Prospective randomised placebo-controlled trial assessing the efficacy of silver dressings to enhance healing of acute diabetes-related foot ulcers.

ABSTRACT

AIMS/HYPOTHESIS: Silver dressings are used for their antimicrobial properties but there is limited evidence of clinical benefit when managing diabetes-related foot ulcers (DFUs). We aimed to assess whether silver dressings in acute DFUs increased the proportion of ulcers healed compared with non-silver dressings. METHODS: In this open-labelled, randomised controlled trial, consecutive individuals who presented to a tertiary multidisciplinary diabetic foot service with a DFU without osteomyelitis or tendon on view of <6 weeks' duration were randomised 11 via a computer-generated randomisation process to receive Acticoat (Smith & Nephew, England) dressing (silver group) or dressing without silver (control group) in addition to standard care. Stratified randomisation was performed to ensure that the presence of peripheral arterial disease and infection were equally managed within the two groups. The primary outcome was the proportion of ulcers healed at 12 weeks. Secondary outcomes included time to heal and to 50% ulcer reduction, rates of osteomyelitis and amputation, and need for and duration of antibiotics. RESULTS: Seventy-six ulcers (55 participants) in the control group and 91 ulcers (63 participants) in the silver group were included. There was no difference in the proportion of ulcers healed by 12 weeks in the control vs silver group (75% vs 69%, p=0.49). After adjustment for presence of peripheral arterial disease, infection and initial ulcer size, silver dressing was not associated with odds of healing (OR 0.92; CI 0.26, 3.22; p=0.53). There was no difference in time to healing, progression to osteomyelitis, need for amputation, or duration of or need for antibiotic treatment. CONCLUSIONS/INTERPRETATION: In individuals with acute DFUs without osteomyelitis or tendon on view, Acticoat silver dressings did not improve wound healing or reduce need for antibiotics compared with non-silver dressings. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12614001234606 FUNDING: Australian Diabetes Society-unrestricted research award.