Prevention Of Amputation Research Articles

Abstract 4136822: Implementation of a Community-Engaged Amputation Prevention Intervention in Rural Appalachia

Amputation is a devastating complication of diabetes and peripheral artery disease and a marker for health inequity. Implementation Science (IS) and Community Engaged-Research (CenR) allow for real-world adaptation of evidence-based interventions and provide critical frameworks for reproducibility and sustainability. However, few amputation interventions use these approaches. We describe the feasibility and acceptability of an IS and CEnR driven amputation intervention in a high-risk rural community. A Pre-Post mixed methods design was used (Fig 1). Intervention components were mapped to the Social-Ecological Model (Fig 2) and guided by the CFIR. Community and Project Advisory Boards collaborated on needs assessment, mobilizing resources, intervention adaptation, data review and dissemination. A 3-component intervention was implemented in 2 clinics to improve local foot care. Components included diabetic foot exams (DFEs), a multidisciplinary limb preservation team, and a “hot-foot” hotline. Pre-implementation, a retrospective chart review was performed along with focus groups. DFE training was then conducted at each site. After training, a prospective chart review was performed with clinic check-ins for 12 months. Focus groups were held 6- and 12-months post-implementation. Concurrently, monthly multidisciplinary teleconferences were held, and a “hot-foot” phoneline connected providers to specialty nurses. At baseline, 155/224 (69.2%) patients received an annual DFE, 17% had all four exam components, 15.6% had foot abnormalities identified and 3.6% were referred to specialists. At 12-months 212/268 (79.1%) patients received a DFE, 84.7% had all components, 54.9% had abnormalities and 20.1% were referred. All findings were statistically significant. Clinically there was a significant decrease in patients with foot wounds, infection, and foot-related hospitalization/ED visits. There were no changes in amputations. (Table 1) The virtual teleconference completed 12 sessions. The hotline was used once with clinicians reporting they did not need it. We demonstrate successful, sustained implementation of an amputation prevention intervention in a high-risk rural community using IS and CEnR. This approach was crucial for overcoming barriers to intervention implementation in a resource poor environment. Additional research to assess patient experience, understand key components of the intervention and study scalability and clinical effectiveness is planned.

Non-surgical interventions for preventing contralateral tissue loss and amputation in dysvascular patients with a primary major lower limb amputation.

Major lower limb amputation (LLA, above the ankle) is performed for people with intractable pain, life-threatening infections, or non-functional limbs. Of 7500 LLAs carried out in England between 2015 and 2018, the majority of these were performed in dysvascular patients. Dysvascularity is the absence of adequate blood supply to maintain a limb's usual function (ischaemia, usually caused by peripheral arterial disease or diabetes mellitus), ultimately leading to pain and tissue injury (ulcers, gangrene, sometimes referred to as tissue loss). Among those who undergo dysvascular LLA, 5.7% and 11.5% will likely undergo contralateral LLA at one and five years respectively, which is associated with greater disability and lower likelihood of returning to work, increasing the psychological burden to the patient and socioeconomic cost to the patient and health service. While extensive research has been carried out in the management of peripheral arterial disease and the care of diabetic feet, there are no guidelines for practice on prevention of contralateral amputation. To assess the effects of non-surgical interventions versus placebo, no intervention, or other non-surgical interventions on contralateral limb (CLL) tissue loss and amputation in dysvascular patients with a primary major LLA. The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and PEDro databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers until 20 March 2023. We also checked the references of identified studies and contacted study authors and manufacturers of relevant products. We aimed to include all randomised controlled trials (RCTs) and quasi-RCTs (e.g. randomised by birthdate) comparing the effectiveness of a non-surgical intervention with placebo, no intervention, or other non-surgical intervention, in adults with a primary major LLA due to dysvascularity. Interventions could be physical, pharmacological, educational, behavioural, or organisational, and delivered by a healthcare professional or carer. Our critical and important outcomes of interest were as follows. Critical outcomes • Incidence of new localised tissue injury or ulceration (tissue loss) of the CLL, regardless of stage or classification at given time points. • Time to the development of any localised tissue injury or ulceration (tissue loss) of the CLL, regardless of stage or classification. • Incidence of new minor amputation (through the ankle, foot, or toe(s)) of the CLL at given time points. • Time to new minor amputation (through the ankle, foot, or toe(s)) of the CLL. • Incidence of new major amputation (whole limb or partial limb, above the ankle) of the CLL at given time points. • Time to new major amputation (whole limb or partial limb, above the ankle) of the CLL. Important outcomes • Survival (time to death from all causes) at 12 months. • Patient-reported outcome measures of health-related quality of life (HRQoL) using validated scales such as the 12-item Short Form Health Survey (SF-12) and EQ-5D. • Adverse events (e.g. infections in the CLL). • Hospital readmission. We used Cochrane's RoB 1 tool to assess risk of bias in the included study. We were only able to perform a narrative review due to lack of data. We reported risk ratios (RR) with 95% CIs for dichotomous outcomes. We used GRADE to assess the certainty of evidence for each outcome. We found one eligible study, which compared electrostimulation of the gastrocnemius muscle and standard rehabilitation against standard rehabilitation in 50 dysvascular amputees. There was no new incidence of tissue loss reported. The following outcomes were not reported: time to new tissue loss; time to and incidence of minor amputation; HRQoL outcomes; adverse events; and hospital readmissions. Electrostimulation was associated with a three-fold reduction in the incidence of new major amputation of the CLL (RR 0.33, 95% CI 0.04 to 2.99), although time to new major amputation was not reported. There was no difference between groups in 12-month survival (RR 1.0, 95% CI 0.85 to 1.18). We judged the overall certainty of the evidence (GRADE) as very low across all outcomes, with unclear risk of selection and detection bias and high risk of performance bias. Despite the care of the CLL being identified as a key research priority by two separate consensus papers, there is insufficient high-quality evidence to address this priority to date. We found only a single RCT suitable for inclusion, and this study was subject to risk of bias. Contralateral limb outcomes should be recorded in future research on dysvascular amputees. Until better evidence and clearer recommendations are available, this topic is likely to remain a research priority. This Cochrane review had no dedicated funding. Protocol available via DOI 10.1002/14651858.CD013857.

Trajectories of Diabetes-Related Sequelae for Identifying Transition Probabilities, and Optimal Timepoints for Prevention of Ulceration, Infection, and Amputation

To reduce diabetes-related complications and to avoid futile procedures, foot and ankle surgeons need to understand the relative timings of catastrophic events, their incidence, and probabilities of transitions between disease states in diabetes in different patient populations. For this study, we tracked medical events (including an initial diagnosis of diabetes, ulcer, wound care, osteomyelitis, amputation, and reamputation, in order of severity) and the time between each such event in patients with diabetes, stratifying by sex, race, and ethnicity. We found that the longest average duration between the different lower extremity states was a diagnosis of diabetes to the occurrence of ulcer at 1137 days (38 months). The average durations of amputation to reamputation, osteomyelitis, wound care, and ulcer were 18, 49, 23, and 18 days, respectively. The length of each disease transition for females was greater, while those of the Hispanic population were shorter than in the total cohort. This knowledge may permit surgeons to time and tailor treatments to their patients, and help patients to address, delay, or avoid complications.

Effectiveness of a Glyceryl Trinitrate (GTN) Patch in Preventing Amputation, Improving Pain Control and Reducing the Size of Tissue Loss for a Patient With Critical Limb-Threatening Ischaemia (CLTI).

Background Foot ulcer is a common complication of poorly controlled diabetes and peripheral vascular disease (PVD). The current standard of treatment for diabetic foot ulcers includes the management of underlying risk factors, wound debridement, use of antibiotics for infection, off-loading with cast, and revascularisation surgery. The glyceryl trinitrate (GTN) patch is currently off-licence in treating PVD or diabetic foot ulcers. This study aims to evaluate the effectiveness of the GTN patch in preventing amputation, improving pain control, and reducing the size of tissue loss (ulcer/gangrene) or localised ischaemic area. Method This is a pilot study of 30 patients who were started on the GTN patchfrom February 2020 to October 2021. Inclusion criteria were patients who have critical limb-threatening ischaemia (CLTI) and with no viable options or are at high risk for revascularisation, both endovascular and open surgery. Patients who were on a GTN patch for less than six weeks at the time of data collection or had unclear outcomes were excluded. The outcomes were retrospectively collected on prevention of amputation, improvement in pain control, and reduction in tissue loss (the size of ulcer/gangrene) or localised ischaemic area with the use of a GTN patch. The binomial test was used to compare the observed outcome of the GTN patch and the expected outcome, which was assumed to be 50% in this study. Results Ninety-three per cent (93%) of the patients who had GTN patches successfully avoided amputation (p<0.0001). Eighty-four per cent (84%) of patients reported better pain control (p=0.0022) and improvement in the size of ulcer/gangrene/localised ischaemic areas (p=0.0005). Conclusion The GTN patch is effective in preventing amputation, improving pain control, and reducing the size of ulcer/gangrene/localised ischaemic areas in patients who have end-stage CLTI and no viable options or who are at high risk for revascularisation surgery.

Successful Implementation of an Amputation Prevention Intervention in a High-risk Rural Community Using Implementation Science, Community-engaged Research, and Mixed Methods

Successful Implementation of an Amputation Prevention Intervention in a High-risk Rural Community Using Implementation Science, Community-engaged Research, and Mixed Methods

Rapid Access From Primary Care to a Multidisciplinary Clinic at Tertiary Care Improves Clinical Outcomes for Patients With Diabetic Foot Ulcers: Results From Diabetic Foot in Primary and Tertiary (DEFINITE) Care's Lower Extremity Amputation Prevention Program (LEAPP) Clinic.

Diabetic Foot in Primary and Tertiary (DEFINITE) Care is an inter-institutional, multidisciplinary team (MDT) program for patients with diabetic foot ulcers (DFU) within a healthcare cluster in Singapore. This is one of our subgroup analyses within DEFINITE Care, assessing clinical outcomes of lower extremity amputation prevention program (LEAPP), a multidisciplinary diabetic foot clinic, and non-LEAPP patients within the program. From June 2020 to June 2022, 2798 patients within the DEFINITE cohort completed a minimum of 12-month follow up. Of these patients, 20.6% were managed by LEAPP, whereas 79.4% were non-LEAPP patients. Patients in the LEAPP cohort were older with co-existing metabolic conditions and complications of diabetes. Using non-LEAPP cohort as the reference group and after adjusting for age, gender, ethnicity, comorbidities, and medications, there was a significantly lower risk of death (odds ratio [OR] 0.60, P = .001) and composite major lower extremity amputation (LEA) or death (OR 0.66, P = .002) among LEAPP patients at 1 year with longer mean days from enrollment to minor LEA, major LEA, and death. The adjusted 1-year healthcare utilization outcomes for LEAPP patients demonstrated an increase in inpatient admissions, primary care polyclinic visits, hospital specialist outpatient clinic (SOC) visits and elective day surgery procedures. Despite the increased in inpatients admissions, cumulative hospital length of stay in LEAPP patients were lower. This subgroup analysis has demonstrated that the MDT approach to caring for patients with DFU in tertiary centers not only improves mortality by 40%, but also delayed the incidence of minor LEA, major LEA, and death.

Impact of a Quality Improvement Initiative on Medical Management of Veterans With Peripheral Artery Disease

Guideline-directed medical therapy (GDMT) for peripheral artery disease (PAD) remains severely underused. Prevention of Amputation in Veterans Everywhere (PAVE) is a screening program designed to prevent or delay major lower extremity amputation. This study aimed to determine whether diagnosis of PAD through the PAVE program improves the prescription of GDMT in veterans with asymptomatic PAD. Patients enrolled into the PAVE program from our institution from 2020 to 2021 were included. Patients with an abnormal ankle-brachial index (ABI), defined as ABI <0.9 or >1.2, were selected for further analysis. Primary outcome was adherence to GDMT, following class I and class IIa recommendations. Secondary outcomes included changes in low-density lipoprotein (LDL), blood pressure, and hemoglobin A1c (HbA1c). A total of 6,313 patients were enrolled into the PAVE program between 2020 and 2021. Of these, 211 had abnormal ABI and were included in our analysis. With enrollment into PAVE, there was significant increase in the prescription of aspirin (74.4% vs 64.9%, p = 0.044) and statins (91.5% vs 82%, p = 0.006). The overall adherence to GDMT significantly increased (56.9% vs 38.9%, p <0.001). The number of patients needed to enroll in PAVE to improve GDMT adherence is 5.6 (95% confidence interval 3.6 to 12.3). Patients enrolled into PAVE program saw significant decreases in HbA1c, with mean decrease of 0.3 (p = 0.012) and a decrease in LDL, with a mean decrease of 6.2 (p = 0.01). In conclusion, enrollment into an amputation prevention program secondarily increased adherence to GDMT, driven by increases in the prescription of statins and aspirin, with resulting decreases in HbA1c and LDL.

Assessing equity in the uptake of remote foot temperature monitoring in a large integrated US healthcare system.

We assessed equity in the uptake of remote foot temperature monitoring (RTM) for amputation prevention throughout a large, integrated US healthcare system between 2019 and 2021, including comparisons across facilities and between patients enrolled and eligible patients not enrolled in RTM focusing on the Reach and Adoption dimensions of the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. To assess whether there was equitable use of RTM across facilities, we examined distributions of patient demographic, geographic, and facility characteristics across facility RTM use categories (e.g., no RTM use, and low, moderate, and high RTM use) among all eligible patients (n = 46,294). Second, to understand whether, among facilities using RTM, there was equitable enrollment of patients in RTM, we compared characteristics of patients enrolled in RTM (n = 1066) relative to a group of eligible patients not enrolled in RTM (n = 27,166) using logistic regression and including all covariates. RTM use increased substantially from an average of 11 patients per month to over 40 patients per month between 2019 and 2021. High-use RTM facilities had higher complexity and a lower ratio of patients per podiatrist but did not have consistent evidence of better footcare process measures. Among facilities offering RTM, enrollment varied by age, was inversely associated with Black race (vs. white), low income, living far from specialty care, and being in the highest quartiles of telehealth use prior to enrollment. Enrollment was positively associated with having osteomyelitis, Charcot foot, a partial foot amputation, BMI≥30 kg/m2, and high outpatient utilization. RTM growth was concentrated in a small number of higher-resourced facilities, with evidence of lower enrollment among those who were Black and lived farther from specialty care. Future studies are needed to identify and address barriers to uptake of new interventions like RTM to prevent exacerbating existing ulceration and amputation disparities.

Risk factors for amputation in diabetic foot ulcers: A retrospective analysis.

Diabetic foot ulcers (DFUs) are chronic, difficult-to-heal wounds with a very high incidence of amputation. For patients with DFUs, prevention of amputation is crucial. However, the risk factors associated with DFU amputation and the extent to which different risk factors increase the risk of amputation are still uncertain. This study intends to provide a clinical basis for early intervention in DFU by retrospectively analysing the risk factors for DFU amputation. A retrospective analysis of 200 patients with DFUs admitted between October 2019 and October 2023 was conducted. Sixty-eight of the 200 underwent amputations. The overall amputation rate was 34%. Multiple logistic regression model showed that neutrophil/lymphocyte ratio (OR = 1.943; 95% CI:1.826-2.139), white blood cell (OR = 1.143; 95% CI:1.034-1.267), C-reactive protein (OR = 1.307; 95% CI:1.113-2.194) and Wagner grading (OR = 2.783; 95% CI: 1.751-4.302) were independent risk factors for amputation, while haemoglobin (OR = 0.742; 95% CI:0.638-0.965) and high density lipoprotein were independent protective factors for amputation (OR = 0.168; 95% CI:0.037-0.716), and further Receiver Operating Characteristic Curve curves showed that they showed high accuracy and were good predictors of amputation of DFUs.

Establishing a Critical Limb Ischemia Outpatient Center: Separating Facts from Myth

Critical Limb Ischemia or chronic limb-threatening ischemia represents the end stage of peripheral artery disease where arterial flow is compromised to the lower extremities and risk of limb loss may become imminent. Revascularization of lower extremities is one of the cornerstones of limb salvage and amputation prevention. Establishing centers of high quality CLI therapy requires creating different foundational pillars in order to be successful. This article discusses critical limb ischemia center creation from the perspective of critical limb ischemia therapists working in an outpatient setting.

Interventional Treatment Options for the Prevention of Amputation in Patients With Lower Extremity Wounds From Peripheral Arterial Disease.

Peripheral arterial disease and related lower extremity wounds are prominent causes of amputation. Revascularization may reduce amputation rates or the amputation margin more distally in patients with peripheral arterial disease who have wounds resulting from critical limb ischemia. This study examined the association of risk factors and intervention types with amputation rates in patients with critical lower extremity arterial disease. A total of 211 patients who underwent peripheral intervention because of foot wound were followed up for 12 months after the intervention. All patients had lower extremity wounds resulting from peripheral arterial disease. The effects of treatment approaches were compared in patients who underwent and did not undergo amputation. Revascularization of the anterior tibial artery reduced the amputation rate by 6.52 times compared with occlusion. Posterior tibial artery revascularization reduced the amputation rate by 49.95 times. In this study of percutaneous intervention methods for prevention of amputation, the most effective option was revascularization of the posterior tibial artery and anterior tibial artery. Considering these results, treatment of critical peripheral arterial disease can be cost-effective and efficient and may shorten procedure time.

Fetal progenitor cells for treatment of chronic limb ischemia.

This study investigated the therapeutic potential of fetal progenitor cells (FPCs) in the treatment of chronic non-healing wounds and ulcers associated with chronic limb ischemia (CLI). The research aimed to elucidate the mechanism of action of FPCs and evaluate their efficacy and safety in CLI patients. The researchers isolated FPCs from aborted human fetal liver, brain, and skin tissues and thoroughly characterized them. The preclinical phase of the study involved assessing the effects of FPCs in a rat model of CLI. Subsequently, a randomized controlled clinical trial was conducted to compare the efficacy of FPCs with standard treatment and autologous bone marrow mononuclear cells in CLI patients. The clinical trial lasted 12 months, with a follow-up period of 24-36 months. The primary outcomes included wound healing, frequency of major and minor amputations, pain reduction, and the incidence of complications. Secondary outcomes involved changes in local hemodynamics and histological, ultrastructural, and immunohistochemical assessments of angiogenesis. In the animal model, FPC treatment significantly enhanced angiogenesis and accelerated healing of ischemic wounds compared to controls. The clinical trial in CLI patients demonstrated that the FPC therapy achieved substantially higher rates of complete wound closure, prevention of major amputation, pain reduction, and improvement in ankle-brachial index compared to control groups. Notably, the study reported no serious adverse events. FPC therapy exhibited remarkable efficacy in promoting the healing of ischemic wounds, preventing amputation, and improving symptoms and quality of life in patients with CLI. The proangiogenic and provasculogenic effects of FPCs may be attributed to their ability to secrete specific growth factors. These findings provide new insights into the development of cellular therapeutic angiogenesis as a promising approach for the treatment of peripheral arterial diseases.

Patient perceptions of barriers to attending annual diabetes review and foot assessment in general practice: a qualitative study.

Introduction Regular diabetic foot checks, at least annually, are important for early identification of risk factors and prevention of ulceration and amputation. To ensure this, most general practices in Aotearoa New Zealand (NZ) offer free annual diabetes reviews (ADRs) which include a comprehensive foot evaluation. However, attendance rates at these ADRs are low. Aim To explore patients' perspectives on the barriers to attending ADRs and foot checks. Methods Semi-structured interviews with people with type 2 diabetes who were overdue their ADR (n = 13; 7 women, 6 Māori) from two urban practices were conducted. Interviews were audio recorded and transcribed verbatim and then analysed using an inductive thematic analysis approach. Results We identified three key themes demonstrating barriers to attendance: healthcare-associated factors (suboptimal clinician-patient relationship, not having a consistent general practitioner (GP)); patient-related factors (co-morbid health conditions, issues surrounding identity, and logistical issues); and systemic factors (COVID-19 pandemic, travel distance to the practice, unawareness of available foot care services). Participants' feedback focused on patient-centred approaches for improvements to service delivery, for example using online educational materials, and utilising culturally appropriate models of health including Te Whare Tapa Whā and Whānau Ora approach. Discussion We identified several barriers to attendance, some of which are potentially modifiable. Addressing modifiable barriers and incorporating suggestions made by participants may improve access to the ADR and reduce non-attendance. Further participatory action research could explore these insights in ways that facilitate tino rangatiratanga (self-determination) and palpable action.

Current Status and Principles for the Treatment and Prevention of Diabetic Foot Ulcers in the Cardiovascular Patient Population: A Scientific Statement From the American Heart Association.

Despite the known higher risk of cardiovascular disease in individuals with type 2 diabetes, the pathophysiology and optimal management of diabetic foot ulcers (DFUs), a leading complication associated with diabetes, is complex and continues to evolve. Complications of type 2 diabetes, such as DFUs, are a major cause of morbidity and mortality and the leading cause of major lower extremity amputation in the United States. There has recently been a strong focus on the prevention and early treatment of DFUs, leading to the development of multidisciplinary diabetic wound and amputation prevention clinics across the country. Mounting evidence has shown that, despite these efforts, amputations associated with DFUs continue to increase. Furthermore, due to increasing patient complexity of management secondary to comorbid conditions, such as cardiovascular disease, the management of peripheral artery disease associated with DFUs has become increasingly difficult, and care delivery is often episodic and fragmented. Although structured, process-specific approaches exist at individual institutions for the management of DFUs in the cardiovascular patient population, there is insufficient awareness of these principles in the general medicine communities. Furthermore, there is growing interest in better understanding the mechanistic underpinnings of DFUs to better define personalized medicine to improve outcomes. The goals of this scientific statement are to provide salient background information on the complex pathogenesis and current management of DFUs in cardiovascular patients, to guide therapeutic and preventive strategies and future research directions, and to inform public policy makers on health disparities and other barriers to improving and advancing care in this expanding patient population.

Outcomes of Endovascular Treatment for Critical Limb Threatening Ischemia

INTRODUCTIONCritical limb threatening ischemia (CLTI), particularly in patients with ischemic ulceration has been associated with significant morbidity and mortality. Typically, endovascular therapy has been first-line therapy for our patients, but this strategy has come into question based upon the Best Endovascular Versus Best Surgical Therapy in Patients with Critical Limb Threatening Ischemia (BEST-CLI) trial data. METHODS& RESULTS: For comparative purposes, we evaluated outcomes from 150 CLTI patients with ischemic ulceration treated with endovascular-first therapy. The mean age was 72 years in this pre-dominate male, Caucasian, ambulatory group. The major co-morbidities were smoking history in 49% and diabetes mellitus in 67%. Anatomic scoring, using SVS criteria, revealed only 35.6% had favorable anatomy (GLASS of 0,1) for long-term patency compared to 64.4% of limbs with unfavorable anatomy for long-term patency (GLASS 2,3). Stents were used in 47% of cases. Reintervention occurred in 36% over 24 months follow-up. At 12 and 24 months, the Kaplan-Meier projections for survival was 0.80 (0.73, 0.87) and 0.69 (0.59, 0.79); amputation was 0.69 (0.61, 0.77) and 0.59 (0.46, 0.71); amputation-free survival was 0.56 (0.48, 0.65) and 0.38 (0.27, 0.50), respectively. Amputation was more common in those with reinterventions (p=0.033). Mortality was predicted with ABI <0.40 or >1.30 (p=0.0019) and the presence of infection (p=0.0047). Amputation-free survival was predicted by the presence of any infection (p=0.0001). CONCLUSIONDespite technically successful endovascular treatment, patients who present with CLTI maintain a high-risk for limb loss and mortality. Amputation prevention must vigilantly address infection risk. These data correlate with outcomes from BEST-CLI trial enhancing applicability to patient-centered care.

The Validity and Reliability of the SINBAD Classification System for Diabetic Foot Ulcers.

Diabetic foot ulcers (DFUs) are a serious and costly complication of diabetes mellitus with a global prevalence of 6.3% and cost of £8,800 per unhealed DFU in the National Health Service. The three main types of DFU are neuropathic, ischemic, and neuroischemic, with an estimated prevalence of 35%, 15%, and 50%, respectively. Because 85% of lower-limb amputations in patients with diabetes are preceded by a DFU, the task of reducing the current and future burden of DFUs on an international level is of crucial importance. Classification of a DFU is an important and complex process with many independent variables that influence the wound severity. Correct classification of a DFU is important to prevent deterioration in the short term and lower-limb amputation in the long term. Both the accuracy of the clinician's interpretation of categorical data from a classification model and grasp of contextual risk factors can refine diagnoses. The term SINBAD is an acronym for six independent variables: site, ischemia, neuropathy, bacterial infection, area, and depth. This system uses comprehensive parameters with strict criteria to facilitate quick and accurate clinical decisions to prevent lower-limb amputation. In addition to providing quantitative measurement, SINBAD also spotlights the multifaceted characteristics of DFUs. By evaluating the validity and reliability of the SINBAD classification system, its applicability for the assessment of DFUs and prevention of lower-limb amputation can be better understood.

Investigating Diabetic Foot Pathophysiology and Amputation Prevention Strategies through Behavioral Modification

Diabetic foot complications stem from intricate interactions between macrovascular and microvascular changes, neuropathy, inflammation, immune responses, hyperglycemia, oxidative stress, and infection susceptibility. Macrovascular factors like atherosclerosis lead to tissue ischemia, while microvascular dysfunction worsens perfusion deficits. Neuropathy contributes significantly to such complications, causing sensory loss, motor problems, and autonomic dysfunction. This results in unnoticed injuries, muscle atrophy, deformities, and dry skin, elevating the risk of non-healing wounds and infections. Inflammation and immune responses amplify tissue damage and hinder healing. Chronic hyperglycemia generates advanced glycation end products, stiffening tissues, while oxidative stress exacerbates damage. Mitochondrial dysfunction further compromises cellular energy production, worsening tissue repair challenges. These multifaceted factors collectively contribute to diabetic foot complications. The impact of modifiable behavior factors such as smoking, heavy alcohol consumption, and exercise on the risk of lower extremity amputation (LEA) in diabetic patients is also not to be ignored. Substantial data had identified increased LEA risk from smoking and heavy alcohol intake and reduced risk from regular exercise. The cumulative impact of these behaviors underscores the significance of behavior modification in preventing LEA and enhancing the well-being of diabetic patients. Understanding these mechanisms is vital for developing effective preventive strategies, diagnostics, and treatments, addressing the impact of diabetic foot complications on individuals and healthcare systems.

TCT-270 The MicroStent HEAL Post Market Registry: Interim Results of BTK Revascularization and Major Amputation Prevention

TCT-270 The MicroStent HEAL Post Market Registry: Interim Results of BTK Revascularization and Major Amputation Prevention

Intelligent plantar pressure offloading for the prevention of diabetic foot ulcers and amputations.

The high prevalence of lower extremity ulceration and amputation in people with diabetes is strongly linked to difficulties in achieving and maintaining a reduction of high plantar pressures (PPs) which remains an important risk factor. The effectiveness of current offloading footwear is opposed in part by poor patient adherence to these interventions which have an impact on everyday living activities of patients. Moreover, the offloading devices currently available utilize primarily passive techniques, whereas PP distribution is a dynamically changing process with frequent shifts of high PP areas under different areas of the foot. Thus, there is a need for pressure offloading footwear capable of regularly and autonomously adapting to PPs of people with diabetes. The aim of this article is to summarize the concepts of intelligent pressure offloading footwear under development which will regulate PPs in people with diabetes to prevent and treat diabetic foot ulcers. Our team is creating this intelligent footwear with an auto-contouring insole which will continuously read PPs and adapt its shape in the forefoot and heel regions to redistribute high PP areas. The PP-redistribution process is to be performed consistently while the footwear is being worn. To improve adherence, the footwear is designed to resemble a conventional shoe worn by patients in everyday life. Preliminary pressure offloading and user perceptions assessments in people without and with diabetes, respectively, exhibit encouraging results for the future directions of the footwear. Overall, this intelligent footwear is designed to prevent and treat diabetic foot ulcers while enhancing patient usability for the ultimate prevention of lower limb amputations.

Evaluation of the Effectiveness of Remote Foot Temperature Monitoring for Prevention of Amputation in a Large Integrated Health Care System

OBJECTIVEWe evaluated the effectiveness of remote foot temperature monitoring (RTM) in the Veterans Affairs health care system.RESEARCH DESIGN AND METHODSWe conducted a retrospective cohort study that included 924 eligible patients enrolled in RTM between 2019 and 2021 who were matched up to 3:1 to 2,757 nonenrolled comparison patients. We used conditional Cox regression to estimate adjusted cause-specific hazard ratios (aHRs) and corresponding 95% CIs for lower-extremity amputation (LEA) as the primary outcome and all-cause hospitalization and death as secondary outcomes.RESULTSRTM was not associated with LEA incidence (aHR 0.92, 95% CI 0.62–1.37) or all-cause hospitalization (aHR 0.97, 95% CI 0.82–1.14) but was inversely associated (reduced risk) with death (aHR 0.63, 95% CI 0.49–0.82).CONCLUSIONSThis study does not provide support that RTM reduces the risk of LEA or all-cause hospitalization in individuals with a history of diabetic foot ulcer. Randomized controlled trials can overcome important limitations.