A major international randomized controlled trial (RCT) has just been published in the internationally recognized journal The Lancet Diabetes & Endocrinology and documents the effect of a new treatment, LeucoPatch®, which offers significant enhancement of healing of hard-to-heal foot ulcers.
- The Danish medtech company Reapplix has paved the way for commercialization of its new technology, LeucoPatch®, which may save patients with hard-to-heal foot ulcers from amputations and the related risk of premature death
- A newly published RCT shows that LeucoPatch® has a significantly better effect on chronic diabetic foot ulcers than standard care. The study, which was the first of its kind, was published this week in The Lancet Diabetes & Endocrinology
- In Denmark alone, 22,000 people suffer from diabetic foot ulcers, resulting in approximately 1,000 amputations each year, and a total estimated health economic cost of 5 billion DKK
- The marketing of LeucoPatch® technology has begun in Denmark. Reapplix holds the patents and the global rights to LeucoPatch®
Reapplix is now primed to market its novel product LeucoPatch®. This provides new hope to people globally who suffer from very hard to heal diabetic foot ulcers. Paving the way for this milestone are the results of an international five-year research project showing that LeucoPatch® has a significantly better effect on chronic diabetic foot ulcers than traditional treatment.
The results have just been published in the internationally recognized journal The Lancet Diabetes & Endocrinology and are to be presented at the Diabetic Foot Study Group Conference 28-30 September 2018, and at the annual meeting of the European Association for the Study of Diabetes (EASD), 1-5 October 2018, both in Berlin.
Fewer amputations and better socioeconomics
The significant results of this study on LeucoPatch® mean that a large group of people could potentially avoid the serious consequences that diabetic foot ulcers may cause. In Denmark alone, more than 22,000 people (according to the Danish Health Board’s numbers from 2013) suffer from foot ulcers as a result of diabetes. Hard to heal foot ulcers result in amputation in 15-25 % of cases, which means that in Denmark alone every year, approximately 1,000 diabetics have their toes, feet or legs amputated.
According to figures from KORA (Det Nationale Institut for Kommuners og Regioners Analyse og Forskning), treatment of diabetic foot ulcers entails health economic costs a year of about DKK 5 billion in Denmark alone (2012), and results in productivity loss and possibly premature death. With such an expense associated with diabetic foot ulcers and an increasing proportion of people with type 2 diabetes, even a minor improvement in treatment options could offer significant health and socioeconomic gains.
“People with diabetes and chronic foot ulcers are a patient group for which there has not been adequate treatment. Therefore, there is no doubt that the product has a great potential in future wound treatment. And that means that it makes sense in economic terms as well for municipalities, regions and, in particular, patients” says Lise Tarnow, who has been the leading investigator of the Danish part of the research project and is currently the center director at Steno Diabetes Center Zealand.
From research to finished product:
Behind the development of LeucoPatch® is the Danish medtech company Reapplix. LeucoPatch® is a patch, manufactured using only the patient’s own blood and placed directly on the foot ulcer. It is based on a novel idea of utilizing the wound healing effects found in blood components – including leucocytes, fibrin and platelets – that people with long term diabetes, due to many years of disease, lack the ability to exploit due to impaired blood flow to their feet.
“It is very satisfying to see our idea become a finished product that works really well. Now we are looking forward to making it widely available to hospitals and wound clinics for the many people suffering from severe foot ulcers” says Niels Erik Holm, COO at Reapplix and the inventor of LeucoPatch®.
The marketing of LeucoPatch® has begun in Denmark, where several hospitals and wound centers are already applying the technology, including Bispebjerg Hospital. Reapplix holds the patents and the global rights to LeucoPatch®.
Facts about the research results:
UK, Danish and Swedish researchers have, in a randomized controlled trial with 269 patients at 32 hospitals and wound centers, compared the effect of LeucoPatch® with traditional wound treatment under the heading ‘LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomized controlled trial’. The study is now completed and shows that LeucoPatch® results in improved wound healing over 20 weeks (Odds Ratio of 1.58; p-value=0.0235). During the period 34 % of the LeucoPatch® group patients healed against only 22 % in the control group. Time to healing was 72 days for LeucoPatch® against 84 days in the control group. In the study, there were no side effects in treatment with LeucoPatch®.
The international journal The Lancet Diabetes & Endocrinology has just published the study. The article states: “The use of LeucoPatch is associated with significant enhancement of healing in hard-to-heal foot ulcers in people with diabetes.”
Graeme Brookes, CEO
+45 53 77 74 47
Reapplix is a Danish medtech company, founded in 2008 by Niels Erik Holm and Rasmus Lundquist. Reapplix’s core technology is based on the development of blood-based treatments for patients. The company’s first patented product is LeucoPatch® for the treatment of diabetic foot ulcers. Reapplix is a privately-held company backed by three leading Danish investors, SEED Capital, Novo Seeds and Vækstfonden (The Danish Growth Fund), and has been supported by Markedsmodningsfonden.