title: Data-driven directions for effective footwear provision for the high-risk diabetic foot.
abstract: OBJECTIVE
  Custom-made footwear is used to offload the diabetic foot to prevent plantar foot ulcers. This prospective study evaluates the offloading effects of modifying custom-made footwear and aims to provide data-driven directions for the provision of effectively offloading footwear in clinical practice.
  
  
  METHODS
  Eighty-five people with diabetic neuropathy and a recently healed plantar foot ulcer, who participated in a clinical trial on footwear effectiveness, had their custom-made footwear evaluated with in-shoe plantar pressure measurements at three-monthly intervals. Footwear was modified when peak pressure was ≥ 200 kPa. The effect of single and combined footwear modifications on in-shoe peak pressure at these high-pressure target locations was assessed.
  
  
  RESULTS
  All footwear modifications significantly reduced peak pressure at the target locations compared with pre-modification levels (range -6.7% to -24.0%, P < 0.001). The metatarsal heads were most frequently targeted. Repositioning an existing (trans-)metatarsal pad in the shoe insole (-15.9% peak pressure relief), applying local cushioning to the insole (-15.0%) and replacing the insole top cover with Plastazote (-14.2%) were the most effective single modifications. Combining a new Plastazote top cover with a trans-metatarsal bar (-24.0% peak pressure relief) or with local cushioning (-22.0%) were the most effective combined modifications.
  
  
  CONCLUSIONS
  In people with diabetic neuropathy and a recently healed plantar foot ulcer, significant offloading can be achieved at high-risk foot regions by modifying custom-made footwear. These results provide data-driven directions for the design and evaluation of custom-made footwear for high-risk people with diabetes, and essentially mean that each shoe prescribed should incorporate those design features that effectively offload the foot.
authors.affiliation: Department of Rehabilitation Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: M L J
authors.initials: ML
authors.lastname: Arts
authors.affiliation: Department of Rehabilitation Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: de Haart
authors.affiliation: Department of Rehabilitation Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: Waaijman
authors.affiliation: Department of Rehabilitation Medicine, Slotervaart Hospital, Amsterdam, The Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: Dahmen
authors.affiliation: Department of Rehabilitation Medicine, Reinier de Graaf Gasthuis, Delft, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Berendsen
authors.affiliation: Department of Rehabilitation Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Nollet
authors.affiliation: Department of Rehabilitation Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: S A
authors.initials: SA
authors.lastname: Bus
mesh_terms: D000368:Aged; D017719:Diabetic Foot / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy*; D004867:Equipment Design / Q000592:standards; D005260:Female; D005528:Foot / Q000503:physiopathology; D061826:Foot Orthoses / Q000592:standards; D006801:Humans; D008297:Male; D008875:Middle Aged; D011312:Pressure; D012307:Risk Factors; D012775:Shoes; D016896:Treatment Outcome; D016138:Walking; D016474:Weight-Bearing