Efficacy and safety of a collagen-alginate topical wound dressing (FIBRACOL Collagen-Alginate Wound Dressing) in the treatment of diabetic foot ulcers was compared with that of regular gauze moistened with normal saline. Seventy-five patients with foot ulcers were assigned randomly in a 2:1 ratio to the collagen-alginate test dressing or the gauze dressing. At the end of the study, the mean percent reduction of the wound area was 80.6% +/- 6% in the collagen-alginate dressing group and 61.1% +/- 26% in the gauze dressing group (p = .4692). Thirty-nine (78%) patients treated with the collagen-alginate dressing achieved > or = 75% wound area reduction, compared with 15 (60%) of gauze-treated patients. Complete healing was achieved in 24 (48%) of the collagen-alginate dressing group and 9 (36%) of the gauze dressing group. Wound size, when averaged over the 8-week period and with the duration of the ulcer taken into account, was reduced significantly in the collagen-alginate dressing group, as compared with the gauze dressing group (df = 1, p = .0049). It is concluded that the collagen-alginate test dressing is as or more effective and safe as the currently used treatment.