a strategy to prevent neuropathic foot ulcers and related complications among high-risk patients in a real-world commercial setting is reported. Objective: This study aims to evaluate the effectiveness of a real-world continuous remote temperature monitoring program in preventing neuropathic foot ulcers and amputations in patients with diabetes. Methods: In this retrospective analysis of a real-world continuous remote temperature monitoring program, 115 high-risk patients identified by clinical providers from 15 geographically diverse private podiatry offices were analyzed. Patients received continuous remote monitoring socks as part of the program. The enrollment was based on medical necessity as decided by their managing physician. We evaluated data from up to 2 years before enrollment and up to 3 years during the program. The primary outcome was the rate of wound development. Secondary outcomes included amputation rate, the severity of the foot ulcers, and the number of visits to an outpatient podiatry clinic after enrolling in the program. Results: We observed significantly lower rates of foot ulceration (relative risk reduction [RRR] 0.68; 95% CI 0.52-0.79; number needed to treat [NNT] 5.0; P<.001), less moderate to severe ulcers (RRR 0.86; 95% CI 0.70-0.93; NNT 16.2; P<.001), less amputations (RRR 0.83; 95% CI 0.39-0.95; NNT 41.7; P=.006), and less hospitalizations (RRR 0.63; 95% CI 0.33-0.80; NNT 5.7; P<.002). We found a decrease in outpatient podiatry office visits during the program (RRR 0.31; 95% CI 0.24-0.37; NNT 0.46; P<.001). Conclusions: Our findings suggested that a real-world continuous remote temperature monitoring program was an effective strategy to prevent foot ulcer development and nontraumatic foot amputation among high-risk patients.