Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.
OBJECTIVE
To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration.


METHODS
Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination. Proportional hazards regression was used for analysis.


RESULTS
There was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3-8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study.


CONCLUSIONS
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.
Department of BioBehavioral Health, Pennsylvania State University, University Park, PADepartment of Medicine, Pennsylvania State University, State College, PAMount Nittany Health System, State College, PADIApedia LLC, State College, PA.
Jan S
JS
Ulbrecht
DIApedia LLC, State College, PA.
Timothy
T
Hurley
Department of Public Health Sciences, Pennsylvania State University, Hershey, PA.
David T
DT
Mauger
DIApedia LLC, State College, PADepartment of Orthopaedics and Sports Medicine, University of Washington, Seattle, WA cavanagh@u.washington.edu.
Peter R
PR
Cavanagh
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003920:Diabetes Mellitus / Q000503:physiopathology; D017719:Diabetic Foot / Q000473:pathology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D005528:Foot; D016523:Foot Ulcer / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009989:Orthotic Devices; D010523:Peripheral Nervous System Diseases / Q000150:complications*; D011312:Pressure; D055502:Secondary Prevention; D012775:Shoes; D016037:Single-Blind Method