Frances Game1, William Jeffcoate2, Lise Tarnow3, Judith L Jacobsen4, Diane J Whitham5, Eleanor F Harrison5, Sharon J Ellender5, Deborah Fitzsimmons6, Magnus Löndahl7. 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.
Abstract
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.
RCT Entities:
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.
Authors: Pamela Chen; Keryln Carville; Terry Swanson; Peter A Lazzarini; James Charles; Jane Cheney; Jenny Prentice Journal: J Foot Ankle Res Date: 2022-05-25 Impact factor: 3.050
Authors: Sarah Brown; Jane Nixon; Myka Ransom; Rachael Gilberts; Nikki Dewhirst; Elizabeth McGinnis; Roberta Longo; Frances Game; Chris Bojke; Paul Chadwick; Akila Chandrasekar; Ian Chetter; Howard Collier; Catherine Fernandez; Shervanthi Homer-Vanniasinkam; Edward Jude; Richard Leigh; Richard Lomas; Peter Vowden; James Wason; Linda Sharples; David Russell Journal: BMJ Open Date: 2020-04-19 Impact factor: 2.692