Background
Diabetic foot ulcers are a major cause of morbidity, mortality and health care expenditure. Silver dressings are frequently used for their reported antimicrobial properties however; no randomized control trials have been conducted to show benefit in patients with diabetic foot ulcers.
Methods
Consecutive patients were invited to participate if they had diabetes, an ulcer distal to the ankle and ulcer duration <6 weeks. Exclusion criteria included age <18y, allergy to silver, wounds with tendon exposed or osteomyelitis. Patients were randomized 1:1 to receive Acticoat dressing (Silver Group) or dressing without silver (Control Group). Stratified randomisation was performed to ensure presence of peripheral arterial disease and infection so that equal numbers were managed in the two groups. Patients received the designated dressing regime for 12 weeks or until healed, whichever occurred first. Secondary outcomes included rate of healing, infection and duration of antibiotics. The study will be completed when 200 wounds are recruited.
Results
To date, 84 wounds (46 Silver vs. 38 Controls) have completed the 12 week follow up period. There were no differences between the groups in age, sex and diabetes duration. There were no differences in the number of wounds healed at 12 weeks (70% Silver vs. 68% Controls, p=0.91), in mean time to healing (5.3 weeks Silver vs. 4.0 Control, p=0.06) or in length of antibiotic use (25 days silver vs. 35 control, p=0.54). The time to achieve 50% reduction in wound size was lower in the Control vs. Silver group (2.6 weeks vs. 3.6, respectively, p=0.025).
Conclusion
In this preliminary analysis, silver dressings did not achieve greater healing rates or reduced days of antibiotic use, in patients with acute diabetic foot ulcers. There is a trend to earlier healing and time to 50% reduction in the control group in this preliminary data.