In a randomised, controlled study, we compared the efficacy of Grafix ® , a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0⋅0001). The median time to healing was 42 days in Grafix patients compared with 69⋅5 days in controls (P = 0⋅019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0⋅031) and fewer Grafix patients with wound-related infections (18% versus 36⋅2%, P = 0⋅044). Among the study subjects that healed, ulcers remained closed in 82⋅1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0⋅419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU-related complications. The results of this well-controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy.

Walking quickly may be the greatest cause of falling following a trip in healthy older adults. An anterior body mass carriage, accompanied by back and knee extensor weakness, may also lead to falls following a trip. Deficient stepping responses did not contribute to the falls.

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OBJECTIVE -The purpose of this study was to determine whether custom insoles tailored to contours of the barefoot pressure distribution and shape of a patient's foot can reduce plantar pressures in the metatarsal head (MTH) region to a greater extent than conventional custom insoles.RESEARCH DESIGN AND METHODS -Seventy regions of elevated barefoot pressures (mean peak 834 kPa under MTHs) were identified in 20 subjects with diabetes. Foam box impressions of their feet were sent to three different orthotic supply companies for fabrication of custom insoles. One company was also given plantar pressure data, which were incorporated into the insole design. Measurements of in-shoe plantar pressures were recorded during gait for the three custom insoles in a flexible and a rocker-bottom shoe. Peak pressure and force-time integral were extracted for analysis.RESULTS -In 64 of 70 regions, the shape-plus-pressure-based insole in the flexible shoe achieved superior unloading compared with the two shape-based insoles. On average, peak pressure was reduced by 32 and 21% (both P Յ 0.0001) and force-time integral by 40 and 34% (both P Ͻ 0.0001) compared with the shape-based insoles. At the midfoot, force-time integral was increased by 51 and 33% (both P Ͻ 0.01). Similar trends were found using the rockerbottom shoe.CONCLUSIONS -Compared with insoles based only on shape, the use of foot shape with barefoot plantar pressure measurements in designing custom insoles results in enhanced offloading of high-pressure areas under the forefoot. This offloading was achieved by a greater transfer of load to the midfoot without additional loading of other forefoot structures.

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We propose that the mean value for in-shoe pressures reported in these patients be used as a target in footwear prescription for patients with prior ulcers. Although plantar pressure is only one factor in a multifaceted strategy to prevent ulcer recurrence, the quantitative focus on pressure reduction in footwear is likely to have beneficial effects.

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