Drug & Device Development

Removable walker cast effective for diabetic plantar ulcer

NEW YORK (Reuters Health) - Diabetic plantar ulcers heal just as well with a removable cast walker as with a nonremovable non-weight-bearing fiberglass cast, Italian researchers report.

The removable cast used in this study - the Stabil-D (Podartis srl, Montebelluna, Italy) -- "reduces the burden for nurses and physicians because these devices are very easy to use..." and non-inferior, coauthor Dr. Giacomo Clerici, of IRCCS Policlinico Multimedica, Milan, told.

Dr. Clerici and his colleagues randomized 48 adult diabetics with non-ischemic, non-infected neuropathic plantar ulcers to 90 days of treatment with a total contact cast (TCC group) or a walker cast (Stabil-D group). The Stabil-D has a specifically designed rigid, boat-shaped, rocker sole.

The primary end point was the decrease in ulcer size, and the secondary end point was the rate of complete healing at the end of the study.

In their June 28th online paper in Diabetes Care, the researchers report that two patients in the TCC group and one in the Stabil-D group did not complete the study, leaving 45 evaluable patients. There were no significant differences in demographic or clinical characteristics between the groups.

Ulcer surface decreased from 1.41 to 0.21 cm2 (p < 0.001) in the TCC group and from 2.18 to 0.45 cm2 (p < 0.001) in the Stabil-D group, with no significant difference between the two treatments (p = 0.72). On average, the TCC and Stabil-D treatments reduced the ulcer surface by 73.6% and 90.0%, respectively (p = 0.321). The time course of the reduction also did not differ between the groups.

Ulcers healed completely in 17 TCC patients (73.9%) and 16 Stabil-D patients (72.7%; p = 0.794). The mean healing time was 35.3 days in the TCC group and 39.7 days in the Stabil-D group (p = 0.708).

The Stabil-D cast cost €130 ($165 US), plus €20 ($25 US) for a plantar foot arch support. The TCC cost €74, or €90 for very obese patients. ($93 or $114 US).

The investigators have another randomized trial underway in which they're comparing three different offloading devices: a removable walker, a non-removable walker, and the TCC. "We would like to confirm or not previous studies about the importance of the removability of the offloading apparatus in wound healing rate and in the healing time," Dr. Clerici said.

The authors acknowledge a contribution from Podartis srl, the manufacturers of the Stabil-D.

Diabetes Care 2010.

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