Diabetic Foot Center, Istituto di Ricovero e Cura a Carattere Scientifico Multimedica, Sesto San Giovanni, Milan, Italy.
Diabetes Care. 2010 Jul;33(7):1419-23. doi: 10.2337/dc09-1708. Epub 2010 Mar 31.
To evaluate the efficacy of a removable cast walker compared with that of a nonremovable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer.
Forty-five adult diabetic patients with nonischemic, noninfected neuropathic plantar ulcer were randomly assigned for treatment with a nonremovable fiberglass off-bearing cast (total contact cast [TCC] group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.
A total of 48 patients were screened; however, 2 patients in the TCC group and 1 patient in the Stabil-D group did not complete the study and were considered dropouts. There were no significant differences in demographic and clinic characteristics of the 45 patients completing the study. Ulcer surface decreased from 1.41 to 0.21 cm(2) (P < 0.001) in the TCC group and from 2.18 to 0.45 cm(2) (P < 0.001) in the Stabil-D group, with no significant differences between groups (P = 0.722). Seventeen patients (73.9%) in the TCC group and 16 patients (72.7%) in the Stabil-D group achieved healing (P = 0.794). Average healing time was 35.3 +/- 3.1 and 39.7 +/- 4.2 days in the TCC and Stabil-D group, respectively (P = 0.708).
The Stabil-D cast walker, although removable, was equivalent in efficacy to the TCC in terms of ulcer size reduction and total healing rate. The easier use of Stabil-D may help increase the use of off-loading devices in the management of plantar neuropathic diabetic foot ulcers.
评估可移动支具式步行靴与不可移动玻璃纤维免荷靴在治疗糖尿病足底溃疡中的疗效。
45 例非缺血性、非感染性神经病变性足底溃疡的成年糖尿病患者被随机分为不可移动玻璃纤维免荷靴(全接触靴[TCC]组)或支具式步行靴(Stabil-D 组)治疗。治疗持续 90 天。治疗后评估溃疡面积减少百分比和总愈合率。
共筛选出 48 例患者,但 TCC 组有 2 例患者和 Stabil-D 组有 1 例患者未完成研究,被视为脱落。完成研究的 45 例患者的人口统计学和临床特征无显著差异。TCC 组溃疡面积从 1.41cm2减少至 0.21cm2(P<0.001),Stabil-D 组从 2.18cm2减少至 0.45cm2(P<0.001),两组间无显著差异(P=0.722)。TCC 组 17 例(73.9%)患者和 Stabil-D 组 16 例(72.7%)患者愈合(P=0.794)。TCC 组和 Stabil-D 组的平均愈合时间分别为 35.3±3.1 和 39.7±4.2 天(P=0.708)。
Stabil-D 支具式步行靴虽然可移动,但在溃疡面积缩小和总愈合率方面与 TCC 疗效相当。Stabil-D 更易用,可能有助于增加在管理糖尿病足底神经病变性溃疡中使用免荷装置。