Clinical trial NCT03883230: Wound Infection Detection Evaluation, WIDE
Official title: A Multi-centre, Controlled, Prospective Cohort Study Investigating the Accuracy of the Glycologic Limited Test Kit to Detect Bacterial Infection in Chronic and Delayed-healing Wounds.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Infection Bacterial
Ulcer Foot
Diabetic Foot
Diagnostic Self Evaluation
Lead sponsor: Cumbria Partnership NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic non-infected Diabetic Foot Ulcers (DFU) or other chronic and delayed-healing wounds will be recruited into the study. Patients will be recruited from the adult population seen routinely by the evaluation clinical staff.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* - Adult patients aged \> 18 years
* Patients with recurrent wounds, including multiple wounds, are eligible (including patients who have concluded participation in this study for one wound, but have another wound in another location).
* If infection occurs, and/or antibiotics applied, whilst in study then this is not deemed an exclusion criterion.
* DFU element: Clinical diagnosis of Diabetic Foot Ulcer (DFU) with wound duration \> 30 days.
* Other Other chronic and delayed-healing wounds element: Clinical diagnosis of a chronic or delayed-healing wound, with the wound present for at least 6 weeks. To include:

  * Pressure ulcer
  * Leg ulcer (can be venous, mixed or arterial in nature)
  * Non-diabetic foot ulcer
  * Post-operative wound
  * Trauma or other non-surgical wounds

Exclusion Criteria:

* - Aged \< 18 years
* Any reasons for the patient being unable to follow the protocol, including lack of mental capacity to consent to taking part in the study.
* The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives
* DFU element only:
* Confirmed and ongoing wound infection at baseline which is already being treated with systemic antibiotics.

Primary outcomes:
measure: GLYWD test result
timeFrame: 10 minutes
Secondary outcomes:
measure: Microbiology result of wound swab
timeFrame: 2 days
measure: Clinician's wound characterization
timeFrame: 1 minute
Other outcomes:
Locations:
city: Carlisle
country: United Kingdom
facility: Research & Development Department
state: Cumbria
Study officials:
affiliation: Cumbria Partnership NHS Trust, UK
name: Leon Jonker, PhD
role: PRINCIPAL_INVESTIGATOR
References: