[Preventing high-risk diabetic foot ulceration by a new method of custom-made shoes in high-risk patients. Prospective study]. / Prévention des plaies du pied chez les diabétiques à haut risque par une méthode innovante d'appareillage par podo-orthèses sur mesure. Etude prospective.

BACKGROUND: The efficacy of custom-made shoes to prevent diabetic foot ulcerations is still unsatisfactory and specific conception is lacking. METHOD AND PATIENTS: We conducted a prospective study on 32 consecutive patients with diabetic mellitus, sensitive neuropathy and healed minor amputation of the foot. They were following a prevention program (education, medical consultation every month). They were treated by custom-made shoes in order to obtain a tested and effective load-off area (after trying and modifying a temporary footwear according to a simple qualitative test of the plantar pressure). RESULTS: At 1 year, 9% of patients presented a new foot ulceration and 3% new minor amputations of the foot. The custom-made shoes had very thick multiple layer total-contact soles (mean thickness 25 mm for a forefoot deformity and 40 mm for a mid-foot deformity). CONCLUSION: This new concept of custom-made shoes might be effective in enhancing the prevention of neuropathic ulcerations for high-risk patients. A randomized controlled trial would be needed to establish sound evidence supporting this new approach for therapeutic footwear.