Plantar-pressure based orthoses reduce foot ulcer recurrence
Jan S. Ulbrecht, M.D., from Pennsylvania State University in University Park, and colleagues randomized patients to wear shape- and pressure-based orthoses (experimental; 66 patients) or standard-of-care A5513 orthoses (control; 64 patients). Over 15 months of follow-up, patients were assessed for a composite primary end point of forefoot plantar ulcer or nonulcerative plantar forefoot lesion.
The researchers observed a trend toward the composite primary end point in favor of the experimental orthoses. There was a significant difference in ulcer occurrence (P = 0.007), but no difference in the rate of nonulcerative lesions (P = 0.76). The ulcer prevention benefit of the experimental orthoses was significant (P = 0.003) at 180 days. Over the study period, the hazard ratio was 3.4 for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm.
"We conclude that shape- and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses but they did not significantly reduce nonulcerative lesions," the authors write.
Several authors disclosed financial ties to the orthotic industry.
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