Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03883230 |
Other study ID # |
CP1713 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 27, 2017 |
Est. completion date |
January 31, 2020 |
Study information
Verified date |
July 2022 |
Source |
Cumbria Partnership NHS Foundation Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Chronic wounds, such as diabetic foot ulcers, place a huge burden on healthcare systems and
can lead to complications with high morbidity, particularly if the wound if infected. In
parallel, there is pressure to reduce the use of antibiotics in order to minimise the risk of
antimicrobial resistance. The Glycologic wound detection kit (GLYWD) is a point-of-care test,
designed to provide guidance to clinical staff as to whether a chronic wound is infected or
not. In this prospective cohort study the premise of this mode-of-action is evaluated. GLYWD
will be applied in conjunction with clinical opinion and microbiological testing to determine
if there is concordance between the different diagnostic approaches, and if applicable how
they may differ in certain patients' wounds.
Description:
The occurrence of diabetic foot ulcer (DFU) is a common complication of diabetes with
enormous cost implications, totalling £650 million per year once associated morbidity is
taken into account (NHS Diabetes report). Bacterial infection of wounds carries the risk of
further degenerative complications including cellulitis, necrotising fasciitis, and sepsis
(Grothier, 2015). Specific wounds, such as diabetic foot ulcers may lead to amputation if
osteomyelitis develops. An additional undesirable effect of infection of wounds is that it
delays - or stops altogether - the wound healing process (Halbert et al, 1992).
Detection of DFU infection remains reliant on clinical judgement. For example, imaging
modalities such as MRI do not perform better than clinical appraisal in terms of sensitivity
and specificity when it comes to detecting osteomyelitis (Dinh et al, 2008). O'meara and
colleagues (2006) concluded from a systematic review on clinical examination, sample
acquisition and sample analysis in DFUs that there is a lack of evidence regarding what
samples should be taken and how they should be analysed. They did suggest that
semi-quantitative sample analysis - a category that the Glycologic detection kit (called
GLYWD) would fall under - may be a useful alternative to quantitative analysis. Quantitative
detection of infection is still undertaken by swabbing the wound and then culturing the
pathogens in a microbiology laboratory. Obtaining these results generally takes days; even
molecular profiling does not give an instant result. Microbiological counts and species
identification do not necessarily reflect infection as defined by other assessments, as
demonstrated by Gardner et al (2014).
Clinical guidelines stipulate that the only available laboratory-based diagnostic option,
microbiological testing, should only be used to identify the pathogen strain in clinically
confirmed infection. Therefore, clinical opinion is the mainstay of predicting and diagnosing
infection (NICE, 2008, 2015). The lack of a simple cost-effective and repeatable testing
method may have three consequences: 1) lack of uniformity in diagnosis, due to differences in
clinical judgement, which in turn may result in 2) over-diagnosis of infection with
inappropriate prescription of antibiotics or antimicrobial dressings, or 3) late presentation
of patients with systemic signs and spreading cellulitis or osteomyelitis requiring hospital
admission and treatment with intravenous antibiotics or emergency surgery.
The provision of a rapid, reliable, sensitive and relatively low cost infection detection
test kit for infection, which can be used at point-of-care, has the potential to provide the
NHS with significant cost savings as well as improving the outcomes for patients. Therefore,
in this study the Glycologic diagnostic wound infection detection test (GLYWD) is evaluated
against clinical opinion and microbiological diagnostics to determine if it is an effective
tool for the rapid detection of chronic wound infection.