RegeniTherix CS2
Research type
Research Study
Full title
Assessment of the Safety and Efficacy of the RegeniTherix™ Theranostic System in Diabetic Foot Ulcers
IRAS ID
177379
Contact name
David Russell
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
The ultimate aim of our research is to develop a new wound dressing and device that will enable doctors and nurses looking after patients with open, nonhealing diabetic foot wounds to know how well they are healing and if there are any issues that might cause them to heal slowly.
This sample can then be placed in a measuring device that will give medical staff a more accurate and rapid understanding of what is happening on the surface of the wound and as such allows them to take action if needed. For example, if early signs of infection are identified in the wound then the correct type and dose of antibiotics can be administered. By allowing medical staff to identify problems earlier on, we can improve the chances of a full recovery by ensuring that the correct treatments are being given in a timelier manner, which in turn speeds up the healing process and reduces your time being treated at the wound clinic.This trial is a safety study of RegeniTherix™, a new theranostic device which combines a bioresorbable scaffold with a biocompatible, thermo-reversible hydrogel which can be used for point of care wound biomarker assessment. Biomarkers (for example Interleukin-6, Tumour necrosis factor-α, human neutrophil lysozyme and matrix metalloproteinase-9) will be recovered from the hydrogel and measured by point of care diagnostic devices or other suitable assays.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0153
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion