That is all because these clinical trial guidelines have been produced and are being followed that we’re now seeing new, properly designed trials that are giving us hope that we have some evidence-based treatments that will help hard-to-heal ulcers, not all ulcers, those that don’t heal with standard of care to really respond to therapy with a good evidence base with more hope of healing. Hello. My name is Andrew Boulton, past President of EASD and currently professor of medicine at the University of Manchester, UK, and a visiting professor at the University of Miami, Florida, USA. Now, when I first started seeing patients with diabetic foot problems rather a long time ago, my first diabetic clinic was in 1978, but I remember going to meetings of the American Diabetes Association in the 1980s. And starting research as I was then in the diabetic foot, I would go and hear people talking, so I’ve done six cases with this therapy, it works, that’s the way to treat. But now in the 21st century, surely we should be in the era not of anecdote, but of good clinical practice with evidence-based medicine. So I think one of the most important papers, I’m not talking about an original article but a review, it was written by William Jeffcoate and and colleagues in the Lancet Diabetes Endocrinology in 2016, where he and colleagues from the International Working Group on the Diabetic Foot really outlined how a good randomised clinical trial should be done to show new therapies are efficacious in the management of foot ulcers in diabetes. One of the major problems, if you look at studies from the 1990s and 1980s, the very beginning of randomised controlled trials, but they did not take account of confounding variables, one of these being offloading. People will walk on a foot ulcer because they can’t feel it, and the companies designing trials forgot this. And we saw trials of topical platelet-derived growth factors, artificial skin, all sorts of trials that really didn’t take this into account. Therefore, the results were really unimpressive, even though there might be slight statistical benefits shown. This paper in 2016 outlined how a clinical trial should be designed with about 20 points that should be considered, and good papers should have a checkbox that all these points have being taken into consideration: proper blinding, proper randomisation, taking into account offloading and other confounding variables, which is so common in the foot. This is followed by another paper by Jeffcoate and colleagues published in Diabetes Care in 2018, and both these references will be available to you. In 2018, there was a nice review by Edmonds talking about a renaissance in diabetic foot care outlining that we’re beginning to see good clinical trials, that are changing our approach. In other words, evidence-based medicine has arrived in the diabetic foot and there are now a number of studies being published, for example, sucrose octasulfate dressing which may affect matrix metalloproteinases, the LeucoPatch or 3C Patch. Trials of topical oxygen are now showing that topical oxygen is highly efficacious in complex hard-to-heal diabetic foot ulcers. That all because these clinical trial guidelines have been produced and are being followed that we’re now seeing new, properly designed trials that are giving us hope that we have some evidence-based treatments that will help hard-to-heal ulcers, not all ulcers, those don’t heal with standard of care to really respond to therapy with a good evidence base with more hope of healing. And the key thing with a foot ulcer is to heal it. An open wound is a portal of entry for infection. And it’s a combination of infection and often ischaemia that leads to hospitalisation and, sadly still, amputation. So please read the guidelines. If you’re thinking of doing studies in the diabetic foot, and we need them, new treatments, that’s really the baseline of how to design, and how to proceed. So I wish you luck.