Dressing that promotes healing moves closer to clinical trial
Date: March 30, 2020
A dressing that can speed up healing in chronic wounds is undergoing regulatory approval in preparation for its first trial with patients.
The wound dressing, developed with IKC support, is impregnated with collagen fibres and can absorb enzymes released as part of the body’s response to wound healing. These enzymes can aggravate chronic wounds and prolong the healing process. Tests in mice showed wounds treated with the collagen dressing healed completely after 20 days, while untreated wounds were only 40 per cent healed.
The technology has been developed by a team at the University of Leeds, led by Dr Giuseppe Tronci. The team have successfully manufactured the dressing in a clean room environment and are now in a position to provide samples for use in a clinical trial. A trial involving patients with ulcerated wounds on their fingers is planned to take place in Leeds. The trial has received ethical approval from the Health Research Authority, subject to approval of the dressing by the Medicines and Healthcare products Regulatory Authority (MHRA).
Advice and guidance
The IKC is currently helping the team through the MHRA medical device approval process, providing advice on how best to obtain the additional data required.
“The regulations have changed since we first began developing the dressing, so we’re having to go through a more stringent approval process than we initially envisaged,” Dr Tronci says. “It’s been really helpful having the IKC on board to steer us through that, helping to prepare the MHRA documents and addressing any queries that arise.”
Dr Tronci is also looking at adding further properties to the dressing by incorporating an anti-microbial function. Using funding from the IKC’s partner programme, Grow MedTech, he is working on incorporating a photosensitive dye – already in clinical use – into dressing-forming fibres. The dye is toxic to bacteria when activated by light and Dr Tronci plans to test whether it has the same action once it forms part of the dressing, while not harming human cells.
The aim is to reduce the need for antibiotics and help improve wound management, particularly for diabetic patients. People with diabetes can suffer from nerve damage and reduced circulation which makes them more prone to developing wounds that are slow to heal and more likely to turn into chronic ulcers. The NHS currently spends nearly £1 billion a year on diabetic wound management, and the number of people with diabetes in the UK is set to rise to over five million by 2025.Back to Case Studies