Amicapsil and Virtual Care to treat Diabetes Foot Ulcers
Research type
Research Study
Full title
Assessing the use of Amicapsil and a Virtual Care (Telemedicine) approach to treat Diabetic Foot Ulcers
IRAS ID
289944
Contact name
Brian Kennon
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
Duration of Study in the UK
0 years, 4 months, 5 days
Research summary
The treatment of wounds in the UK annually involves 278 million patient-healthcare professional face-to-face meetings to change patient wound dressings. The existing wound care products have limited efficacy which means wounds need continued care and cost the NHS £17.3 billion annually. They result in 20,000 tonnes plastics and chemical waste, over 1 million tonnes CO2-emission due to the involved transport and the release of hundreds of tonnes of antimicrobials into the environment, which reduce biodiversity and cause climate change.
The proposed feasibility study aims to 1) assess the use of Amicapsil, a novel already approved, efficient and easy to use treatment, in the management of diabetes foot ulcer and 2) assess a telemedicine approach to reduce the impact of wounds and their care on patients, the NHS and the environment.
Amicapsil is a Class II medical device approved in 2016 as a wound treatment in the EU including UK. In clinical in-hospital and community care studies, it has demonstrated improved efficacy. Amicapsil only contains natural ingredients, i.e. no plastics, toxic chemicals or antimicrobials. Furthermore, it is suitable for telemedicine because its ease of use allows the patient/family to perform the dressing changes; a wound evaluator will daily review photos of the wound and instruct how to proceed. The wounds are expected to heal within 2 months.
Funding is provided by Innovate-UK. The study will enrol 15 persons with diabetes with a foot ulcer less than 8 weeks old. This group is highly vulnerable to Covid-19 and will benefit strongly from the reduced number of face-to-face encounters. Furthermore, the majority of foot ulcers currently become non-healing and frequently require amputation and the unmet clinical need is high. Participants in community will be recruited by NHS-Greater-Glasgow-and-Clyde. If the findings are positive, this approach potentially extends to all wound types.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
20/EM/0273
Date of REC Opinion
11 Dec 2020
REC opinion
Further Information Favourable Opinion