BIOME study
Research type
Research Study
Full title
Prospective, single-centre, cohort study assessing the potential application of WOUNDCHEK™ diagnostics for ulcer management
IRAS ID
314595
Contact name
Grace Messenger
Contact email
Sponsor organisation
North Cumbria Integrated Care NHS Foundation Trust
ISRCTN Number
ISRCTN11300898
Clinicaltrials.gov Identifier
BIOME study, BIOME study
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Chronic ulcer wounds of the legs and feet can be challenging for healthcare staff to manage. Patients often have co-morbidities and there is a considerable likelihood of non-healing and recurrence of ulcers, plus infection can occur. Apart from having a significant negative impact on patients’ lives, it is also a huge economic burden to the National Health Service. Clinical opinion – by checking for hallmark signs of infection - is the main way to determine if a wound is infected. Microbiology testing offers information on what type of antibiotic may help to treat the infection. Different companies have developed point-of-care tests that assess something that cannot be readily observed: bacterial protease activity. Its presence may be indicative of infection since bacteria use said protease enzymes to break down protein structures in a wound that are needed for a wound to heal. Due to logistic and cost reasons it would not be practical to apply a protease point-of-care test for all patients’ wounds. This study investigates to what degree clinical opinion and results of the WOUNDCHEK Bacterial Status test align, and also what factors and variables may be associated with non-matching results. Furthermore, the degree of influence the WOUNCHEK test result may have on clinical management of chronic lower limb ulcers will be explored. For this purpose a total of 258 wounds (minimum of 129 patients) will be assessed at baseline and then six and twelve weeks later.
Summary of Results
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0044
Date of REC Opinion
1 Feb 2023
REC opinion
Further Information Favourable Opinion