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Trial results promising for new wound care treatment

Trial results promising for new wound care treatment

A recent report, published in The Lancet Diabetes & Endocrinology, carries results which suggest a significant therapeutic advance for diabetic foot ulcer patients, as well as for health professionals dealing with the condition.

The EXPLORER  clinical trial is the first clinical study to indicate the efficacy of a dressing in the treatment of diabetic foot ulcers.

The randomised, double-blind trial involved teams in 43 hospitals with specialised diabetic foot clinics in France, Spain, Italy, Germany and the UK. One was a team from Salford Royal Hospital led by College of Podiatry Clinical Director, Professor Paul Chadwick.  

The aim was to assess the effect of a sucrose octasulfate dressing versus a control dressing on wound closure in patients with neuroischaemic diabetic foot ulcers.

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 type of dressing.

Over a period of three years, 240 individuals took part in the trial. Of these, 126 were treated with the sucrose octasulfate dressing under investigation and 114 with a control dressing of the type usually used to dress this type of wound.

After 20 weeks, 18% more wound closures were recorded in the sucrose octasulfate dressing group, compared to the control dressing group and there was there was an observed 30% improvement in healing. The expected time to wound closure for all participants – as determined by Kaplan-Meier analysis – was 180 days in the control group and only 120 days in the sucrose octasulfate dressing group.

The results suggest a significant improvement in wound-healing resulting from treatment with the sucrose octasulfate dressing. Until now, no dressing with proven efficacy in healing these wounds existed, so this is potentially a ground-breaking development in wound care.

Complications from diabetic foot disease cost the NHS in England more than a billion pounds a year, and every day 23 people with diabetes in England have a toe, foot or leg amputated. These amputations are often preceded by diabetes-related foot ulcers, and the 5-year survival rate after a diabetic foot ulcer is only 58%, similar to that for colorectal cancer and lower than for breast or prostate cancer. Improved wound care could pave the way for improved survival rates.

College of Podiatry Clinical Director, Paul Chadwick who was Principal Investigator in the Salford Royal Hospital team said:

“The results of this trial are encouraging. With these kinds of wounds increasing as the prevalence of diabetes continues to increase, we really need research into better management and treatments. While addressing the increase in the underlying condition, we can simultaneously address its consequences and take a multi-pronged approach to saving limbs and potentially lives.”