Diabetic foot ulceration places a huge socioeconomic burden on health resources and it is the causal event that leads to the vast majority of diabetes-related, lower-extremity amputations. This is even more concerning when around 7,000 people with diabetes in the UK are affected by foot ulceration at any one time (Game, 2018). The mainstay treatment regimen for these lesions is ensuring good arterial inflow, infection control and offloading. The elephant in the room regarding foot ulcer management is which dressing product is most effective and appropriate. This has been a hot topic at many conferences and there are, as I am sure you are aware, literally hundreds of products available with little robust evidence to guide choice.
With this in mind, I want to bring your attention to a paper recently published by Edmonds et al in the Lancet, which reports the outcome of a large multicentred, randomised double-blind dressing trial in diabetic foot ulcers. This study is unique as it only included patients with neuroischaemic foot ulcers, which are the most difficult to heal. The study was conducted in 43 hospital-based specialist centres across Europe (UK, Spain, France, Italy and Germany). A total of 240 subjects were recruited after a 2-week screening run in period. Ulcers had to be Texas grade 1 or 2C and banded into wound areas of 1–5 cm² and 5–30 cm². Standard care was given to both the active and control arm. Offloading was standardised across all sites to both study groups. Subjects were randomised (1:1) via a computer-generated code to the study dressing containing sucrose octasulfate or an identical dressing without sucrose octasulfate. The study period was for 20 weeks with a primary outcome of patients healed within 20 weeks, additionally validated quality of life and depression questionnaires were completed. After 20 weeks, 48% (n=60/126) of the study dressing group had healed versus 30% (n=34/114) in the control group. Additionally, ulcers healed more quickly in the study dressing group with a median duration of treatment being 135 days [IQR 56–141] for the control group and 115 days [IQR 56–141] for the study dressing group.
I would recommend this paper to be read fully and consider its impact upon your local guidelines.
To read the article summaries, please download the PDF.
