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Background Foot musculoskeletal deficits are seldom addressed by preventive medicine despite their high prevalence in patients with diabetic polyneuropathy. AIM: To investigate the effects of strengthening, stretching, and functional training on foot rollover process during gait. Methods A two-arm parallel-group randomized controlled trial with a blinded assessor was designed. Fifty-five patients diagnosed with diabetic polyneuropathy, 45 to 65 years-old were recruited. Exercises for foot-ankle and gait training were administered twice a week, for 12 weeks, to 26 patients assigned to the intervention group, while 29 patients assigned to control group received recommended standard medical care: pharmacological treatment for diabetes and foot care instructions. Both groups were assessed after 12 weeks, and the intervention group at follow-up (24 weeks). Primary outcomes involved foot rollover changes during gait, including peak pressure (PP). Secondary outcomes involved time-to-peak pressure (TPP) and pressure–time integral (PTI) in six foot-areas, mean center of pressure (COP) velocity, ankle kinematics and kinetics in the sagittal plane, intrinsic and extrinsic muscle function, and functional tests of foot and ankle. Results Even though the intervention group primary outcome (PP) showed a not statistically significant change under the six foot areas, intention-to-treat comparisons yielded softening of heel strike (delayed heel TPP, p=.03), better eccentric control of forefoot contact (decrease in ankle extensor moment, p<.01; increase in function of ankle dorsiflexion, p<.05), earlier lateral forefoot contact with respect to medial forefoot (TPP anticipation, p<.01), and increased participation of hallux (increased PP and PTI, p=.03) and toes (increase in PTI, medium effect size). A slower COP mean velocity (p=.05), and an increase in overall foot and ankle function (p<.05) were also observed. In most cases, the values returned to baseline after the follow-up (p<.05). Conclusions Intervention discreetly changed foot rollover towards a more physiological process, supported by improved plantar pressure distribution and better functional condition of the foot ankle complex. Continuous monitoring of the foot status and patient education are necessary, and can contribute to preserving the integrity of foot muscles and joints impaired by polyneuropathy. Trial registration ClinicalTrials.gov Identifier: NCT01207284 , registered in 20 th September 2010.

Background Digital solutions in healthcare can facilitate and improve care. However, the experiences and the usefulness of using either digital foot examinations or traditional foot examinations need to be evaluated. The aims of the study were to evaluate: 1) The differences in patient experiences, having their foot examined supported by the Clinical Decision Support System as compared with having their foot examined in traditional practice, 2) How healthcare professionals, by using the digital tool, experienced the routine compared with performing the foot examination as in traditional practice. Methods Of a total of 141 patients, 100 patients with diabetes were single-blind digitally randomised to one of two parallel arms: having their foot examined by a healthcare professional using a digital tool ( n  = 47) or having their foot examined as in traditional practice ( n  = 53) at the Department of Prosthetics and Orthotics at Sahlgrenska University Hospital, Gothenburg, Sweden. Patients filled in a modified version of the National Patient Survey and the Orthotics and Prosthetics Users’ Survey at study end. Two healthcare professionals, working at a Department of Prosthetics and Orthotics, answered surveys regarding the interaction between the patient and the certified prosthetist and orthotist. Results Patients, aged 66 ± 13 years, perceived a high level of satisfaction with the service at the department, regardless of the method used. No significant differences between groups were found when evaluated by 27 questions in the National Patient Survey or by the Orthotics and Prosthetics Users’ Survey, with scores of 67.17 ± 12.18 vs. 66.35 ± 16.52 (p = 0.78) for the intervention and control group respectively. For the same patient that healthcare professionals foot examined, the risk class was fully obtained when the risk to develop foot ulcers was assessed by using the digital tool, whereas only 2% of the patients were classified when foot assessed in traditional practice. Conclusions Regardless of the method used for the foot examination, patients perceived a high level of satisfaction with the services at the Department of Prosthetics and Orthotics. All the patients were risk classified in the intervention group. The healthcare professionals found that, by using the Clinical Decision Support System, the foot examination was structured and followed clinical guidelines. Furthermore, the documentation in the electronic health record was thorough, even though further improvements, such as integration with co-existing health record systems, were requested. Trial registration Clinical Trials NCT03088566 , Registered 23 March 2017.

Background Early detection of diabetic foot ulcerations (DFUs) can avoid or delay any progression into more severe stages, which may require limb amputation or lead to infectious sequelae and death. However, frequent clinical screening would be too intrusive and costly, and self-examination may be hampered by concomitant diseases and social disabilities. In addition, it requires professional knowledge and experience using specialized devices. Researchers reported that skin temperature monitoring could reduce the risk of DFUs in high-risk patients. The main research objects in this field are effective and convenient means of temperature measurement, accurate and reasonable early warning mechanisms, and timely and appropriate interventions. This trial aims to investigate the effectiveness of daily home-based foot temperature measurements in the prevention of DFUs with the aid of intelligent sensor-equipped insoles combined with photo documentation. Methods/Design In this open-label, prospective, randomized, 24-month trial, 300 patients with diabetes mellitus (type 1 or 2) and severe diabetic peripheral neuropathy (vibration sensation ≤ 4/8), aged 18–85 years, will be recruited and assigned to control and intervention groups in a ratio of 1:1. Main inclusion criteria to be eligible for study participation encompass in particular risk group 2 or 3 for the development of DFUs using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Feet [IWGDF]) and the ability to use a mobile phone. Interventions Participants in both groups will receive education about regular foot care at the beginning of the study (visit 0). In the intervention group, every patient will receive a pair of slippers with the inserted sensor-equipped insole as well as a smartphone with the corresponding smartphone application (Smart Prevent Diabetic Feet Application). The insole is a tool that records the temperature variabilities of the plantar foot. Patients will measure their foot temperature twice a day at home with a time interval > 4 h during the entire course of the study (24 months). The measured data will be initially analyzed and visualized, and further transferred to a remote server that allows the physician to perform specific interpretations. In case of temperature differences > 1.5 °C between left and right corresponding sites lasting > 32 h (assigned alarm level 4), the physician will start an intervention phase, which requires the patient to reduce daily activities and relax his feet for five days. At the same time, photo documentation is encouraged to be performed by the patient. Possibly, additional visits to a private doctor or clinical examinations will be arranged for the patient during this intervention period. Outcomes: The primary outcome is foot ulceration, evaluated by a physician, and occurring at any point during the study. Discussion This study addresses principal aspects in the prevention of DFUs. First, the sensor-equipped insole will be evaluated for daily performance in home-based measurements of foot temperatures. Second, a telemedicine structure is tested that evaluates sensor data automatically and proposes suitable intervention measures under the supervision of a physician. Third, predictive models for DFUs will be built using the collected sensor data allowing for interpretations, which in the future may support medical care providers. Trial registration German Clinical Trials Register (DRKS), DRKS00013798 . Registered on 18 January 2018.

PurposeComparison of hemodynamic profiles and pain scores in diabetic patients undergoing diabetic foot surgery receiving peripheral nerve block (PNB) or spinal anesthesia [subarachnoid block (SAB)].MethodsThis was a prospective, randomised controlled trial. We recruited diabetic patients aged > 18 years, American Society of Anesthesiologists class II–III, who were scheduled for unilateral diabetic foot surgery below the knee. All patients were assessed for autonomic dysfunction using the Survey of Autonomic Symptoms score. Participants were randomly assigned to receive either PNB or SAB for the surgery. Hemodynamic data, including usage of vasopressors, were recorded at 5-min intervals for up to 1 h after the induction of anesthesia. Pain scores were recorded postoperatively, and follow-up was done via telephone 6 months later.ResultsCompared to the PNB group, the SAB group had a larger number of patients with significant hypotension (14 vs. 1; p = 0.001) and more patients who required vasopressor boluses (6 vs. 0 patients). Compared to SAB group, the patients in the PNB group had a longer postoperative pain-free duration (9 vs. 4.54 h; p = 0.002) and lower pain scores 1 day after surgery (3.63 vs. 4.69; p = 0.01).ConclusionPeripheral nerve block should be considered, whenever possible, as the first option of anesthesia for lower limb surgery in diabetic patients as it provides hemodynamic stability and superior postoperative pain control compared to SAB.Trial registrationClinical trial registry: ClinicalTrials.gov. ID NCT02727348.

Background Home monitoring of foot temperatures in high-risk diabetes patients proves to be a promising approach for early recognition and treatment of pre-signs of ulceration, and thereby ulcer prevention. Despite previous studies demonstrating its efficacy, it is currently not widely applied in (Dutch) health care. Methods In a multicenter, outcome-assessor-blinded, randomized controlled trial, 304 patients with diabetes mellitus types I or II, loss of protective sensation based on peripheral neuropathy, and a history of foot ulceration in the preceding 4 years or a diagnosis of Charcot neuro-osteoarthropathy will be included. Enhanced therapy will consist of usual care and additional at-home daily measurement of foot temperatures at six to eight predefined locations on the foot. If a contralateral foot temperature difference of > 2.2 °C is found on two consecutive days, the participant is instructed to contact their podiatrist for further foot diagnosis or treatment, and to reduce ambulatory activity by 50% until temperatures are normalized. Enhanced therapy will be compared to usual care. The primary outcomes are the cost (savings) per patient without a foot ulcer (i.e., cost-effectiveness) and per quality-adjusted life year gained (i.e., cost-utility). The primary clinical outcome in the study is the proportion of patients with foot ulcer recurrence on the plantar foot, apical surfaces of the toes, the interdigital spaces or medial and lateral forefoot surfaces during 18-month follow-up. Discussion Confirmation of the efficacy of at-home foot temperature monitoring in ulcer prevention, together with assessing its usability, cost-effectiveness and cost-utility, could lead to implementation in Dutch health care, and in many settings across the world. Trial registration Netherlands Trial Registration: NTR5403 . Registered on 8 September 2015.

Background Diabetic foot osteomyelitis (DFO) poses a major disease burden. It can generally be treated with long-term antibacterial therapy. International guidelines recommend to base antibacterial therapy choices on percutaneous bone biopsy culture, while in practice, therapy is frequently based on (less invasive) ulcer bed cultures. It is currently unknown if treatment outcomes of DFO differ depending on the chosen diagnostic strategy. Methods The BeBoP trial is a multicentre; randomised controlled; physician-, researcher- and subject-blinded; clinical trial comparing two diagnostic strategies in persons with DFO. Culture-directed antibacterial therapy will be based on either percutaneous bone biopsy culture results (intervention group) or ulcer bed biopsy culture results (comparison group). We will enrol 80 subjects with diabetes mellitus (≥ 18 years) and DFO, and we will use block randomisation stratified per centre to randomise them in a 1:1 allocation. The primary outcome is remission of DFO 12 months after enrolment. The secondary outcomes are the time to remission, signs of inflammation or ulceration at the primary location of infection at 6 and 12 months, microbiological and molecular profiles of culture outcomes, surgical interventions including amputation, total antibacterial therapy duration, infection-free survival days, adverse events, quality of life and survival. We will compare the outcomes by intention-to-treat and per-protocol analysis. Discussion We aim to compare clinical remission in persons with DFO treated with antibacterial therapy based on either percutaneous bone biopsy culture results or ulcer bed biopsy culture results. Trial registration Netherlands Trial Register NL 7582 . Registered on 05 March 2019

Elevated plantar foot pressures during gait in diabetic patients with neuropathy have been suggested to result, among other factors, from the distal displacement of sub-metatarsal head (MTH) fat-pad cushions caused by to claw/hammer toe deformity. The purpose of this study was to quantitatively assess these associations. Thirteen neuropathic diabetic subjects with claw/hammer toe deformity, and 13 age- and gender-matched neuropathic diabetic controls without deformity, were examined. Dynamic barefoot plantar pressures were measured with an EMED pressure platform. Peak pressure and force–time integral for each of 11 foot regions were calculated. Degree of toe deformity and the ratio of sub-MTH to sub-phalangeal fat-pad thickness (indicating fat-pad displacement) were measured from sagittal plane magnetic resonance images of the foot. Peak pressures at the MTHs were significantly higher in the patients with toe deformity (mean 626 (SD 260) kPa) when compared with controls (mean 363 (SD 115) kPa, P<0.005). MTH peak pressure was significantly correlated with degree of toe deformity ( r=−0.74) and with fat-pad displacement ( r=−0.71) ( P<0.001). The ratio of force–time integral in the toes and the MTHs (toe-loading index) was significantly lower in the group with deformity. These results show that claw/hammer toe deformity is associated with a distal-to-proximal transfer of load in the forefoot and elevated plantar pressures at the MTHs in neuropathic diabetic patients. Distal displacement of the plantar fat pad is suggested to be the underlying mechanism in this association. These conditions increase the risk for plantar ulceration in these patients.

Background and Objectives: To propose a new classification of diabetic foot syndrome adapted for inclusion in the ICD-10 (the ICD-10 is the 10th revision of the International Statistical Classification of Diseases) and providing more reliable data on the number of clinical cases. Materials and Methods: A randomized controlled trial was performed. A total of 180 patients (36.6%) discharged from the hospital after surgical treatment and 312 patients (63.4%) who applied independently were observed and analysed. All patients had type 2 diabetes and were comparable in gender, age, duration of diabetes, area and nature of the wound defect. Results: We proposed to add the following to the existing ICD-10 and the emerging ICD-11 codes: Edf10.0—insulin-dependent diabetes mellitus with diabetic foot syndrome and Edf11.0—non-insulin-dependent diabetes mellitus with diabetic foot syndrome, where “df” is an acronym for diabetic foot. The new classification designates the seven most frequent areas of the lesion and five degrees of depth of soft tissue lesions. Conclusions: The proposed classification adapted for ICD-10 will enable the standardisation of diagnosis, providing a complete picture of this complication of diabetes mellitus, determining the number of amputations and their validity. Accurate statistics will allow for objective funding and timely preventive measures.

Various foot structures are thought to influence forefoot plantar pressures during walking. High peak plantar pressures (PPP) during walking in people with diabetes mellitus (DM) and peripheral neuropathy (PN) can cause skin breakdown. The question addressed by this study is “What are the primary forefoot structural factors that predict regional PPP during walking in groups of people with and without DM and PN?” Twenty people with DM and PN (mean age 55±9 years, 6 female, 14 male, BMI=33±8) and 20 people without DM, matched for gender, age, and BMI were tested. Measures of foot structure were taken from three-dimensional images constructed from spiral X-ray computed tomography. Peak plantar pressure data were recorded during walking. Hierarchical multiple regression analysis was used to predict regional PPP at the great toe and five metatarsal heads from selected structural and walking variables. Metatarsal phalangeal joint angle (hammer toe deformity) was the most important variable predicting pressure, accounting for 19–45% of the PPP variance at five of the six locations in the DM group. Soft tissue thickness, hallux valgus, and forefoot arthropathy were the most important predictors of PPP in the control group. Combinations of structural and walking variables accounted for 47–71% of the variance in the DM group and 52–83% of the variance of PPP during walking in the control group. These structural variables, especially hammer toe deformity, should be considered in attempts to develop strategies to reduce excessive forefoot PPP that may contribute to skin breakdown or other injury.

Background Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period. Methods/design This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18–80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru. Interventions: participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care. Outcomes: the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study. Discussion This study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability. Trial registration This study is registered in ClinicalTrials.gov: Identifier NCT02373592 .