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Randomized Controlled Trial
. 2010 Jul;33(7):1419-23.
doi: 10.2337/dc09-1708. Epub 2010 Mar 31.

Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial

Ezio Faglia  1 , Carlo Caravaggi, Giacomo Clerici, Adriana Sganzaroli, Vincenzo Curci, Wanda Vailati, Daniele Simonetti, Francesco Sommalvico
Affiliations
Randomized Controlled Trial

Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial

Ezio Faglia et al. Diabetes Care. 2010 Jul.

Abstract

Objective: 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.

Research design and methods: 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.

Results: 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).

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT01005264.

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Figures

Figure 1
Figure 1
“Stabil-D” device and the “Modus” insole. (A high-quality digital representation of this figure is available in the online issue.)
Figure 2
Figure 2
Ulcer size reduction at study completion. *Wilcoxon test. §Mann-Whitney test.
Figure 3
Figure 3
Kaplan-Meier estimate of complete healing rate at study completion.
See this image and copyright information in PMC

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