Leucopatch II
Research type
Research Study
Full title
Leucopatch in the management of hard to heal diabetic foot ulcers
IRAS ID
118750
Contact name
Frances Game
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Research summary
Diabetic foot ulcers are the source of considerable suffering and cost and there are currently no wound care products available that have been demonstrated to improve healing, or that are cost effective. There have however been a small number of studies which have examined the use of platelets or fluid derived from platelets, either from the patients own blood or from blood bank products. These have suggested some promise, but have suffered from technical difficulties in making a suitable wound care product or the volume of blood required to derive the product. It is thought that the reason why they may work is that growth factors released by the platelets may stimulate the wound to heal. \nThis study will be a formal, randomised controlled trial to assess a new device for creating a wound care product which is a plug or patch conprising fibrin, white cells and platelets derived from 18 mls of the patients own blood. The application of this fibrin/white cell/platelet patch to the patients wound on a weekly basis will be compared with usual best care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25 centres in the UK, Denmark and Sweden..
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
13/WM/0202
Date of REC Opinion
24 May 2013
REC opinion
Favourable Opinion