Development of Cyclic Pressure Offloading Insole for Diabetic Foot Ulcer Prevention.

Introduction. The likelihood of developing a diabetic foot ulcer (DFU) during one's lifetime for individuals with diabetes mellitus is around 19% to 34%. Continuous and repetitive loading on soft tissues are the major causative factors for DFU. This paper introduces an air cell array insole designed for cyclically offloading pressure from plantar regions to reduce repetitive stress and loading on foot. Materials and Methods. The insole comprises an air cell array insole and a pneumatic control unit. The interface pressure was evaluated in static and dynamic conditions at 3 different air cell internal pressures (6.9, 10.3, and 13.8 kPa). Plantar interface pressure was measured using a commercial pressure system, and data were analyzed using paired t test. Average interface pressure and peak pressure (PP) were studied to evaluate the functionality and effectiveness of the insole. Results. The analysis of static pressure data revealed that cyclic offloading significantly (p < .05) reduced PP in 4 tested cells corresponding to big toe, metatarsal heads, and heel areas with the maximum mean difference of 12.9 kPa observed in big toe region. Similarly, dynamic pressure data analysis showed that cyclic offloading significantly (p < .05) reduced PP in these areas, with the highest mean PP reduction of 36.98 kPa in the big toe region. Discussion. Results show the insole's capability to reduce plantar pressure through cyclic offloading. Internal pressure of air cells significantly affects the overall pressure reduction and must be chosen based on the user's weight. Conclusion. Results confirm that the insole with offloading capabilities has the potential to reduce the risk of developing DFUs by alleviating the plantar stress during both static and dynamic conditions.

Smart seat cushion feasibility pilot study: automated interface pressure modulation of individuals with spinal cord Injury.

This study investigates the functionality and feasibility of a novel smart seat cushion system designed for wheelchair users with spinal cord injuries. The cushion, equipped with air cells that serve as both sensors and actuators, was tested on 24 participants for its real-time pressure mapping, automated pressure redistribution, and pressure offloading functions. A commercial pressure mat was concurrently used to validate the cushion's pressure modulation functions. Additionally, the perceived comfort of the cushion was evaluated using General Discomfort Assessment (GDA) and Discomfort Intensity (DIS) scores, which provided insights into participants' overall comfort and discomfort levels. Real-time pressure profiles generated by the cushion resembled commercial pressure mat readings. During tests with individuals with spinal cord injury, the cushion was able to dynamically generate and display the real-time pressure profile of a seated individual with strong precision (correlation to commercial pressure mat: r ranging from 0.76 to 0.88), providing effective input into pressure modulation functions. Pressure redistribution algorithms eliminated peak pressure and reduced the overall pressure at the interface. Pressure offloading algorithms automatically identified the regions with the highest interface pressure and subsequently relieved the pressure from those areas. User feedback showed that the cushion was comfortable after redistribution and offloading. This work demonstrated the feasibility of an advanced smart seat cushion system for wheelchair users with spinal cord injuries. The cushion was capable of redistributing pressure evenly across the seating surface, ensuring user's comfort. Additionally, it identifies and eliminates high-pressure points, further improving comfort and reducing the risk of pressure injuries.

Majority of wheelchair users acquire pressure injuries in their lifetime, where the magnitude and duration of sitting interface pressure are major contributing factors to develop pressure injuries.Compliant cushions and frequent weight shifting can reduce the magnitude and duration of sitting interface pressure; however, the long-term effectiveness of these cushions and the user's lack of compliance to the weight shifting protocols impact their efficacy drastically.An automated cushion system that can reduce the magnitude of the pressure based on the user's current pressure profile and offload pressure from vulnerable areas would improve the effectiveness of the cushion and compensate for poor adherence to weight shifting protocols.Automated solutions will significantly improve the quality of care provided to wheelchair users and reduce the risk of developing pressure injuries.

Clamping soft biologic tissues for uniaxial tensile testing: A brief survey of current methods and development of a novel clamping mechanism.

Biologic tissues are complex materials that come in many forms and perform a variety of functions. They vary widely in composition and mechanical properties, and determination of the mechanical properties of tissues is of interest to those trying to engineer tissues to restore missing function. In performing experiments to characterize the mechanical properties of biologic tissues, there is no single solution to clamping tissues or tissue engineered constructs for mechanical testing. Various clamping techniques have been developed over the past few decades to address the difficulty of imposing appropriate boundary conditions on particular soft tissues during mechanical testing. Two criteria for a successful clamping mechanism are (i) prevention of test specimen slippage, and (ii) prevention of test specimen failure outside the gage region. Herein we present a novel clamping mechanism design developed for the mechanical testing of abdominal wall tissue as an example. This design incorporates pins with serrated clamps to successfully decrease the occurrence of test sample slippage while reducing imposed stress concentrations at the clamping sites. This design was evaluated by performing 40 uniaxial tensile tests on rat abdominal wall muscles using strain rates of 1% per second or 10% per second. Load and displacement data were acquired at the grips. The clamping area on the tissue sample was marked with India ink to track potential slippage of the sample during testing. Ultimate tensile strength and the corresponding stretch were calculated when the maximum load was achieved. With fine-tuning of the torque applied to the clamping grips, the success rate of the tensile tests reached over 90%.