Urgo Medical

The Clinical Trial EXPLORER is the First Study to Demonstrate the Efficacy of a Dressing (Urgostart®) in Diabetic Foot Ulcer Healing

LOUGHBOROUGH, England, March 20, 2018 /PRNewswire/ --

A revolution in diabetic foot ulcer treatment and care 

Published in The Lancet Diabetes & Endocrinology, the EXPLORER ^[1] clinical trial is the first clinical study to demonstrate the efficacy of a dressing in the treatment of diabetic foot ulcers. UrgoStart® heals 60% more patients compared to a well-managed standard treatment, and reduces healing time by 60 days (compared to the average healing time of 180 days using a standard protocol) .

This represents a major therapeutic advance for diabetic foot ulcer patients as well as for health professionals dealing with the condition. 

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Diabetic foot ulcers are one of the major complications of diabetes. Between 19% and 34% of all diabetics will develop a foot ulcer at some point in their lives^[2]. This very high frequency is extremely concerning, especially bearing in mind that by 2040 some 640 million people throughout the world will suffer from diabetes^[3].  

With one amputation carried out every 20 seconds, diabetes is the world's leading cause of amputation^[4]. Within the diabetic population in England, 7,000 people are affected each year^[5]. Following amputation, life expectancy for these patients is below 5 years in around 70% of cases^[2].  This survival rate is well below that of some cancers^[6] .

These alarming figures reflect a genuine public health challenge, both for patients suffering from a potentially life-threatening condition, and for healthcare systems having to bear the costs. The estimated cost of this condition (diabetic foot ulcers requiring hospital admission and amputations) in 2014-15 was estimated at £1 billion per year^[5].

Until now, no dressing with proven efficacy in healing these wounds existed.

THE EXPLORER STUDY, HOPE FOR DIABETICS 

Conducted on 240 patients across five European countries, the Explorer study represents a clinical research first in the field of diabetic foot ulcers. The randomised, double-blind (neither patient nor doctor know which dressing is used to treat the wound) study compares the efficacy and tolerance of the UrgoStart^® (TLC-NOSF* matrix) dressing to those of a neutral dressing on neuro-ischaemic diabetic foot ulcers. These ulcers are the wounds with the poorest prognosis due to their simultaneously neuropathic and vascular component (they damage the peripheral nerves and arteries).