The role of chloramines in treatment of diabetic foot ulcers: an exploratory multicentre randomised controlled trial

BACKGROUND: Chronic foot ulcers in diabetes are serious, costly and frequently difficult to heal. Recent guidelines conclude that new dressings and treatments generally fail to show superiority compared with standard of care. Several mechanisms are probably responsible for impaired healing of chronic foot ulcers, including inflammation and infection. Chloramines have presumed antiseptic and antibacterial properties, and have shown to be a useful treatment in odontology. METHODS: In an explorative open randomised controlled multi-centre study, we compared chloramine-based treatment with current standard of care for 12 weeks and follow-up for 24 weeks. Seventeen patients in each group, mean age about 70, duration of diabetes > 20 years and foot ulcers about 1.5 years, completed the 12 weeks study. RESULTS: After 5 weeks, the difference between the groups in relative reduction in ulcer area was statistically significant (p=0.016). Absolute change in ulcer area was first statistically significant within the chloraminetreated group after 2 weeks (p=0.026), after 8 weeks in the control group (p=0.0023), with significant difference between groups after 5 weeks (p=0.024). The approximate relative decrease per week was 19.4% (95%CI 12.2, 26.0; p<0.0001) in the chloramine-treated group and 11.7% (95%CI 6.4, 16.7; p<0.0001; between-group difference p=0.083). After 9 weeks 7 patients had healed in the chloraminetreated group, but only one in the control group (p=0.039). There were no statistically significant differences in wound healing at 12 or 24 weeks, and no marked differences in signs of infection, pain, quality of life (EQ-5D), or incidence of adverse events. CONCLUSIONS: Chloramine-based treatment seems to be efficacious, particularly in the early phase of the care of infected diabetic foot ulcers. It is safe and easy to use, and could prove to be a valuable addition in the treatment arsenal, providing non-surgical debridement. Future studies will evaluate its role in wound care.