Impact of compliance with lifestyle recommendations and medication adherence on 1-year prevention of major cardiovascular events in diabetic patients undergoing partial foot amputation

Funding Acknowledgements Type of funding sources: None. Background Partial foot amputation (PFA) is generally not considered a high-risk surgery. However, 3 years survival rate is less than 50-60%. The purpose of the study was to evaluate the impact of compliance with lifestyle recommendations and medication adherence on 1-year prevention of major cardiovascular events (MACE) in patients with type 2 diabetes mellitus (T2DM) after PFA. Methods In this prospective single-center interventional cohort study, 785 consecutive T2DM patients after PFA were included in the 1-year follow-up. Physical examination and laboratory tests were performed at baseline and every month after PFA for 1 year. Patients were considered as compliant with lifestyle recommendations if they followed a healthy diet, smoking cessation, and at least ≥30 min/day physical exercise. Patients were defined as adherent to medication if they followed ≥80% prescribed medication intake. MACE was defined as a composite endpoint including cardiovascular death, myocardial infarction (MI), stent thrombosis, acute stroke, or unstable arrhythmia. Results During 1-year follow-up MACE occurred in 63/535 patients who were medication adherent compared to 137/249 non-adherent patients (Chi square = 167,2, p < 0,001). Among lifestyle compliant patients, 55/498 had MACE compare with 145/286 non-compliant patients (Chi square = 150.3, p < 0,001). The COX regression analysis was conducted to present the adjusted effect of compliance and adherence to the incidence of MACE (B = 0.989, p < 0.001, and B= 1.096, p < 0.001, respectively) (Table). The potential confounders such as age and previous MI were statistically significant (Table). Gender, smoking, diabetes severity, HbA1c, hypertension, symptomatic coronary artery disease, history of ischemic events, heart revascularization were not statistically significant. Conclusion. Failure to follow lifestyle recommendations in T2DM patients after PFA increases the OR of the incidence of MACE 2.7 fold, non-adherence to medication 3 fold. Our results indicate that optimizing preventive interventions is of outmost importance for patients with diabetes undergoing PFA Cox Regression Results for predictors of Indicator Odds ratio B Standard error P-value Age 1.031 0.031 0.009 0.007 History of myocardial infarction 4.017 1.391 0.184 <0.001 Non-compliance to lifestyle changes 2.688 0.989 0.198 <0.001 Medication non-adherence 2.992 1.096 0.186 <0.001

Biomechanical analysis of stair ascent in persons with Chopart amputation

Background: Compared to walking on level ground, ascending stairs requires a large range of motion not only of the hip and knee joint, but also of the ankle joint. The prosthesis often worn by persons with partial foot amputation largely prevents the ankle motion needed during stair ascent. Objectives: Aim of this study was to assess subjects with a Chopart amputation utilizing a clamshell device during stair ascent to identify potential biomechanical deficits. Study design: Cross-sectional study with reference group. Methods: Six subjects with unilateral Chopart amputation and 17 unimpaired subjects underwent three-dimensional motion analysis while ascending stairs in a step-over-step manner. Results: During weight acceptance, the involved side showed increased external hip-flexing and reduced knee-flexing moments and the sound side a higher ankle power than in the control group. The sound side showed higher external knee-flexing, dorsi-flexing, and hip-adducting moments than the controls during weight acceptance. Conclusion: The mechanism observed on the involved side differs from that in controls, but is comparable to the mechanisms used by subjects with transtibial amputation reported in the literature. However, compensatory movements on the sound side take place at the ankle and knee joint, differing from subjects with more proximal amputations. Clinical relevance This study underpins the importance of adequate foot leverage and ankle function in cases of partial foot amputation, particularly in transfer situations such as stair ascent. If ankle range of motion is adequate, prosthetic/orthotic devices combining shank leverage with a hinged spring mechanism at the ankle may be promising.

A new methodology for design and manufacturing of a customized silicone partial foot prosthesis using indirect additive manufacturing

The production of customized prostheses for the foot and ankle still relies on slow and laborious steps of the traditional plaster molding fabrication techniques. Additive manufacturing techniques where three-dimensional objects can be constructed directly based on the object’s computer-aided-design data in a layerwise manner has opened the door to new opportunities for manufacturing of novel and personalized medical devices. The purpose of the present study was to develop a new methodology for design and manufacturing of a customized silicone partial foot prosthesis via an indirect additive manufacturing process. Furthermore, the biomechanics of gait of a subject with partial foot amputation wearing the custom silicone foot prosthesis manufactured by the indirect additive manufacturing was characterized, in comparison with a matched healthy participant. This study has confirmed the possibility of producing silicone partial foot prosthesis by indirect additive manufacturing procedure. The amputated subject reported total comfort using the custom prosthesis during walking, as well as cosmetic advantages. The prosthesis restored the foot geometry and normalized many of gait characteristics. The findings presented here contribute to introduce a proper understanding of biomechanics of walking after wearing silicone partial foot prosthesis and are useful for prosthetists and rehabilitation therapists when treating patients after partial foot amputation.

Vacuum-assisted closure versus moist dressings in the treatment of diabetic wound ulcers after partial foot amputation: A retrospective analysis in 65 patients

Purpose: Changes in weight-bearing patterns after partial foot amputations may lead to new localized high-pressure points and keratosis due to ulcerations in patients with neuropathies and hypovascular limbs. As a result, diabetic foot ulcers (DFUs) after partial foot amputations are very complex. The aim of this study was to compare the effectiveness of vacuum-assisted closure (VAC) therapy with conventional moist wound dressings in the treatment of diabetic wound ulcers after partial foot amputations. Methods: Sixty-five diabetic patients with a DFU, who had previously undergone partial foot amputation surgery, were assigned to treatment with VAC (group A: 31 patients) or conventional wound moist dressing (group B: 34 patients). The final results were considered as failed treatment if reamputation was required. Conversely, reaching 90% of wound granulation was considered to be a successful endpoint. Results: The average time to reach 90% granulation tissue was significantly lower in group A (7.8 ± 1.2 weeks vs. 11.1 ± 1.2 weeks; p < 0.001). However, there was no significant difference regarding the reamputation requirements; 38.7% (12 patients) in group A and 41.2% (14 patients) in group B, ( p = 0.839). Conclusion: The results of this study allowed us to conclude that VAC therapy system appears to be an effective treatment for patients with complex DFUs who had previously undergone partial foot amputation.

Development of shared decision-making resources to help inform difficult healthcare decisions: An example focused on dysvascular partial foot and transtibial amputations

Background: Shared decision making is a consultative process designed to encourage patient participation in decision making by providing accurate information about the treatment options and supporting deliberation with the clinicians about treatment options. The process can be supported by resources such as decision aids and discussion guides designed to inform and facilitate often difficult conversations. As this process increases in use, there is opportunity to raise awareness of shared decision making and the international standards used to guide the development of quality resources for use in areas of prosthetic/orthotic care. Objectives: To describe the process used to develop shared decision-making resources, using an illustrative example focused on decisions about the level of dysvascular partial foot amputation or transtibial amputation. Development process: The International Patient Decision Aid Standards were used to guide the development of the decision aid and discussion guide focused on decisions about the level of dysvascular partial foot amputation or transtibial amputation. Examples from these shared decision-making resources help illuminate the stages of development including scoping and design, research synthesis, iterative development of a prototype, and preliminary testing with patients and clinicians not involved in the development process. Conclusion: Lessons learnt through the process, such as using the International Patient Decision Aid Standards checklist and development guidelines, may help inform others wanting to develop similar shared decision-making resources given the applicability of shared decision making to many areas of prosthetic-/orthotic-related practice. Clinical relevance Shared decision making is a process designed to guide conversations that help patients make an informed decision about their healthcare. Raising awareness of shared decision making and the international standards for development of high-quality decision aids and discussion guides is important as the approach is introduced in prosthetic-/orthotic-related practice.