Randomized trial supports sucrose octasulfate for diabetic foot ulcers
medwireNews: Findings from the Explorer trial show that a sucrose octasulfate dressing improves wound closure of neuroischemic diabetic foot ulcers relative to a standard dressing.
Michael Edmonds (King's College Hospital, London, UK) and co-investigators say theirs is the first randomized controlled trial to compare two dressings in patients with diabetic foot ulcers.
The results show that 48% of the 126 patients randomly assigned to receive the sucrose octasulfate dressing achieved the primary outcome of wound closure over a median 115 days of treatment. By comparison, 30% of the 114 patients assigned to receive a dressing without sucrose octasulfate achieved wound closure over a median of 135 days.
The findings are published in The Lancet Diabetes & Endocrinology. In a linked commentary, Fran Game (Derby Teaching Hospitals NHS Foundation Trust, UK) describes the 18% difference in wound closure as “an impressive absolute improvement.”
The adjusted relative improvement with sucrose octasulfate was 2.6-fold, and the only other variable to significantly affect the primary outcome was wound duration, with longer-standing wounds slower to heal.
The patients were identified in 43 clinics in France, Spain, Italy, Germany, and the UK and were aged 64 years, on average. They had non-infected neuroischemic diabetic foot ulcers that were superficial in most patients, but penetrated to tendon or capsule in 24% of the sucrose octasulfate group and 13% of the control dressing group. Average wound duration was 7.3 and 7.1 months, respectively.
The average wound area was 5.3 and 4.2 cm2 in the sucrose octasulfate and control dressing groups, respectively, and the sucrose octasulfate dressing resulted in larger reductions in the median (although not mean) wound area.
In her commentary, Game stresses that the trial had independent randomization, blinding to treatment allocation for measurement of wound size, and standardization of offloading devices, which she describes as “gratifying” against a background of poor-quality research.
And she notes that the sucrose octasulfate dressing presents no extra challenges to use, “and therefore, apart from the dressing itself, there should be no additional costs in a treated patient’s clinical pathway.”
However, Game cautions that the generalizability of the findings remains to be confirmed, since the definition of neuroischemic is “not altogether clear” and the small number of patients included per center suggests that they might not have truly represented the overall patient population.
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