UK health watchdog NICE recommends new lower limb ulcer treatment which could prevent 3,000 amputations a year...
A new treatment option for venous leg ulcers and diabetic foot ulcers that could prevent more than 3,000(1) diabetes-related amputations is recommended by NICE(2) (The National Institute for Health and Care Excellence), following a comprehensive review of ground-breaking clinical studies in addition to expert opinion and advice.
At any one time 115,000 people in the UK have a diabetic foot ulcer (DFU),(3,4) and each year 278,000 people are treated for venous leg ulcers (VLU).(5) Leg ulcers and diabetic foot ulcers take an average of 200 days to heal.(6)
Using UrgoStart instead of a non-interactive dressing closes 60% more wounds,7 which has a huge positive impact on the person's quality of life, NHS resources and the local health economy. If half of the people with a venous leg ulcer were treated with UrgoStart there would be an annual cost saving of £75 million to the NHS.(1,5) If half of the people with a diabetic foot ulcer were treated with UrgoStart, the NHS could save £19.6 million per year.(1,3)
Julie Mullings, Lead Nurse Tissue Viability, Manchester University NHS Foundation Trust, said:
"Patients really suffer both physically and psychologically when they develop an ulcer, significantly affecting their quality of life for many months and sometimes longer. If we can reduce the healing time by using the right dressings and treatments at the right time this will achieve the best outcome for the patient. NICE's decision to support this standardised evidence-based approach to reducing the time to heal is great news for nurses as well, as it frees up our time to spend with other patients in need."
Graham Bowen, Clinical Lead for Podiatry, Solent NHS Trust, said:
"This is tremendous news. Diabetes foot ulcers are extremely debilitating and can affect every aspect of the person's life. Urgo Medical's new treatment, which can significantly reduce the healing time of foot ulcers, will have a significant impact on thousands of patients living with this condition. As we know, over 90% of all diabetes related amputations are preceded by a single foot ulcer so speeding up the healing process could help prevent many unnecessary amputations. The NICE guidance shows that UrgoStart can have a major impact on clinical outcomes and reduces costs for the NHS which is good news for both patients and healthcare professionals."
NICE's decision means that thousands more people with venous leg ulcers and diabetic foot ulcers could benefit from this unique wound treatment.
One person who has already benefitted is 49 year-old company director, Tim Newman. He said:
"It's hard enough living with type 1 diabetes; a foot ulcer is an added stress. In the past, when I had a foot ulcer, treating it was such an arduous process. With UrgoStart it is so much easier and more effective - the skin soon started to look healthy around the ulcer and there was a better blood supply. The size reduced really quickly, going from a deep hole to nothing at all. I would recommend it to anyone." - (See the case study further down the page).
UrgoStart is a wound dressing that works in a unique way to stop enzymes in the body harming new healthy tissue. These enzymes, known as Matrix Metalloproteinases (MMPs), are initially needed to clear away damaged cells but when they are in excess they start to work against the body's healing process. UrgoStart's unique technology stops that in its tracks and also promotes the growth of new blood vessels to further heal the ulcer. (7,8)
Gavin Ashton, Managing Director of Urgo Medical said:
"We're absolutely delighted by this announcement. We have an intensive research and development programme which we believe is revolutionising the wound healing market. UrgoStart is more than a dressing; it is a treatment that has a full role to play in the protocol of patients with leg ulcers and diabetic foot ulcers."
"The NICE decision endorses our commitment to developing evidence-based treatments and means thousands more patients will have access to the UrgoStart treatment range."
"We aim to meet the needs of the medical profession by helping to improve the quality of care they can provide to patients, and we are simultaneously saving the NHS money."
UrgoStart (Urgo Medical) is an interactive dressing for treating diabetic foot ulcers, leg ulcers and pressure ulcers.
UrgoStart is composed of a unique TLC-NOSF Healing Matrix (NOSF impregnated in a TLC healing matrix), which reduces healing time.
UrgoStart Plus is part of the same treatment range, composed of two exclusive technologies;
UrgoStart Plus, in addition to reducing healing time, offers simplification of treatment choice: one single solution for all leg ulcers, diabetic foot ulcers, pressure ulcers acting from day 1 to complete healing.
There are 5 formats of the dressing and each comes in different sizes:
UrgoStart is a lipido-colloid dressing (hydrocellular type) with soft-adherent TLC-NOSF Healing Matrix (NOSF* impregnated in a TLC healing matrix). CE marked as a class IIb medical device.
* NOSF (Nano OligoSaccharide Factor) = KSOS (potassium sucrose octasulfate)
Tim Newman - UrgoStart
Tim, from Essex, was diagnosed with Type 1 Diabetes on his 14th birthday. In the last ten years the 49 year old, a Company Director and Business Development Manager, has noticed lots of additional complications, such as poor eyesight, nerve damage (neuropathy) -- and diabetic foot ulcers. He has had lots of different types of treatment, but none have had as positive an impact as UrgoStart.
His first DFU developed in 2011. Since then he has had five DFUs, with little space between the initial onset and subsequent recovery of each. These have been caused by wearing poor fitting 'off the shelf' shoes compared to the physical shape of the foot, blisters from new shoes and the most recent, from scuffing the underside of his left foot on a volcanic rock in the sea in Lanzarote. In 2012, after his uncle was diagnosed with lymphoma, Tim signed up to do a 10k run to raise money for Cancer Research, despite having a DFU, and raised over £3000. But whilst training, he further damaged the two outside toes on his right foot, which brought about osteomyelitis, an infection which attacks the bone from the inside out, systematically destroying the bone structure. Two years later, due to the damage caused, his fourth toe had to be amputated.
Having a DFU affects everything. You can't shower without wearing a waterproof boot on your foot. You often have to wear an air-boot to offload pressure on the affected area. Finding well structured and perfectly fitting 'off the shelf' footwear is generally impossible. 'The worst thing is that they smell; they are disgusting things,' says Tim. 'Because you are unable to clean your feet like you would normally, they really start to stink. You're conscious that other people can smell it.'
His most recent and largest DFU (35mm diameter probing) which led to life threatening sepsis and pneumonia in October 2017 was, once the infection had cleared, treated with UrgoStart. 'They told me about a new treatment that was in development stages.' The recovery was rapid, and changes happened quickly. 'The infection disappeared completely, the appearance changed, the skin started to look healthy around the wound, and there was a better blood supply. The size reduced really quickly, first at 1mm a week, then 2mm a week, going from a deep hole to nothing at all.'
It's made a massive difference to his quality of life. During the treatment there were no extra dressings needed, and he could wear normal shoes, keeping the pressure off his foot. The dressings didn't need changing as frequently, yet the results were more noticeable. He could get back to work and move around. Keeping fit and healthy is important to Tim, and he can now be active, and get back to walking his Husky, Sika.
As well as having a positive personal impact, Tim says that 'the reduction in and, ultimately, the obvious time and cost saving on the NHS resources in attending regular hospital and community podiatry appointments seems to be a no-brainer where the rapid recovery provided by UrgoStart as a treatment is concerned.' It's made a difference to his life, and could do to many others.
Urgo Medical is a global wound care company offering a range of innovative dressings, compression bandages and hosiery, all designed to improve wound healing and patient quality of life.
Urgo Medical believe strongly in evidence-based care and pride themselves on their products having the highest level of clinical evidence available. Their focus is working in partnership with healthcare professionals to help move from managing wounds to healing wounds. They offer market-leading education and support through an experienced clinical team to help to improve patient outcomes and reduce healing time.
Urgo Medical's innovative treatments and services are tailored to patients and healthcare professional needs, providing life changing solutions for wound healing.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in health and social care. It develops national guidance, standards and information on high-quality health and social care to improve outcomes for clinicians and patients.
NICE Medical Technology Guidance aims to help the NHS adopt clinically effective and cost effective technologies quickly.
It is developed by independent committees who review all of the best evidence and expert opinions to turn it into actionable recommendations. The guidance development process includes the review of:
For further details: www.urgostartplus.co.uk
(1) Data on file.
(2) NICE Guidance Medical technology guidance: UrgoStart for treating diabetic foot ulcers and leg ulcers. Available at: https://www.nice.org.uk/guidance/mtg42.
(3) Kerr M. Diabetic Footcare in England: an economic study, January 2017. Insight Health Economics for Diabetes UK.
(4) Diabetes UK prevalence figures. Available at: https://www.diabetes.org.uk/professionals/position-statements-reports/statistics. Last accessed: January 2019.
(5) Guest JF, Ayoub N, McIlwraith T et al. Health economic burden that different wound types impose on the UKs National Health Service. International Wound Journal. 2017. 6: 186-96.
(6) French Health Insurance Report to the Ministry of Health for 2014, July 2013.
(7) Edmonds M, Lázaro-Martínez JL, Alfayate-García JM, Martini J, Petit JM, Rayman G,Lobmann R, Uccioli L, Sauvadet A, Bohbot S, Kerihuel JC, Piaggesi A. Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial. Lancet Diabetes Endocrinol. 2018 Mar;6(3):186-196 Available at: https://www.ncbi.nlm.nih.gov/pubmed/29275068.
(8) White, R., Cowan, T., Glover, D. Supporting evidence-based practice: a clinical review of TLC healing matrix (2nd edition). MA Healthcare Ltd, London, 2015.
(9) Meaume S, Dompmartin A, Lazareth I, Sigal M, Truchetet F, Sauvadet A, Bohbot S. Quality of life in patients with leg ulcers: results from CHALLENGE, a double-blind randomized controlled trial. Journal of Wound Care. 2017; 26 (7): 368-379.
(10) Meaume S, Truchetet F, Cambazard F, et al. A randomized, controlled, double-blind prospective trial with a Lipido-Colloid Technology-Nano-OligoSaccharide Factor wound dressing in the local management of venous leg ulcers. Wound Repair Regen 2012; 20: 4, 500--511.
(11) Münter KC, Meaume S, Augustin M, Senet P, Kérihuel J.C. The reality of routine practice: a pooled data analysis on chronic wounds treated with TLC-NOSF wound dressings. J Wound Care. 2017 Feb; 26 (Sup2): S4-S15. Erratum in: J Wound Care. 2017 Mar 2; 26(3): 153.
(12) An Economic Evaluation of UrgoStart® for Patients with Chronic Leg Ulcers in the United Kingdom. York University. Data on file. Urgo, 2011.
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