Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.
Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.
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DOI：
10.2337/dc13-2956
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发表时间：
2014-07
期刊：
影响因子：
16.2
通讯作者：
Cavanagh PR
中科院分区：
文献类型：
--
作者：
Ulbrecht JS;Hurley T;Mauger DT;Cavanagh PR
目的：评估基于形状和赤足足底压力设计的鞋内矫形器在降低糖尿病、周围神经病变和有类似溃烂病史的人的足底溃烂发生率方面的效果。单盲多中心随机对照试验，受试者随机配戴基于形状和压力的矫形器(试验组，n=66)或护理标准A5513矫形器(对照组，n=)。患者被跟踪15个月，直到研究终点(前足底溃疡或非溃疡性前足底病变)或研究终止。采用比例风险回归进行分析。在整个随访期(P=0.13)中，复合性初级终点(溃疡和非溃疡性病变)有有利于实验矫形器的趋势。这一趋势是由于溃疡发生率的显著差异(P=0.007)，而非溃疡性病变的发生率没有差异(P=0.76)。180d时，与对照组相比，实验矫形器对溃疡的预防作用已经显著(P=0.003)，相对于复合终点，实验矫形器的益处也是显著的(P=0.042)。在研究期间，与试验组相比，对照组发生足底溃疡的风险比为3.4(95%可信区间1.3-8.7)。我们得出的结论是，与目前的标准护理矫形器相比，基于形状和赤足足底压力的矫形器在减少足底溃疡复发方面更有效，但它们并没有显著减少非溃疡性病变。
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. 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. 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. 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.
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影响因子：
3.5
作者：
CAVANAGH, PR;DERR, JA;ORCHARD, TJ
通讯作者：
ORCHARD, TJ
影响因子：
4.3
作者：
Driver, Vickie R.;Fabbi, Matteo;Gibbons, Gary
通讯作者：
Gibbons, Gary
影响因子：
16.2
作者：
Vileikyte, Loretta;Gonzalez, Jeffrey S.;Boulton, Andrew J. M.
通讯作者：
Boulton, Andrew J. M.
影响因子：
16.2
作者：
Pham, H;Harkless, LB;Veves, A
通讯作者：
Veves, A
影响因子：
16.2
作者：
PECORARO, RE;REIBER, GE;BURGESS, EM
通讯作者：
BURGESS, EM