Game F, Jeffcoate W, Tarnow L, Jacobsen JL, Whitham DJ, Harrison EF, Ellender SJ, Fitzsimmons D, Löndahl M, LeucoPatch II trial team., et al.
The lancet. Diabetes & endocrinology. Date of publication 2018 Nov 1;volume 6(11):870-878.
1. Lancet Diabetes Endocrinol. 2018 Nov;6(11):870-878. doi:
10.1016/S2213-8587(18)30240-7. Epub 2018 Sep 19.
LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the
UK, Denmark, and Sweden: an observer-masked, randomised controlled trial.
Game F(1), Jeffcoate W(2), Tarnow L(3), Jacobsen JL(4), Whitham DJ(5), Harrison
EF(5), Ellender SJ(5), Fitzsimmons D(6), Löndahl M(7); LeucoPatch II trial team.
Collaborators: Dhatariya K, Chant H, Spyer G, Donohoe M, Uchegbu E, Whitelaw D,
Nayar R, Rossing P, Gottlieb H, Michelsen M, Nielsen AM, Houlind K, Sørensen J,
Henneberg E, Jørgensen B, Narayanan K, Kong MF, Tarik A, Gandhi R, Hariman C,
Oguntolu V, Rayman G, Siddique H, D'Costa R, Maguire D, Aung T, Holmer H, Catrina
SB, Ogunko A, Rajbhandari S, Russell D.
Author information:
(1)Department of Diabetes and Endocrinology, Derby Teaching Hospitals NHS
Foundation Trust, Derby, UK. Electronic address: frances.game@nhs.net.
(2)Department of Diabetes and Endocrinology, Nottingham University Hospitals
Trust, Nottingham, UK.
(3)Steno Diabetes Center Zealand, Holbaek Sygehus, Holbaek, Denmark; Department
of Clinical Research, Nordsjaellands Hospital, Hillerød, Denmark.
(4)Statcon ApS, Kokkedal, Denmark; Department of Biostatistics, University of
Copenhagen, Copenhagen, Denmark.
(5)Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham,
Nottingham, UK.
(6)Swansea Centre for Health Economics, Swansea University, Swansea, UK.
(7)Department of Endocrinology, Skane University Hospital, Lund, Sweden;
Department of Clinical Sciences, Lund, Lund University.
BACKGROUND: The LeucoPatch device uses bedside centrifugation without additional
reagents to generate a disc comprising autologous leucocytes, platelets, and
fibrin, which is applied to the surface of the wound. We aimed to test the
effectiveness of LeucoPatch on the healing of hard-to-heal foot ulcers in people
with diabetes.
METHODS: This was a multicentre, international, observer-masked, randomised
controlled trial of people with diabetes and a hard-to-heal foot ulcer done in 32
specialist diabetic foot clinics in three countries (UK, Denmark, and Sweden).
After a 4-week run-in period, those with a reduction in ulcer area of less than
50% were randomly allocated (1:1) by computer-generated, web-based randomisation
(block sizes of two, four, and six) to either prespecified good standard care
alone or care plus weekly application of LeucoPatch. The primary outcome was the
proportion of ulcers that healed within 20 weeks assessed in the
intention-to-treat population (all participants with post-randomisation data
collected), defined as complete epithelialisation (confirmed by an observer who
was masked to randomisation group), and remained healed for 4 weeks. This trial
is registered with the ISRCTN registry, number 27665670, and ClinicalTrials.gov,
number NCT02224742.
FINDINGS: Between Aug 30, 2013, and May 3, 2017, 269 participants were randomly
allocated to receive treatment (137 to receive standard care and 132 to receive
LeucoPatch). The mean age was 61·9 years (SD 11·6), 217 (82%) were men, and 222
(83%) had type 2 diabetes. In the LeucoPatch group, 45 (34%) of 132 ulcers healed
within 20 weeks versus 29 (22%) of 134 ulcers in the standard care group (odds
ratio 1·58, 96% CI 1·04-2·40; p=0·0235) by intention-to-treat analysis. Time to
healing was shorter in the LeucoPatch group (p=0·0246) than in the standard care
group. No difference in adverse events was seen between the groups. The most
common serious adverse event (SAE) was diabetic foot infection (24 events in the
LeucoPatch group [24% of all SAEs] and 20 in the standard care group [27% of all
SAEs]. There were no device-related adverse events.
INTERPRETATION: The use of LeucoPatch is associated with significant enhancement
of healing of hard-to-heal foot ulcers in people with diabetes.
FUNDING: Reapplix ApS.
Copyright © 2018 Elsevier Ltd. All rights reserved.
DOI: 10.1016/S2213-8587(18)30240-7
PMID: 30243803
