The objective of this study was to compare the effectiveness of irremovable total-contact casts (TCC) and custom-made temporary footwear (CTF) to heal neuropathic foot ulcerations in individuals with diabetes. In this prospective clinical trial, 43 patients with plantar ulcer grade 1 or 2 (Wagner scale) were randomized to one of two off-loading modalities: TCC or CTF. Outcomes assessed were wound surface area reduction (cm2) and time to wound healing (days) at 2, 4, 8 and 16 weeks. To evaluate safety, possible side effects were recorded at each follow-up visit. The results showed no significant difference in wound surface area reduction (adjusted for baseline wound surface) at 2, 4, 8 or 16 weeks (adjusted mean difference 0.10 cm2; 95% CI -0.92 to 0.72 at 16 weeks). At 16 weeks, 12 patients had a completely healed ulcer, 6 per group. The median time to healing was shorter for the patients using a cast (52 versus 90 days, p = 0.26). Five patients with TCC and two with CTF developed device-related complications. It was concluded that: (i) the rate of wound healing is not significantly different for patients treated with CTF or TCC. The difference in wound surface area was small and not significant at any time during follow-up; and (ii) the difference in healing time (38 days) may have attained statistical significance if the numbers in these sub-groups (2x6) had been higher. Since there appears to be little difference in effectiveness between both off-loading modalities, further investigation into the benefits of CTF is warranted.

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