In the 2002 multicentre randomised controlled trial (RCT) (n=276) comparing collagen/ORC (n=138) with saline-moistened gauze (n=138) for treatment of DFUs, Veves et al.81 reported that after 12 weeks of treatment, 51 (37%) collagen/ORC-treated DFUs and 39 (28.3%) gauze-treated DFUs achieved complete wound closure (p=0.12).In the subset of DFUs with duration of longer than 6 months, more collagen/ORC-treated DFUs achieved closure: 43/95 (45.3%) vs 29/89 (32.6%); p=056. In this initial RCT, the collagen/ORC dressing had similar efficacy and safety compared with saline-moistened gauze and trended toward significance in DFUs with less than 6-month duration.In the 2007 RCT by Lázaro-Martínez et al.patients with neuropathic DFUs of greater than 6-week duration were randomised to either a collagen/ORC dressing or the ‘treatment specified in the standardized protocol for good wound care’. After 6 weeks, significantly more patients in the collagen/ORC group achieved healing than in the standard care group: 12/19 (63%) vs 3/19 (15%); p