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).  

The results: 

• A significantly higher healing rate compared to a well-managed standard treatment, representing +60% more patients healed.

• A significantly shorter healing time (reduced by 60 days) compared with the average healing time in the control group of 180 days.

• When the UrgoStart treatment is initiated early, it significantly increases the chances of the patient being healed compared to a well-managed standard treatment.

"Each day that a patient with diabetes has a foot ulcer, there is the risk of infection and amputation. The Explorer study showed that UrgoStart healed more neuro-ischaemic foot ulcers than standard treatment and on average 60 days more quickly.  This reduces the risk of infection and saves money," enthuses Dr. Michael Edmonds, Professor of Diabetic Foot Medicine at King's College Hospital (London).

"The Lancet Diabetes & Endocrinology is one of the most respected international scientific journals. Publication of the EXPLORER study in such a prestigious journal underlines the quality of the study and the significance of its results", specifies Gavin Ashton, Urgo UK Managing Director. "More than a dressing, it is a genuine treatment that has a full role to play in the protocol for chronic foot ulcers in diabetic patients."

Find out more about Urgo Medical: 

Please visit http://www.urgo.co.uk

UrgoStart®: Indications: the treatment of chronic wounds (leg ulcers, pressure ulcers, diabetic foot wounds and acute wounds that have become chronic). Please read the leaflet carefully.

Class IIb medical device (GMed)

Manufacturer: Laboratoires URGO.

*TLC matrix impregnated with NOSF (Nano OligoSaccharide Factor) = KSOS (potassium sucrose octasulfate) 

References:

1. Edmonds M, Lázaro JL, Piaggesi A, et al. Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial. The Lancet Diabetes & Endocrinology. 20 December 2017. Online. (20^th March 2018 in print)
2. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med 2017; 376: 2367-75
3. International Diabetes Federation. IDF Diabetes Atlas 7th edition; 2015.http://www.diabetesatlas.org (accessed 9 June, 2016).
4. Whiting, D. R., Guariguata, L., Weil, C., and Shaw, J. 2011. "IDF Diabetes Atlas: Global Estimates of the Prevalence of Diabetes for 2011 and 2030." Diabetes Res. Clin. Pract. 94 (3): 311-21.
5. National Diabetes Foot Care Audit Report 2014-2016 - NHS Digital, https://digital.nhs.uk/catalogue/PUB23525 (accessed 19 February 2018)
6. Walsh JW, Hoffstad OJ, Sullivan MO, Margolis DJ. Association of diabetic foot ulcer and death in a population-based cohort from the United Kingdom. Diabet Med 2016; 33: 1493-8.

Press contact:
Urgo Medical UK
Gavin Ashton
+44-150-950-1028
[email protected]