Wound Assessment Using Spectral Imaging (WAUSI)
Research type
Research Study
Full title
Wound Assessment Using Spectral Imaging (WAUSI)
IRAS ID
320712
Contact name
Chris Manu
Contact email
Sponsor organisation
Spectral MD UK Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, days
Research summary
Diabetic foot ulcers (DFU) are one of the most serious and widespread complications of diabetes. DFU are open sores or wounds typically found on the plantar surface of the foot. All DFUs are treated with 30 days of standard wound care (SWC) therapy. However, the current treatment and management regimen for DFU is limited in that SWC results in low percentages of healed DFU after 12 months of management, and therefore, advanced wound care is often necessary.
In this study the DeepView SnapShot™ Imaging System is used to capture and annotate DFU images for clinical investigations. This study is an observational, prospective, cohort study and up to 72 adults at 4 investigational sites (2 in UK and 2 in Ireland) will be enrolled.
The DeepView® imaging technology is intended as the first diagnostic device to identify, on the initial patient evaluation in diabetic subjects, a DFU that will not respond to SWC therapy. While other devices are available to aid in the assessment of a DFU, none of these technologies are effective in discriminating healing from non-healing DFUs. The system is non-patient contacting and does not emit ionizing radiation. The study device is not currently marketed in the EU or UK.
REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0147
Date of REC Opinion
28 Nov 2022
REC opinion
Favourable Opinion