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Diabetes Care. 2014 Jul;37(7):1982-9. doi: 10.2337/dc13-2956. Epub 2014 Apr 23.

Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.

Author information

1
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.
2
DIApedia LLC, State College, PA.
3
Department of Public Health Sciences, Pennsylvania State University, Hershey, PA.
4
DIApedia LLC, State College, PADepartment of Orthopaedics and Sports Medicine, University of Washington, Seattle, WA cavanagh@u.washington.edu.

Abstract

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.

RESEARCH DESIGN AND 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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00803608.

PMID:
24760263
PMCID:
PMC4067390
DOI:
10.2337/dc13-2956
[Indexed for MEDLINE]
Free PMC Article
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