About 15% of all people with diabetes get foot ulcers, and they are a source of considerable cost and suffering. Despite improved outcomes with modern treatments, foot ulcers are still the main reason for leg amputations in people with diabetes in most western countries. There are currently no specific treatments which have been clearlyshown to improve the outcome, although studies with growth factors, particularly platelet derived growth factors have shown promise.
LeucoPatch® is produced from patient’s own venous blood by centrifugation, but without addition of any reagents. The final product comprises a thin circular patch composed predominantly of fibrin together with living platelets and leucocytes. The number of LeucoPatch® patches is adjusted to fit the individual wound.
The Leucopatch II Trial will demonstrate whether the application of LeucoPatch® when used in addition to usual care in a multidisciplinary diabetes foot clinic setting, is superior to usual care alonewith regard to complete healing of hard-to-heal diabetic foot ulcers. The study will also provide information on reduction in pain, decrease in ulcer area, amputations, well-being, costs and other clinical outcomes
Approximately 600 patients will be recruited from centres in the UK, Sweden and Denmark.
Recruitment to date:
We have now recruited all the patients we need for the trial, with a total of 595 patients consented and 269 randomised. Thank you to all involved.
A successful UK Investigator Meeting was held in Birmingham on 2nd February 2017. Representatives from 15 UK sites attended.
The first International Investigator Meeting for the LeucoPatch II Trial was held on 7 and 8 September 2015 on the edge of the beautiful Peak District in the UK.
The team at Gateshead randomised the 100th participant into the LeucoPatch II Trial in February 2015.
The first UK Investigator Meeting was held in Birmingham on 18 September 2013.