Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial

Publication date: Available online 20 December 2017 Source:The Lancet Diabetes & Endocrinology Author(s): Michael Edmonds, José Luis Lázaro-Martínez, Jesus Manuel Alfayate-García, Jacques Martini, Jean-Michel Petit, Gerry Rayman, Ralf Lobmann, Luigi Uccioli, Anne Sauvadet, Serge Bohbot, Jean-Charles Kerihuel, Alberto Piaggesi Background Diabetic foot ulcers are serious and challenging wounds associated with high risk of infection and lower-limb amputation. Ulcers are deemed neuroischaemic if peripheral neuropathy and peripheral artery disease are both present. No satisfactory treatment for neuroischaemic ulcers currently exists, and no evidence supports one particular dressing. We aimed to assess the effect of a sucrose octasulfate dressing versus a control dressing on wound closure in patients with neuroischaemic diabetic foot ulcers. Methods We did a randomised, double-blind clinical trial (Explorer) in 43 hospitals with specialised diabetic foot clinics in France, Spain, Italy, Germany, and the UK. Eligible participants were inpatients or outpatients aged 18 years or older with diabetes and a non-infected neuroischaemic diabetic foot ulcer greater than 1 cm2 and of grade IC or IIC (as defined by the University of Texas Diabetic Wound Classification system). We excluded patients with a severe illness that might lead to them discontinuing the trial and those who had surgical revascularisation in the month before study entry. We randomly assigned pa...
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research