Continuing Development of two Point of Care Diagnostic Devices

• Research type

  Research Study

• Full title

  Collection of Wound Fluid for the Continuing Development of two Point of Care Diagnostic Devices - POC-IT for testing for Various Biomarkers in Wound Fluid and I-Stick for Testing for Protease Activity in Wound Fluid

• IRAS ID

  246767

• Contact name

  Keith Harding CBE

• Contact email

  susan.taylor@wwic.wales

• Sponsor organisation

  Microarray Ltd

• Clinicaltrials.gov Identifier

  n/a, no additional reference numbers

• Duration of Study in the UK

  1 years, 1 months, 1 days

• Research summary

  The monitoring of healing and management of wounds remains largely reliant on somewhat subjective clinical observations and the accepted consensus is that there is sufficient evidence for clinicians to integrate selected signs and symptoms of infection into general wound assessment. Diagnostic devices which may assist non-health care practitioners and non-specialists caring for wounds, for more efficient delivery of wound care and better outcomes for patients at point of care (POC) are needed. An ability to evaluate rapidly at POC factors affecting the wound would give clinicians an unambiguous picture of the wound status and most appropriate treatment plan. The lack of diagnostic tests providing this information constitutes an unfulfilled need.

  This is the third is a series of Wound Fluid sampling studies and consists of Feasibility and Optimisation Phases for the development of two POC diagnostic devices. During the Feasibility Phase biomarker analysis will be undertaken to determine the most informative for differentiating between infected and non-infected wounds (POC-IT) and healing and non-healing wounds (I-Stick). During the Optimisation Phase further analysis will be undertaken to refine the designs which give the greatest predictive values for infection status (POC-IT) and healing status (I-Stick) for use in the prototypes.

  An Interim Analysis will be conducted when a minimum of 20 wound fluid samples have been collected from at least 10 patients (with a maximum of 20 samples from any one patient) from the following wound types:
  • infected Leg Ulcers (LU)
  • non-infected LUs
  • infected Diabetic Foot Ulcers (DFU)
  • non-infected DFUs
  • healing LUs
  • not healing LUs
  • healing DFUs
  • not healing DFUs
  • infected wounds
  • not infected wounds
  • healing wounds
  • not healing wounds

  The Interim Analysis will determine the minimum final numbers of samples and patients that will be needed to complete the Feasibility and Optimisation Phases.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  18/LO/0988

• Date of REC Opinion

  25 May 2018

• REC opinion

  Favourable Opinion