[Randomized comparative trial of a collagen/oxidized regenerated cellulose dressing in the treatment of neuropathic diabetic foot ulcers]

Abstract

Introduction: Diabetic foot is a complication of diabetes mellitus that manifests with the development of ulcers that frequently precede amputation. Several studies have verified that the environment of the diabetic neuropathic foot ulcer contains a high concentration of metalloproteinases. The aim of the present study was to evaluate the efficacy of a protease-modulating dressing in the treatment of neuropathic diabetic foot ulcers.

Material and method: A randomized controlled trial was conducted in 40 patients with a 6-week or longer history of neuropathic diabetic foot ulcer. The patients were randomized to two groups: group 1 (n = 20) received treatment with the protease-modulating dressing while the control group (group 2; n = 20) received the treatment specified in the standardized protocol for good wound care. The patients were then followed-up for 6 weeks.

Results: After 6 weeks, healing was achieved in 12 patients (63% of n = 19) in group 1 under treatment with the protease-modulating dressing versus three patients (15% of n = 19) in the control group (p < 0.03). The mean time to healing was 23.3 +/- 9.9 days in group 1 and 40.6 +/- 1.15 days in group 2 (p < 0.01).

Conclusions: The results confirm the hypothesis that the use of protease-modulating dressings in patients with neuropathic diabetic foot ulcers leads to better tissue regeneration than good wound care.