NNUH recruits patient to international trial
The Norfolk and Norwich University hospital has recruited its first patient into an international clinical trial.
The trial, which is investigating the safety of a new treatment for diabetes-related foot ulcers, will engage patients and hospitals from across the UK and worldwide.
Diabetic foot ulcers are sores on the feet which occur as a result of complications of diabetes, including nerve and blood vessel damage. Around 6.5% of patients who have diabetes will develop a foot ulcer over the course of their lifetime, and the most common diabetes-specific cause of an acute hospital admission is because of the ‘diabetic foot’, with most being due to ulceration and infection.
Charlie Francis, from Halesworth, has been selected to take part in the trial, having been treated by the diabetes service at the Norfolk and Norwich University Hospital for the past three years.
The Diabetic Foot Team is based within the Elsie Bertram Diabetes Centre at the hospital and provides specialist multidisciplinary foot clinics for patients with acute diabetic foot complications. This team is comprised of podiatrists, specialist nurses and has input from consultants in a range of specialties including diabetes, orthopaedics and vascular surgery.
Following the development of foot ulcers as a result of his diabetes, Mr Francis, who is 66, has already had one toe amputated.
Mr Francis said: “I was intrigued to be asked to take part in the trial. I have already had one toe removed, so was interested to understand the trials process, how new treatments are brought to patients and potentially prevent further amputations for myself in the future.”
Participation in the trial will involve being given three injections in the wound at three-weekly intervals. The participants will be in the study for a total of 24 weeks. At all other times, Mr Francis will be required to wear bespoke footwear in the form of a boot stretching from knee to foot, in order to reduce pressure on his affected foot.
Mr Francis is currently in the screening period and following the process of randomisation and confirmation that he fulfils the patient participation criteria, will be accepted into the international trial proper. Pending these steps, it is expected that Mr Francis will begin receiving injections from March 2017. As this is a randomised, ‘double blind’ trial, neither Mr Francis or the team from NNUH will know if Mr Francis is receiving the trial product or a placebo, in order to ensure that unbiased and effective monitoring can take place.
Mr Francis added: “I really like the fact that by participating in the trial I could be helping others, both patients and staff at the hospital. My family have all been very supportive and I’ve built such good relationships with the team here at NNUH that I’m looking forward to sharing this journey with them.”
Dr Ketan Dhatariya, NNUH Consultant in Diabetes and Endocrinology said: “At NNUH, and within the Diabetic Foot team in particular, we have a fantastic research set-up and are regularly involved in clinical trials of international importance. This particular trial seeks to improve healing rates and find a more effective treatment for a condition which is affecting a growing proportion of our population. The prevalence of diabetes continues to increase in the UK and we are excited to be a part of establishing new and innovative treatments to enhance care for our patients.”
Mr Francis will be joined by fellow patients in the trial and NNUH foot team are in discussions with two additional patients to establish whether they could also benefit from participation in the trial.
Professor Alastair Forbes, NNUH Chief of Research and Innovation said: “NNUH places research and innovation central to its culture, consistently seeking to advance treatment routes and techniques for the benefit of patients. Participation in the Phase 1B trial is a fantastic example of this commitment; I would like to thank Mr Francis for his involvement and wish him the very best on his treatment journey.”