269
Participants
Start Date
August 31, 2013
Primary Completion Date
October 31, 2017
Study Completion Date
May 31, 2018
LeucoPatch
LeucoPatch® is prepared by centrifuging one or more 18mL aliquots of the participant's venous blood in the LeucoPatch device and bench-top centrifuge. The centrifugation yields a tough layer of fibrin, with viable white cells and platelets, and this is applied directly to the wound surface using sterile forceps. The wound is then covered with an inert primary dressing, secondary protective dressing and the ulcerated area protected with appropriate off-loading. The patch is prepared and applied each week for up to 20 weeks or until the wound is judged healed.
Usual care
"Usual wound care provided in a multidisciplinary foot care clinic , in accordance with international guidelines.~Components of usual wound care include:~* Formal assessment of ulcer and surrounding skin~* Provision of any necessary off-loading~* Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae)~* Appropriate dressing products~* Appropriate antibiotic therapy~* Nutrition and self care~* Optimal glycaemic control~* Revascularisation if deemed clinically necessary~* Continued close observation"
Kolding Sygehus, Kolding
Steno Diabetes Center, Gentofte Municipality
Herlev Hospital, Herlev
Nordsjællands Hospital, Hillerød
Bispebjerg Hospital, København NV
Odense University Hospital, Odense
Viborg Sårcenter, Viborg
Centralsjukhuset Kristianstad, Kristianstad
Skåne University Hospital, Lund
Karolinska University Hospital, Solna
Royal Cornwall Hospitals NHS Trust, Truro
South Devon Healthcare NHS Foundation Trust, Torquay
The Ipswich Hospital NHS Trust, Ipswich
The Mid Yorkshire Hospitals NHS Trust, Pontefract
Barnsley Hospital NHS Foundation Trust, Barnsley
Bradford Teaching Hospitals NHS Foundation Trust, Bradford
Lancashire Teaching Hospitals NHS Foundation Trust, Chorley
Dartford and Gravesham NHS Trust, Dartford
Derby Hospitals NHS Foundation Trust, Derby
The Dudley Group NHS Foundation Trust, Dudley
Royal Devon & Exeter NHS Foundation Trust, Exeter
Gateshead Health NHS Foundation Trust, Gateshead
Harrogate and District NHS Foundation Trust, Harrogate
The Leeds Teaching Hospitals NHS Trust, Leeds
University Hospitals of Leicester NHSTrust, Leicester
United Lincolnshire Hospitals NHS Trust, Lincoln
Norwich and Norwich University Hospitals NHS Foundation Trust, Norwich
Nottingham University Hospitals NHS Trust, Nottingham
Royal Berkshire NHS Foundation Trust, Reading
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield
City Hospitals Sunderland NHS Foundation Trust, Sunderland
Royal Wolverhampton Hospitals NHS Trust, Wolverhampton
Nottingham University Hospitals NHS Trust
OTHER