Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers – A two-year, randomized trial()

BACKGROUND: Special insoles and shoes designed to prevent foot ulcers caused by repetitive high pressures are recommended for patients with diabetes who have any of the following risk factors: neuropathy; peripheral vascular disease; foot deformities; previous ulcers; amputation; and skin pathologies. However, there is a need for increased knowledge regarding: a) differences in the peak pressure (PP) and pressure time integral (PTI) for different types of insoles; and b) the properties of the pressure distribution for insoles used over a period of several months. We present the results of a randomized trial to compare the plantar pressures of three commonly used insoles. OBJECTIVES: The primary objective was to compare the PP and PTI between three types of insoles. The secondary objective was to explore the long-term pattern of peak plantar pressure distribution and variations in specific regions of interest (ROI). The tertiary objective was to investigate the impacts of insole adjustments, how much the insoles were used, and the levels of patient satisfaction. METHODS: In a 2-year trial, 114 patients with type 1 (N = 31) or type 2 (N = 83) diabetes (62 men and 52 women; mean age, 57.7 ± 15.4 years; duration of diabetes, 12.3 ± 11.2 years; neuropathy, 38%), were randomized to be supplied with one of three different insoles. The ethylene vinyl acetate (EVA) insoles were used in outdoor walking shoes. The 35 EVA group (N = 39) received soft custom-made insoles composed of EVA of 35 shore A hardness, the 55 EVA group (N = 37) received custom-made insoles composed of EVA of 55 shore hardness, and the control group (N = 38) received prefabricated insoles composed of a hard core with a top layer of soft 12 shore hardness microfiber. Using F-Scan(®), the in-shoe plantar pressures were measured at seven ROI (hallux, metatarsal head 1, metatarsal head 2, metatarsal head 4, metatarsal head 5, lateral aspect of the mid-foot, heel) on five occasions during the study period. The plantar-pressure variables used were PP (main outcome) and PTI. The plantar patterns of load were explored, satisfaction and usage of the insoles were rated by the participants, and insole adjustments were recorded. RESULTS: A mixed model analysis estimated lower PP values in the heel regions for the 35 EVA and 55 EVA insoles (171 ± 13 and 161 ± 13 kPa, respectively) than for the prefabricated insoles (234 ± 10 kPa) (p < 0.001). Also for some of the other six ROI indications of difference in PP or PTI could be observed. The redistribution of peak plantar pressure for all of the insoles, was stable at the mid-foot, while the proportion of load on the distal area changed during the study period According to the self-reported answers (scale, 0–100), the average usage of the insoles was rated as 79 and satisfaction was rated as 85 (N = 75). Thirty-two percent of the subjects had not received foot care. Fourteen adjustments to insoles were made during the study period, and 86 pairs of insoles were exchanged due to wear, with 49% being exchanged in the 35 EVA group. CONCLUSIONS: Custom-made insoles used in combination with stable walking shoes gave lower pressures at the heel region. The variation makes it difficult to detect a systematic difference in plantar pressure for the 6 ROI, if such a difference indeed exists. The levels of satisfaction and usage for all the insoles tested were high. The insoles maintained their pressure redistribution properties over long periods, and few adjustments were needed.