Neuropsychiatric drugs and a neurophysiological marker as predictors of health-related quality of life in patients with phantom limb pain.

OBJECTIVE: To explore the relationship between sociodemographic, clinical, and neurophysiological variables and health-related quality of life (HR-QOL) of patients with phantom limb pain. METHODS: This is a cross-sectional analysis of a previous clinical trial. Univariate and multivariate linear and logistic regression analyses were used to model the predictors of HR-QOL. We utilized a sequential modeling approach with increasing adjustment levels, controlling for age and sex, and other relevant clinical variables (time since amputation, level of amputation, and pain). HR-QOL was assessed by the SF-36 Health Survey and its eight subdomains. RESULTS: We analyzed baseline data from 92 patients with lower-limb amputations. They were mostly male (63%), 45.2 ± 15.6 years, with a mean time since amputation of 82.7 ± 122.4 months, and an overall SF-36 score of 55.9 ± 21.5. We found an association between intracortical facilitation in the affected hemisphere (ICF), gabapentin usage, and HR-QOL. ICF is a predictor of better HRQOL, whereas gabapentin usage was associated with a poorer HR-QOL, with the main model explaining 13.4% of the variance in the outcome. For the SF-36 subdomains, ICF was also a positive predictor for social functioning, bodily pain, and vitality, while medication usage was associated with lower scores in mental health, general health perception, bodily pain, and vitality. CONCLUSION: We found firsthand two new independent predictors of HR-QOL in individuals with PLP, namely, the neurophysiological metric ICF and gabapentin usage. These results highlight the role of the motor cortex excitability in the HR-QOL and stress the need for treatments that favor the neuroplastic adaptation after amputation, for which ICF may be used as a possible marker.

Validation of Proprietary and Novel Step-counting Algorithms for Individuals Ambulating With a Lower Limb Prosthesis.

OBJECTIVE: To compare the accuracy and reliability of 10 different accelerometer-based step-counting algorithms for individuals with lower limb loss, accounting for different clinical characteristics and real-world activities. DESIGN: Cross-sectional study. SETTING: General community setting (ie, institutional research laboratory and community free-living). PARTICIPANTS: Forty-eight individuals with a lower limb amputation (N=48) wore an ActiGraph (AG) wGT3x-BT accelerometer proximal to the foot of their prosthetic limb during labeled indoor/outdoor activities and community free-living. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Intraclass correlation coefficient (ICC), absolute and root mean square error (RMSE), and Bland Altman plots were used to compare true (manual) step counts to estimated step counts from the proprietary AG Default algorithm and low frequency extension filter, as well as from 8 novel algorithms based on continuous wavelet transforms, fast Fourier transforms (FFTs), and peak detection. RESULTS: All algorithms had excellent agreement with manual step counts (ICC>0.9). The AG Default and FFT algorithms had the highest overall error (RMSE=17.81 and 19.91 steps, respectively), widest limits of agreement, and highest error during outdoor and ramp ambulation. The AG Default algorithm also had among the highest error during indoor ambulation and stairs, while a FFT algorithm had the highest error during stationary tasks. Peak detection algorithms, especially those using pre-set parameters with a trial-specific component, had among the lowest error across all activities (RMSE=4.07-8.99 steps). CONCLUSIONS: Because of its simplicity and accuracy across activities and clinical characteristics, we recommend the peak detection algorithm with set parameters to count steps using a prosthetic-worn AG among individuals with lower limb loss for clinical and research applications.

The Effect of Prosthetic Limb Sophistication and Amputation Level on Self-reported Mobility and Satisfaction With Mobility.

OBJECTIVE: To determine if lower limb prosthesis (LLP) sophistication is associated with patient-reported mobility and/or mobility satisfaction, and if these associations differ by amputation level. DESIGN: Cohort study that identified participants through a large national database and prospectively collected self-reported patient outcomes. SETTING: The Veterans Administration (VA) Corporate Data Warehouse, the National Prosthetics Patient Database, participant mailings, and phone calls. PARTICIPANTS: 347 Veterans who underwent an incident transtibial (TT) or transfemoral (TF) amputation due to diabetes and/or peripheral artery disease and received a qualifying LLP between March 1, 2018, and November 30, 2020. INTERVENTIONS: Basic, intermediate, and advanced prosthesis sophistication was measured by the accurate and reliable PROClass system. MAIN OUTCOME MEASURE: Patient-reported mobility using the advanced mobility subscale of the Locomotor Capabilities Index-5; mobility satisfaction using a 0-10-point Likert scale. RESULTS: Lower limb amputees who received intermediate or advanced prostheses were more likely to achieve advanced mobility than those who received basic prostheses, with intermediate nearing statistical significance at nearly twice the odds (adjusted odds ratio (aOR)=1.8, 95% confidence interval (CI), .98-3.3; P=.06). The association was strongest in TF amputees with over 10 times the odds (aOR=10.2, 95% CI, 1.1-96.8; P=.04). The use of an intermediate sophistication prosthesis relative to a basic prosthesis was significantly associated with mobility satisfaction (adjusted ß coefficient (aß)=.77, 95% CI, .11-1.4; P=.02). A statistically significant association was only observed in those who underwent a TT amputation (aß=.79, 95% CI, .09-1.5; P=.03). CONCLUSIONS: Prosthesis sophistication was not associated with achieving advanced mobility in TT amputees but was associated with greater mobility satisfaction. In contrast, prosthesis sophistication was associated with achieving advanced mobility in TF amputees but was not associated with an increase in mobility satisfaction.

'Leaving the Door Open': Perspectives on Decision-Making for Non-Emergency Diabetes-Related Amputation.

INTRODUCTION: Having a lower extremity amputation is a life-changing decision for people living with a diabetes-related foot ulcer. Although previous research has described both positive and negative lifestyle and function outcomes of diabetes-related amputations, limited research has been conducted on the decision-making processes leading up to the amputation. This study aimed to explore the perspectives of persons, healthcare practitioners and experts (including academics and specialists) on decision-making for people with a diabetes-related foot ulcer who may require a non-emergency amputation. METHODS: A qualitative descriptive study using semi-structured interviews enabled people to share their thought processes when making decisions for amputation. Twenty-six participants were interviewed, including nine people with a diabetes-related foot ulcer or amputation, nine health practitioners and eight experts located across five countries. There were 13 female and 13 male participants. Thematic analysis was used for data analysis. RESULTS: Four themes described the decision-making considerations for amputation: 'Balancing the evidence in decision-making', 'Trust, respect and timing of conversations inform decision-making', 'Tailoring decisions for individual circumstance' and 'Reaching the tipping point in decisions for the future'. Work commitments, functional and lifestyle impacts of amputation, the presence of support networks and clinical wound features formed the evidence for a decision for amputation. CONCLUSION: Understanding quality of life needs ensured that decisions for amputation addressed expectations and lifestyle needs. Living with a diabetes-related foot ulcer presented daily challenges that pushed people to a tipping point, at which amputation was considered to overcome these hardships and enable them to move on to the next chapter of their life. Further research is required to understand how person-centred factors can be better incorporated alongside objective clinical assessments in decisions for amputation. PATIENT OR PUBLIC CONTRIBUTION: People with diabetes-related foot ulcers, health practitioners and experts shared their perspectives on the decision-making process for amputation through one-to-one interviews. Consideration of the person in the context of their life, environment and personal needs alongside the pathological factors is warranted.

Patient satisfaction after lower limb replantation surgery for traumatic amputation - a qualitative study.

BACKGROUND: The majority of published literature clinically assesses surgical outcomes after lower limb replantation for traumatic amputations. However, patients' satisfaction and quality of life may not be accurately measured through rigid scoring using standardized patient reported outcome measures. PURPOSE: The aim of this study was to qualitatively assess patient satisfaction and factors associated with achieving good outcomes after successful lower limb replantation surgery. METHODS: A semi-structured interview was conducted with 12 patients who underwent lower limb replantation surgery following traumatic amputation injuries. The interview focused on the patients' experience and satisfaction throughout their injury, surgical journey, rehabilitation and reintegration into their communities. An inductive and deductive thematic analysis was applied using the recorded transcripts to evaluate the overall satisfaction of the patients after lower limb replantation surgery. RESULTS: The following observations emerged from the structured themes among all the patients interviewed: (1) Family and social support was significantly associated with improved qualities of life and satisfaction after lower limb replantation; (2) Patients were generally satisfied with their outcomes despite limitations in physical capabilities; (3) Satisfaction was associated with acceptance of their cosmetic deformity; (4) Social integration and being able to participate in a meaningful manner was associated with greater satisfaction after recovery. CONCLUSIONS: Patients who undergo lower limb replantation can have a significantly improved quality of life if they have strong social support, are able to contribute in a meaningful manner to their communities after surgery, and are accepting of their cosmetic deficiencies.

Can Early Post-Operative Scoring of Non-Traumatic Amputees Decrease Rates of Revision Surgery?

Background and Objectives: Medical registries evolved from a basic epidemiological data set to further applications allowing deriving decision making. Revision rates after non-traumatic amputation are high and dramatically impact the following rehabilitation of the amputee. Risk scores for revision surgery after non-traumatic lower limb amputation are still missing. The main objective was to create an amputation registry allowing us to determine risk factors for revision surgery after non-traumatic lower-limb amputation and to develop a score for an early detection and decision-making tool for the therapeutic course of patients at risk for non-traumatic lower limb amputation and/or revision surgery. Materials and Methods: Retrospective data analysis was of patients with major amputations lower limbs in a four-year interval at a University Hospital of maximum care. Medical records of 164 patients analysed demographics, comorbidities, and amputation-related factors. Descriptive statistics analysed demographics, prevalence of amputation level and comorbidities of non-traumatic lower limb amputees with and without revision surgery. Correlation analysis identified parameters determining revision surgery. Results: In 4 years, 199 major amputations were performed; 88% were amputated for non-traumatic reasons. A total of 27% of the non-traumatic cohort needed revision surgery. Peripheral vascular disease (PVD) (72%), atherosclerosis (69%), diabetes (42%), arterial hypertension (38%), overweight (BMI > 25), initial gangrene (47%), sepsis (19%), age > 68.2 years and nicotine abuse (17%) were set as relevant within this study and given a non-traumatic amputation score. Correlation analysis revealed delayed wound healing (confidence interval: 64.1% (47.18%; 78.8%)), a hospital length of stay before amputation of longer than 32 days (confidence interval: 32.3 (23.2; 41.3)), and a BKA amputation level (confidence interval: 74.4% (58%; 87%)) as risk factors for revision surgery after non-traumatic amputation. A combined score including all parameters was drafted to identify non-traumatic amputees at risk for revision surgery. Conclusions: Our results describe novel scoring systems for risk assessment for non-traumatic amputations and for revision surgery at non-traumatic amputations. It may be used after further prospective evaluation as an early-warning system for amputated limbs at risk of revision.

Cardiovascular Effectiveness and Safety of Antidiabetic Drugs in Patients with Type 2 Diabetes and Peripheral Artery Disease: Systematic Review.

Peripheral artery disease (PAD) is an atherosclerotic condition commonly complicating type 2 diabetes (T2D), leading to poor quality of life and increased risk of major adverse lower-limb (MALE) and cardiovascular (CV) events (MACE). Therapeutic management of PAD in T2D patients is much more arduous, often due to bilateral, multi-vessel, and distal vascular involvement, in addition to increased systemic polyvascular atherosclerotic burden. On the other hand, the pathophysiological link between PAD and T2D is very complex, involving mechanisms such as endothelial dysfunction and increased subclinical inflammation in addition to chronic hyperglycemia. Therefore, the clinical approach should not ignore vascular protection with the aim of reducing limb and overall CV events besides a mere glucose-lowering effect. However, the choice of the best medications in this setting is challenging due to low-grade evidence or lacking targeted studies in PAD patients. The present review highlighted the strong relationship between T2D and PAD, focusing on the best treatment strategy to reduce CV risk and prevent PAD occurrence and worsening in patients with T2D. The Medline databases were searched for studies including T2D and PAD up to June 2024 and reporting the CV effectiveness and safety of the most used glucose-lowering agents, with no restriction on PAD definition, study design, or country. The main outcomes considered were MACE-including nonfatal acute myocardial infarction, nonfatal stroke, and CV death-and MALE-defined as lower-limb complications, amputations, or need for revascularization. To the best of our current knowledge, GLP-1 receptor agonists and SGLT2 inhibitors represent the best choice to reduce CV risk in T2D and PAD settings, but a personalized approach should be considered. GLP-1 receptor agonists should be preferred in subjects with prevalent atherosclerotic burden and a history of previous MALE, while SGLT2 inhibitors should be used in those with heart failure if overall CV benefits outweigh the risk of lower-limb complications.

[Lower Limb Amputations in Patients with Peripheral Arterial Disease and/or Diabetes in Iceland 2010-2019; revascularisation, comorbidities and risk factors].

INTRODUCTION: No recent studies exist on lower extremity amputations (LLAs) in Iceland. The aim of this study was to investigate LLA incidence in Iceland 2010-2019 and preceding procedures in amputations induced by peripheral arterial disease (PAD) and diabetes mellitus (DM). MATERIAL AND METHODS: Retrospective study on clinical records of all patients (>18 years) who underwent LLA in Iceland's two main hospitals during 2010-2019. Patients were excluded if LLA was performed for reasons other than DM and/or PAD. Symptoms, medication and circulation assessment were recorded from first hospital visit due to symptoms, and prior to the last LLA, respectively. Previous arterial surgeries and amputations were also recorded. RESULTS: A total of 167 patients underwent LLA. Thereof, 134 (77 ± 11 years, 93 men and 41 woman) due to DM and/or PAD. The LLA-rate due to those diseases increased from 4.1/100,000 inhabitants in 2010-2013 to 6.7/100,000 in 2016-2019 (p=0,04). Risk factors were mainly hypertension, 84%, and smoking, 69%. Chronic limb-threatening ischemia induced 71% of first hospital visits. Revascularisations were performed (66% endovascular) in 101 patients. Non-diabetic patients were 52% and had statins less frequently prescribed than DM patients (26:45, p<0.001). CONCLUSION: DM and/or PAD are the leading causes of LLA in Iceland. Amputation rate increased during the period but is low in an international context. Amputation is most often preceded by arterial surgery. DM is present in almost half of cases, similar or less than in most other countries. Opportunities for improved prevention should aim on earlier diagnosis and preventive treatment of non-diabetic individuals with PAD.

Clinical utility of 67 Gallium-SPECT/CT for determining osteotomy indication in patients with lower-limb osteomyelitis.

Standard non-invasive methods for diagnosing and selecting the best treatment for osteomyelitis in patients with multiple chronic conditions remain to be established. We aimed to evaluate the ability of quantitative 67 Ga-citrate single-photon emission computed tomography (67 Ga-SPECT/CT) to determine the indication for either non-surgical treatment or osteotomy in patients with lower-limb osteomyelitis (LLOM) associated with diabetes mellitus and lower-extremity ischemia, based on monitoring of inflammatory activity in bone tissue. This single-centre prospective study conducted from January 2012 to July 2017 included 90 consecutive patients with suspected LLOM. Regions of interest were drawn on SPECT images during quantification of Ga accumulation. Subsequently, the inflammation-to-background ratio (IBR) was calculated by dividing the maximal accumulated lesion number by the mean number for the distal femur bone marrow of the unaffected side. Osteotomy was performed in 28 of 90 patients (31%). The osteotomy rate was higher for patients with IBR >8.4 (71.4%) than for those with IBR ≤8.4 (5.5%) (p < 0.001, sensitivity: 0.89, specificity: 0.84). In the multivariate Cox regression analysis, IBR >8.4 was an independent risk factor for osteotomy (hazard ratio [HR]: 19.0, 95% confident interval [CI]: 5.6-63.9, p < 0.001). Transcutaneous oxygen tension (TcPO2 ) was identified as an independent risk factor for lower-limb amputation (HR: 0.96, 95% CI: 0.92-0.99, p = 0.01). The current results indicate that quantitative 67 Ga-SPECT/CT is useful for distinguishing patients with LLOM likely to require osteotomy.

Continuous relative phases of walking with an articulated passive ankle-foot prosthesis in individuals with a unilateral transfemoral and transtibial amputation: an explorative case-control study.

BACKGROUND: A mechanical ankle-foot prosthesis (Talaris Demonstrator) was developed to improve prosthetic gait in people with a lower-limb amputation. This study aims to evaluate the Talaris Demonstrator (TD) during level walking by mapping coordination patterns based on the sagittal continuous relative phase (CRP). METHODS: Individuals with a unilateral transtibial amputation, transfemoral amputation and able-bodied individuals completed 6 minutes of treadmill walking in consecutive blocks of 2 minutes at self-selected (SS) speed, 75% SS speed and 125% SS speed. Lower extremity kinematics were captured and hip-knee and knee-ankle CRPs were calculated. Statistical non-parametric mapping was applied and statistical significance was set at 0.05. RESULTS: The hip-knee CRP at 75% SS walking speed with the TD was larger in the amputated limb of participants with a transfemoral amputation compared to able-bodied individuals at the beginning and end of the gait cycle (p = 0.009). In people with a transtibial amputation, the knee-ankle CRP at SS and 125% SS walking speeds with the TD were smaller in the amputated limb at the beginning of the gait cycle compared to able-bodied individuals (p = 0.014 and p = 0.014, respectively). Additionally, no significant differences were found between both prostheses. However, visual interpretation indicates a potential advantage of the TD over the individual's current prosthesis. CONCLUSION: This study provides lower-limb coordination patterns in people with a lower-limb amputation and reveals a possible beneficial effect of the TD over the individuals' current prosthesis. Future research should include a well-sampled investigation of the adaptation process combined with the prolonged effects of the TD.

Decreasing national trends in diabetic complications hide regional differences: a prospective population-based study using health care registers in Finland.

Objectives. To examine whether possibilities to improve care among patients with diabetes are reflected in the numbers of cardiovascular complications at national and regional level in Finland. Methods. The study population included all patients with diabetes in Finland since 1964. The incidences of first acute coronary syndrome, ischemic stroke and lower limb amputation were examined for the period from 2010 to 2017. The age- and sex-standardised incidence rates were calculated for the first events. Adjusted Poisson regression mixed models were used to calculate average annual trends and assess regional variation of incidences during the periods 2010 to 2013 and 2014 to 2017 in the university hospital districts (UHDs) and hospital districts (HDs). Results. The nationwide incidence of first acute coronary syndrome decreased among patients with diabetes by 2.7% (95% confidence interval 2.3%; 3.0%), ischemic stroke by 2.0% (1.5%; 2.4%) and major lower limb amputation by 4.6% (3.1%; 5.9%) annually. The sexes differed only in the decrease in acute coronary events. The annual decrease among males was 2.1% (1.6%; 2.6%) and among females was 3.4% (2.8%; 4.0%) (p = .001). Marked variation was observed among UHDs and HDs in the incidences of cardiovascular events and lower limb amputations in patients with diabetes. The variation in annual trends of diabetic complications was most pronounced in acute coronary syndrome among UHDs with an estimated variance of 0.0006 (p = .034). Conclusions. The decrease in the incidence of first cardiovascular events among patients with diabetes continued from 2010 to 2017 in Finland. However, the declining national incidence rates hide regional differences which should be a target for improvement.

The influence of simultaneous pancreas-kidney transplantation on the evolution of diabetic foot lesions and peripheral arterial disease.

PURPOSE: Simultaneous pancreas-kidney transplantation (SPKT) remains the best treatment option in patients with type 1 diabetes and chronic kidney failure. There are only a few studies addressing the potential ischemic deterioration of peripheral arterial disease (PAD) due to blood diverting from the iliac artery to the kidney graft. We aimed to evaluate diabetic foot lesions and PAD evolution in SPKT recipients and investigate if they are more frequent in ipsilateral lower limb of kidney graft. METHODS: We developed a retrospective cohort, including patients submitted to SPKT in our tertiary center, between 2000 and 2017. Diabetic foot lesions and PAD frequencies were compared in the period before and after transplantation. RESULTS: Two hundred and eleven patients were included, 50.2% (n = 106) female, with a median age at transplantation of 35 years (IQR 9). After a median follow-up period of 10 years (IQR 7), patient, kidney, and pancreatic graft survival were 90.5% (n = 191), 83.4% (n = 176), and 74.9% (n = 158), respectively. Before transplant, 2.8% (n = 6) had PAD and 5.3% (n = 11) had history of foot lesions. In post-transplant period, 17.1% (n = 36) patients presented PAD and 25.6% (n = 54) developed diabetic foot ulcers, 47.6% (n = 35) of which in the ipsilateral and 53.3% (n = 40) in the contralateral lower limb of the kidney graft (p = 0.48). Nine patients (4.3%) underwent major lower limb amputation, 3 (30%) ipsilateral and 7 (70%) contralateral to the kidney graft (p = 0.29). CONCLUSIONS: Diabetic foot lesions were not more frequent in the ipsilateral lower limb of the kidney graft, therefore downgrading the 'steal syndrome' role in these patients.

The Effect of Advanced Age on Prosthetic Rehabilitation Functional Outcomes in People With Lower Limb Amputations: A Retrospective Chart Audit of Inpatient Admissions.

OBJECTIVE: To evaluate the effect of age on functional outcomes at discharge from prosthetic rehabilitation. DESIGN: Retrospective chart audit. SETTING: Rehabilitation hospital. PARTICIPANTS: Individuals ≥50 years with a transtibial level lower limb amputation (LLA) and above admitted to the inpatient prosthetic rehabilitation program from 2012 to 2019 (n=504). A secondary analysis included a subset of matched participants (n=156). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The L-Test of Functional Mobility (L-Test), 2-Minute Walk Test (2MWT), 6-Minute Walk Test (6MWT), and Activities-specific Balance Confidence scale. RESULTS: A total of 504 participants (66.7±10.1 years) met the inclusion criteria, 63 participants (84.9±3.7 years) were part of the oldest old group. The sample was stratified into 4 age groups (50-59, 60-69, 70-79, and 80+) for data analysis. The analysis of variances were statistically significant for all outcome measures (P<.001). Post-hoc testing for the L-Test, 2MWT, and 6MWT demonstrated that the oldest old had significantly reduced performance compared with people 50-59 years old (P<.05), but there were no significant differences between the oldest old and the 60-69 [(L-Test, P=.802), (2MWT, P=.570), (6MWT, P=.772)] and 70-79 [(L-Test, P=.148), (2MWT, P=.338), (6MWT, P=.300)] age groups. The oldest old reported significantly lower balance confidence compared with all 3 age groups (P<.05). CONCLUSION: The oldest old achieved similar functional mobility outcomes as people 60-79 years, the most common age group of people with an LLA. Advanced age alone should not disqualify individuals from prosthetic rehabilitation.

The impact of walking on the perception of multichannel electrotactile stimulation in individuals with lower-limb amputation and able-bodied participants.

BACKGROUND: One of the drawbacks of lower-limb prostheses is that they do not provide explicit somatosensory feedback to their users. Electrotactile stimulation is an attractive technology to restore such feedback because it enables compact solutions with multiple stimulation points. This allows stimulating a larger skin area to provide more information concurrently and modulate parameters spatially as well as in amplitude. However, for effective use, electrotactile stimulation needs to be calibrated and it would be convenient to perform this procedure while the subject is seated. However, amplitude and spatial perception can be affected by motion and/or physical coupling between the residual limb and the socket. In the present study, we therefore evaluated and compared the psychometric properties of multichannel electrotactile stimulation applied to the thigh/residual limb during sitting versus walking. METHODS: The comprehensive assessment included the measurement of the sensation and discomfort thresholds (ST & DT), just noticeable difference (JND), number of distinct intervals (NDI), two-point discrimination threshold (2PD), and spatial discrimination performance (SD). The experiment involved 11 able-bodied participants (4 females and 7 males; 29.2 ± 3.8 years), 3 participants with transtibial amputation, and 3 participants with transfemoral amputation. RESULTS: In able-bodied participants, the results were consistent for all the measured parameters, and they indicated that both amplitude and spatial perception became worse during walking. More specifically, ST and DT increased significantly during walking vs. sitting (2.90 ± 0.82 mA vs. 2.00 ± 0.52 mA; p < 0.001 for ST and 7.74 ± 0.84 mA vs. 7.21 ± 1.30 mA; p < 0.05 for DT) and likewise for the JND (22.47 ± 12.21% vs. 11.82 ± 5.07%; p < 0.01), while the NDI became lower (6.46 ± 3.47 vs. 11.27 ± 5.18 intervals; p < 0.01). Regarding spatial perception, 2PD was higher during walking (69.78 ± 17.66 mm vs. 57.85 ± 14.87 mm; p < 0.001), while the performance of SD was significantly lower (56.70 ± 10.02% vs. 64.55 ± 9.44%; p < 0.01). For participants with lower-limb amputation, the ST, DT, and performance in the SD assessment followed the trends observed in the able-bodied population. The results for 2PD and JND were however different and subject-specific. CONCLUSION: The conducted evaluation demonstrates that electrotactile feedback should be calibrated in the conditions in which it will be used (e.g., during walking). The calibration during sitting, while more convenient, might lead to an overly optimistic (or in some cases pessimistic) estimate of sensitivity. In addition, the results underline that calibration is particularly important in people affected by lower-limb loss to capture the substantial variability in the conditions of the residual limb and prosthesis setup. These insights are important for the implementation of artificial sensory feedback in lower-limb prosthetics applications.

A Workflow for Studying the Stump-Socket Interface in Persons with Transtibial Amputation through 3D Thermographic Mapping.

The design and fitting of prosthetic sockets can significantly affect the acceptance of an artificial limb by persons with lower limb amputations. Clinical fitting is typically an iterative process, which requires patients' feedback and professional assessment. When feedback is unreliable due to the patient's physical or psychological conditions, quantitative measures can support decision-making. Specifically, monitoring the skin temperature of the residual limb can provide valuable information regarding unwanted mechanical stresses and reduced vascularization, which can lead to inflammation, skin sores and ulcerations. Multiple 2D images to examine a real-life 3D limb can be cumbersome and might only offer a partial assessment of critical areas. To overcome these issues, we developed a workflow for integrating thermographic information on the 3D scan of a residual limb, with intrinsic reconstruction quality measures. Specifically, workflow allows us to calculate a 3D thermal map of the skin of the stump at rest and after walking, and summarize this information with a single 3D differential map. The workflow was tested on a person with transtibial amputation, with a reconstruction accuracy lower than 3 mm, which is adequate for socket adaptation. We expect the workflow to improve socket acceptance and patients' quality of life.

Differential prognostic burden of cardiovascular disease and lower-limb amputation on the risk of all-cause death in people with long-standing type 1 diabetes.

BACKGROUND: Cardiovascular disease (CVD) and nontraumatic lower-limb amputation (LLA) each results in reduced life expectancy in patients with type 1 diabetes, but the differential burden between these conditions is unknown. We compared the effects of CVD and LLA on the risk of mortality in people with type 1 diabetes. METHODS: We used pooled data from the SURGENE, GENEDIAB, and GENESIS prospective cohorts. Data were divided into: 1/absence of CVD (myocardial infarction and/or stroke) nor LLA, 2/history of CVD alone without LLA, 3/LLA alone without CVD or 4/both conditions at baseline. Participants with baseline history of peripheral artery disease were excluded from groups 1 and 2. The study endpoint was any death occurring during follow-up, regardless of the causes. RESULTS: Among 1169 participants (male 55%, age 40 ± 13 years, diabetes duration 23 ± 11 years), CVD, LLA or both were present at baseline in 49 (4.2%), 62 (5.3%) and 20 (1.7%) subjects, respectively. All-cause death occurred in 304 (26%) participants during 17-year follow-up, corresponding to 18,426 person-years and an incidence rate of 16 (95%CI, 15-18) per 1000 person-years. The risk of death increased in individuals with baseline history of CVD (adjusted HR 2.00 [95% CI 1.34-3.01], p = 0.0008) or LLA (2.26 [1.56-3.28], p < 0.0001), versus no condition, with an additive effect in people with both conditions (5.32 [3.14-9.00], p < 0.0001). No incremental risk of death was observed in people with CVD versus LLA (0.87 [0.54-1.41]). Compared with no condition, CVD and LLA were similarly associated with reduced life expectancy during follow-up: 2.79 (95% CI 1.26-4.32) and 3.38 (1.87-4.88) years, respectively. Combined conditions expose to 7.04 (4.76-9.31) less years of life expectancy (all p < 0.0001). CONCLUSIONS: CVD and LLA conferred a similar burden regarding mortality in type 1 diabetes population. Our findings encourage a careful consideration of people with type 1 diabetes and LLA as usually recommended for those with CVD, in terms of management of risk factors, treatments and prevention.

Diabetes and other vascular risk factors in association with the risk of lower extremity amputation in chronic limb-threatening ischemia: a prospective cohort study.

BACKGROUND: Patients with diabetes are at increased risk of developing chronic limb-threatening ischemia (CLTI) due to peripheral arterial disease, and this often results in lower extremity amputation (LEA). Little is known of the interaction between diabetes and other vascular risk factors in affecting the risk of CLTI. METHODS: We investigated the association of diabetes, and its interaction with hypertension, body mass index (BMI) and smoking, with the risk of LEA due to CLTI in the population-based Singapore Chinese Health Study. Participants were interviewed at recruitment (1993-1998) and 656 incident LEA cases were identified via linkage with nationwide hospital database through 2017. Multivariate-adjusted Cox proportional hazards models were used to compute hazard ratios (HRs) and 95% CIs for the associations. RESULTS: The HR (95% CI) for LEA risk was 13.41 (11.38-15.79) in participants with diabetes compared to their counterparts without diabetes, and the risk increased in a stepwise manner with duration of diabetes (P for trend < 0.0001). Hypertension and increased BMI independently increased LEA risk in those without diabetes but did not increase the risk in those with diabetes (P for interaction with diabetes ≤ 0.0006). Conversely, current smoking conferred a risk increment of about 40% regardless of diabetes status. CONCLUSIONS: Although diabetes conferred more than tenfold increase in risk of LEA, hypertension and increased BMI did not further increase LEA risk among those with diabetes, suggesting a common mechanistic pathway for these risk factors. In contrast, smoking may act via an alternative pathway and thus confer additional risk regardless of diabetes status.

Evaluation of an articulated passive ankle-foot prosthesis.

BACKGROUND: Current ankle prostheses for people with unilateral transtibial amputation (TTA) or transfemoral amputation (TFA) are unable to mimic able-bodied performance during daily activities. A new mechanical ankle-foot prosthesis was developed to further optimise the gait of people with a lower-limb amputation. This study aimed to evaluate the Talaris Demonstrator (TD) during daily activities by means of performance-related, physiological and subjective outcome measures. MATERIALS AND METHODS: Forty-two participants completed a protocol assessing performance and functional mobility with their current prosthesis and the TD. The protocol comprised the L-test, 2 min of stair climbing, 2 min of inclined treadmill walking, 6 min of treadmill walking at 3 different speeds in consecutive blocks of 2 min, and a 3-m Backward Walk test (3mBWT). Heart rate was measured during each task, and oxygen uptake was collected during all tasks except for the L-test and 3mBWT. Time of execution was recorded on the L-test and 3mBWT, and the rate of perceived exertion (score = 6-20), fatigue and comfort (score = 0-100) were assessed after each task. Paired sample t-tests and Wilcoxon Signed-rank tests were performed to compare outcomes between prosthetic devices. Benjamini-Hochberg corrections were applied to control for multiple comparisons with a level of significance set at α = 0.05. RESULTS: Subjects with a TTA (N = 28) were faster with their current prosthesis compared to the TD on the L-test and 3mBWT (p = 0.005). In participants with a TFA (N = 14), we observed a tendency towards a higher heart rate during the L-test and towards increased comfort during inclined walking, with the TD compared to the participants' current prosthetic device (0.05 < p < 0.10). Further, no significant results were observed. CONCLUSION: The Talaris Demonstrator is a novel state-of-the-art passive ankle-foot prosthesis for both people with a TTA and TFA. Subjective measures indicate the added value of this device, while overall task performance and intensity of effort do not differ between the Talaris Demonstrator and the current prosthesis. Further investigations unravelling both acute and more prolonged adaptations will be conducted to evaluate the TD more thoroughly.

Access to primary and secondary health care services for people living with diabetes and lower-limb amputation during the COVID-19 pandemic in Lebanon: a qualitative study.

BACKGROUND: People living with chronic conditions and physical disabilities face many challenges accessing healthcare services. In Lebanon, in 2020, the COVID-19 pandemic and concomitant economic crisis further exacerbated the living conditions of this segment of the population. This study explored the barriers to accessing healthcare services among people living with diabetes and lower-limb amputation during the pandemic. METHODS: We conducted semi-structured, in-depth phone interviews with users of the Physical Rehabilitation Program, offered by the International Committee of the Red Cross. We used a purposive sampling technique to achieve maximum variation. Interviews were audio-recorded, transcribed, translated, and analyzed using thematic analysis following the "codebook" approach. Transcripts were coded and grouped in a matrix that allowed the development of themes and sub-themes inductively and deductively generated. RESULTS: Eight participants (7 males, 1 female) agreed to be interviewed and participated in the study between March and April, 2021. Barriers to healthcare services access were grouped according to five emerging themes: (1) economic barriers, included increasing costs of food, health services and medications, transportation, shortage of medications, and limited income; (2) structural barriers: availability of transportation, physical environment, and service quality and availability; (3) cultural barriers: marginalization due to their physical disabilities; favoritism in service provision; (4) personal barriers: lack of psychosocial support and limited knowledge about services; (5) COVID-19 barriers: fear of getting sick when visiting healthcare facilities, and heightened social isolation due to lockdowns and physical distancing. CONCLUSION: The underlying economic crisis has worsened the conditions of people living with diabetes and lower-limb amputation. The pandemic has made these individuals more vulnerable to external and contextual factors that cannot be addressed only at an individual level. In the absence of a protective legal framework to mitigate inequalities, we provide recommendations for governments and nongovernmental institutions to develop solutions for more equitable access to healthcare for this segment of the population.

[Effect of lower limb amputation level on aortic hemodynamics: a numerical study].

It has been found that the incidence of cardiovascular disease in patients with lower limb amputation is significantly higher than that in normal individuals, but the relationship between lower limb amputation and the episodes of cardiovascular disease has not been studied from the perspective of hemodynamics. In this paper, numerical simulation was used to study the effects of amputation on aortic hemodynamics by changing peripheral impedance and capacitance. The final results showed that after amputation, the aortic blood pressure increased, the time averaged wall shear stress of the infrarenal abdominal aorta decreased and the oscillatory shear index of the left and right sides was asymmetrically distributed, while the time averaged wall shear stress of the iliac artery decreased and the oscillatory shear index increased. The changes above were more significant with the increase of amputation level, which will result in a higher incidence of atherosclerosis and abdominal aortic aneurysm. These findings preliminarily revealed the influence of lower limb amputation on the occurrence of cardiovascular diseases, and provided theoretical guidance for the design of rehabilitation training and the optimization of cardiovascular diseases treatment.