Custom footwear has been introduced as a way to help relieve some of the pressure and reduce ulcers, but reoccurrence of ulcers still happens. Previous research suggests that plantar pressure measurements can guide footwear modifications to improve pressure points in individual patients. The purpose of this study was to compare the effects of pressure-improved custom-made footwear to regular care on the recurrence of ulcers in an 18 month period. Adherence was also evaluated to determine whether it had an effect on outcome.
A total of 171 patients older than 18 with a confirmed diagnosis of T1DM or T2DM, loss of foot sensation, a healed plantar ulcer, and a new prescription for custom shoes were included in this intention-to-treat analysis. Eighty-five were randomly assigned to the offloading-improved custom-made footwear group. In this group, in-shoe plantar measurements were taken to make the shoe better. The remaining 86 people were assigned to the usual care group that involved custom-made footwear without the improvements.
Demographics, diabetes status, foot complication history, and loss of sensation were assessed at baseline. Both groups were assigned to 3 month follow-ups in which shoes were evaluated to measure peak pressure distribution. The custom group with improvements was modified based on the data collected. Adherence was evaluated with the implanted temperature-based monitor in the shoe and with an ankle band that counted steps. Patients were followed for 18 months or until they had an ulcer recurrence. The primary outcome was the percentage of patients with a plantar foot ulcer within the 18 month period.
It was estimated that there would be 30% recurrence in the usual care group and 15% in the custom group with improvements. The results of that data concluded that there was not a significant difference between the groups. A total of 71 patients had a recurrence, 38.8% in the custom improved group and 44.2% in the usual care group. There were fewer complicated ulcers in the improvement group and also lower peak pressures. Adherence was an issue in the custom-improved group; only 25.7% adhered compared to 47.8% in the usual care group. The authors suggested that if adherence was better, the improvements made to the customized shoe could decrease the risk more. Authors recommended making the shoe more fashionable, educating the patient, and developing an alarm to alert patients when shoes are not worn.
Foot disorders, including ulcers are a leading cause of hospitalization and high treatment cost in diabetes patients.
Ulcers are typically caused by increased levels of mechanical pressure on the foot during ambulation.
Custom-made therapeutic footwear is recommended by international guidelines. The improved in-shoe plantar measurements were the modification being researched.
Bus, S. et al. Effect of Custom-Made Footwear on Foot Ulcer Recurrence in Diabetes. Diabetes Care 36:4109-4116, 2013
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