In-Shoe Pressure Measurements in Diabetic Footwear Practice: Success Rate and Facilitators of and Barriers to Implementation.

We aimed to assess the success rate and facilitators of and the barriers to the implementation of in-shoe plantar pressure measurements in footwear practice for people with diabetes at high risk of foot ulceration. Eleven Dutch footwear practices were partly supported in purchasing a pressure measurement system. Over a 2.5-year period, trained shoe technicians evaluated 1030 people with diabetes (range: 13 to 156 across practices). The implementation success and associated facilitators and barriers were evaluated quantitatively using completed measurement forms and pressure measurement data obtained during four monitoring sessions and qualitatively through semi-structured interviews with technicians. Across the 11 practices, the primary target group (people with diabetes and a healed plantar foot ulcer) represented 25-90% of all the patients measured. The results showed that three practices were successful, five moderately successful, and three not successful. The facilitators included support by the company management board, collaboration with a prescribing physician, measurement sessions separate from the outpatient clinic, and a (dedicated) shoe technician experiencing a learning effect. The barriers included investment costs, usability aspects, and limited awareness among shoe technicians. In-shoe plantar pressure measurements can be implemented to a moderate to large degree in diabetic footwear practice. The barriers to and facilitators of implementation are organizational, logistical, financial, or technical, and the barriers are modifiable, supporting future implementation.

Effect of a carbon reinforcement for maximizing shoe outsole bending stiffness on plantar pressure and walking comfort in people with diabetes at high risk of foot ulceration.

BACKGROUND: Different shoe design features can reduce peak plantar pressure to help prevent foot ulcers in people with diabetes. A carbon reinforcement of the shoe outsole to maximize bending stiffness is commonly applied in footwear practice, but its effect has not been studied to date. RESEARCH QUESTION: What is the effect of a carbon shoe-outsole reinforcement on peak plantar pressure and walking comfort in people with diabetes at high risk of foot ulceration? METHODS: In 24 high-risk people with diabetes, in-shoe regional peak pressures were measured during walking at a comfortable speed in two different shoe conditions: an extra-depth diabetes-specific shoe with a non-reinforced outsole and the same type of shoe with a 3-mm-thick full-length carbon reinforcement of the outsole. The same custom-made insole was worn in both shoe conditions. Walking comfort was assessed using a Visual Analogue Scale (0-10, 10 being highest possible comfort). RESULTS: Significantly lower metatarsal head peak pressures (by a median 10-22 kPa) were found with the reinforced shoe compared to the non-reinforced shoe (p < .001). In >83% of cases with the reinforced shoe and >71% with the non-reinforced shoe metatarsal head peak pressures were <200 kPa. At the hindfoot, peak pressures were significantly higher (by a median 24 kPa) with the reinforced shoe (p = .001). No significant shoe effects were found for the toes. No significant shoe effects were found for walking comfort: median 6.1 for the reinforced shoe versus 5.6 for the non-reinforced shoe. SIGNIFICANCE: Adding a full-length carbon reinforcement to the outsole of a diabetes-specific shoe significantly reduces peak pressures at the metatarsal heads, where ulcers often occur, in high-risk people with diabetes, and this does not occur at the expense of patient-perceived walking comfort.

Optimizing footwear for the diabetic foot: Data-driven custom-made footwear concepts and their effect on pressure relief to prevent diabetic foot ulceration.

AIMS: To assess the effect of data-driven custom-made footwear concepts on plantar pressure relief to prevent diabetic foot ulceration. METHODS: Twenty-four neuropathic diabetic patients at high risk of foot ulceration were measured for in-shoe plantar pressures during walking in four data-driven custom-made footwear conditions, an athletic shoe and an off-the-shelf non-therapeutic shoe. Two evidence-based footwear conditions (Shoe-A; Insole-A) follow a scientific-based design protocol, are handmade, and use in-shoe plantar pressure guided optimization. One evidence-based insole condition (Insole-B) uses a barefoot plantar pressure and 3D foot shape-based computer-assisted design and manufacturing (CADCAM) routine. And one insole condition (Insole-C) uses a barefoot and in-shoe plantar pressure and 3D foot shape-based CADCAM design and optimization routine. Patient satisfaction was scored on walking comfort, shoe fit, weight and appearance. RESULTS: All data-driven footwear conditions significantly reduced metatarsal head peak pressure compared with the non-therapeutic shoe (17-53% relief). Shoe-A and Insole-A showed the lowest metatarsal head peak pressures (mean 112-155 kPa, 90-98% of cases <200 kPa), significantly lower than for Insole-B and Insole-C (mean 119-199 kPa, 52-100% <200 kPa). Patient satisfaction was not significantly different between footwear concepts. CONCLUSIONS: This study proves the offloading efficacy of a scientific-based, handmade, and in-shoe plantar pressure data-driven approach to custom-made footwear design, and advocates its implementation to optimize diabetic footwear for plantar foot ulcer prevention.

Mechanical Noise Improves the Vibration Perception Threshold of the Foot in People With Diabetic Neuropathy.

BACKGROUND: Mechanical noise may improve somatosensation at the dorsal side of the foot, but the effect at the plantar side of the foot, the side most at risk for foot ulceration, is unknown. Moreover, techniques used in research so far have several problems that limit applicability in daily practice. Piezoelectric actuators may provide mechanical noise with better clinical applicability. We assessed the effects of piezoelectric actuators generating mechanical noise on the vibration perception threshold (VPT) at the plantar side of the foot in people with diabetic neuropathy. METHODS: Double-blind within-subjects design in a controlled laboratory setting including participants with diabetic neuropathy (N = 40; 18 male; mean age 69.6 years; mean duration of diabetes 14.1 years; mean BMI 30.5). VPT was measured at three plantar foot locations with and without mechanical noise applied via piezoelectric actuators. RESULTS: Mechanical noise improved VPT at metatarsophalangeal joint (MTP) 1 (left 39.3V vs 43.5V; right 39.0 vs 42.6 V), MTP5 (left 37.5V vs 41.7V; right 34.5V vs 40.8V) and the heel (left 40.0V vs 44.0V; right 39.3V vs 41.0V), all P < .001. CONCLUSIONS: Mechanical noise improves VPT at the plantar side of the foot in people with diabetic neuropathy. This is an important step for further development of insoles using mechanical noise that may have the potential to improve VPT and decrease the risk of foot ulceration.

State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy.

Supported by evidence-based guidelines, custom-made footwear is often prescribed to people with diabetes who are at risk for ulceration. However, these guidelines do not specify the footwear design features, despite available scientific evidence for these features. We aimed to develop a design protocol to support custom-made footwear prescription for people with diabetes and peripheral neuropathy. The population of interest was people with diabetes who are at moderate-to-high risk of developing a foot ulcer, for whom custom-made footwear (shoes and/or insoles) can be prescribed. A group of experts from rehabilitation medicine, orthopaedic shoe technology (pedorthics) and diabetic foot research, reviewed the scientific literature and met during 12 face-to-face meetings to develop a footwear design algorithm and evidence-based pressure-relief algorithm as parts of the protocol. Consensus was reached where evidence was not available. Fourteen domains of foot pathology in combination with loss of protective sensation were specified for the footwear design algorithm and for each domain shoe-specific and insole (orthosis)-specific features were defined. Most insole-related features and some shoe-related features were evidence based, whereas most shoe-related features were consensus based. The pressure-relief algorithm was evidence based using recent footwear trial data and specifically targeted patients with a healed plantar foot ulcer. These footwear design and pressure-relief algorithms are the first of their kind and should facilitate more uniform decision making in the prescription and manufacturing of adequate shoes for moderate-to-high-risk patients, reducing variation in footwear provision and improving clinical outcome in the prevention of diabetic foot ulcers.