Preventing Diabetic Foot Re-Ulceration Through an Innovative Pressure and Temperature Monitoring Clinical Device.

This study compared the outcome of an innovative in-shoe pressure and temperature measuring device as an adjunct to standard clinical care for diabetic foot versus standard clinical care alone. It included 88 participants with Type 2 diabetes mellitus with a history of one or more plantar foot ulceration who were already using prescription orthoses. These were randomly divided into the control group (n = 44, standard care only) and the experimental group (n = 44, standard care plus the innovative device). Both groups were monitored for re-ulceration for one year. Overall, the control group exhibited a higher number of re-ulcerations (n = 14) with 2 amputations in comparison with the experimental group (only 2 ulcerations and no amputations) at the end of the study. In conclusion, this innovative in-shoe pressure and temperature measuring device appears to reduce re-ulcerations by offering objective data for clinical decision making in the management of the diabetic high-risk foot.

Digital Foot Technology in Ulcer Prevention and Reulceration: A Clinical Perspective.

BACKGROUND: Studies have shown that personal and economic reasons determine whether clinicians use diagnostic technology in their routine clinical biomechanical practice. This study aimed to identify the biomechanical management plan of local clinicians in relation to management of the diabetic high-risk foot and to investigate whether diagnostic technology is being used to determine the effectiveness of dispensed prescription orthoses in view of ulcer prevention. METHODS: A mixed-methodologic approach was adopted in this study. A retrospective quantitative study was also conducted to access records of patients attending the biomechanics clinic at a local health biomechanics clinic. Outcomes of interest included the number and percentage of patients attending the biomechanics clinic, source of referral to this clinic, age and gender of patients, clinical diagnosis, management plan, and referral pathway. Following a phenomenologic approach, four experienced clinicians working in the private, primary, and tertiary health sectors were interviewed. Thematic analysis was used to analyze and interpret data. RESULTS: Only low-risk patients living with diabetes mellitus were referred for a comprehensive biomechanical examination; the majority were referred by podiatrists. There was no record of diabetic high-risk patients being referred for a detailed biomechanical assessment within the health service. This study also confirmed that, because of the expenses and laborious work involved when using diagnostic technology to assess foot pressures, interviewed clinicians based their treatment plan and tested the efficiency of dispensed offloading devices on the basis of clinical experience and visual observation only. CONCLUSIONS: Waiting for signs of ulceration can be too late for the high-risk foot. A change in clinical practice is recommended where the integration of diagnostic technology, together with standard care, in view of ulcer prevention is warranted.

Innovative single-sensor, in-shoe pressure and temperature monitoring device: A static laboratory validation study.

BACKGROUND: To perform laboratory static validation of pressures from an innovative, single-sensor pressure and temperature monitoring device for the early detection of complications in the high-risk foot. RESEARCH QUESTION: Can an innovative, newly developed, in-shoe pressure and temperature measuring device, detect and measure the in-shoe peak plantar pressures and skin temperature as accurately as the reference standard? METHODS: A pressure generating rig, the Tekscan™ Equilibration 'bladder calibrator', was used to produce a known force, against the gold standard, FScan™ in-shoe pressure mapping system by Tekscan™ and a newly developed prototype. The F-scan® system was used to record the pressure readings and establish a baseline for the readings recorded utilising the prototype. A total of 20 pressure values were recorded with 100 samples each. RESULTS: Exploratory data analysis was conducted to gain insights and analyse the prototype's behaviour at different pressure points. Pre-processing and data cleaning were also performed to remove any anomalies. Support Vector Regressor with a polynomial kernel and Grid-Search algorithm was used to fit the recorded data curve. The best combination of parameters had a Mean Squared Error of 2.59 and a Root Mean Squared Error of 1.61. A simple linear equation was used to convert raw readings to pressure values. SIGNIFICANCE: The results of this study conclude that the pressure measurements taken with the prototype are congruent to the gold standard, F-scan® in-shoe system. This confirms that the prototype is a valid device that can be used safely as a low-cost alternative to current costly commercial in-shoe pressure mapping devices.

Effectiveness of Iontophoresis in Treating Plantar Hyperhidrosis.

BACKGROUND: The purpose of this study was to evaluate the effectiveness of tap water iontophoresis as a treatment for plantar hyperhidrosis. METHODS: Thirty participants living with idiopathic plantar hyperhidrosis and consented to undergo treatment using iontophoresis were recruited. The Hyperhidrosis Disease Severity Score was used to evaluate the severity of the condition before and after treatment. RESULTS: Tap water iontophoresis was found to be effective in the treatment of plantar hyperhidrosis in the study group (P = .005). CONCLUSIONS: Treatment with iontophoresis led to the reduction of disease severity and improvement of quality of life, and it is a safe, easy-to-use method with minimal side effects. This technique should be considered before the use of systemic or aggressive surgical interventions, which could have potentially more severe side effects.

The Impact of Peripheral Artery Disease (PAD) on Lower Limb Kinematics in Type 2 Diabetes Mellitus.

BACKGROUND: Peripheral artery disease (PAD) and diabetes mellitus are factors known to influence gait characteristics. However, there is a lack of knowledge on the extent to which type 2 diabetes mellitus (T2D) and PAD as comorbidities cause limb and gait complications. AIM: The purpose of this study was to investigate the impact of PAD as a complication of T2D on ankle joint dorsiflexion and knee joint flexion angles using an optoelectronic motion analysis system and to find out whether these alterations are complications secondary to neuropathy or reduced blood perfusion. METHODS: Ninety participants were recruited in this quantitative study which applied a prospective, comparative, non-experimental approach. Participants with T2D and PAD (n = 60), categorized according to the severity of PAD (mild and severe group), were compared with a control group consisting of patients with T2D alone. An optoelectronic motion capture system was used to record mean maximum flexion angles of the knee joint and maximum mean dorsiflexion angles of the ankle joint during gait. RESULTS: 180 limbs were analyzed. Both mild and severe PAD participants exhibited a significant increase in mean maximum ankle joint dorsiflexion angles (p = 0.001) and a significant decrease in mean maximum flexion of the knee joint compared with the control subjects (p = 0.001). CONCLUSIONS: This study shows that T2D and PAD alter ankle joint and knee joint kinematics. This research provides biomechanical understanding of limb and gait alterations in this specific patient population which may contribute to an improved understanding of gait alterations and clinical management. The findings suggest that the reduction in ankle joint dorsiflexion commonly attributed to glycosylation in diabetes may be secondary to neuropathy and not to reduced blood perfusion.

The influence of peripheral arterial disease on lower limb surface myoelectric signals in patients living with type II diabetes mellitus.

BACKGROUND: The aim of this study was to evaluate whether there are any significant differences in muscle activity between individuals living with type II diabetes mellitus (T2DM) and individuals living with T2DM and peripheral arterial disease (PAD), during gait at a self-selected speed. The influence of different stages of PAD on muscle activity during gait was also assessed with the use of surface electromyography (EMG). RESEARCH QUESTION: Does PAD affect lower limb muscle activity during gait in the presence of T2DM? METHODS: This quantitative study involves a prospective, comparative, non-experimental subject design. Ninety participants were divided into three groups namely Group A (thirty participants living with T2DM), Group B(i) (thirty participants living with T2DM and mild PAD) and Group B(ii) (thirty participants living with T2DM and severe PAD). Surface electrode sensors were placed according to SENIAM guidelines, on six main lower limb muscles on both limbs. Muscle activity was recorded using a wireless system, where participants were instructed to walk at a self-selected speed on a 10-m walkway. Average Burst RMS was performed and the amplitude (mV) and the duration of muscle activation (s) was analysed. RESULTS: There was a significant increase in muscle amplitude and duration of activation in the presence of lower limb ischaemia during gait. The largest significant difference (p = <0.05) in EMG amplitude and duration of activation when looking at the twelve muscles in general was found between participants living with T2DM and participants living with T2DM and severe PAD. SIGNIFICANCE: The increase in muscle activity indicates that there are musculoskeletal and biomechanical changes in the lower limb musculature with increasing severity of PAD. Higher muscle exertion demands are required during gait which may result in earlier fatigue. EMG tests would be beneficial for detecting muscle dysfunction objectively and non-invasively in T2DM and PAD.