title: Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study.
abstract: OBJECTIVE
  Leucopatch is a leukocyte and platelet-rich fibrin patch that provides concentrated blood cells and signal substances to the surface of an ulcer. It is produced by centrifugation of the patient's own venous blood. The aim of this pilot multicentre cohort study was to evaluate effects of the leucocyte patch in patients with hard-to-heal diabetic foot ulcers (DFUs).
  
  
  METHODS
  Non-ischaemic Wagner grade 1 or 2 DFUs with a duration of more than 6 weeks and a maximal area of 10cm² were included. Patients with >40% ulcer area change during a two-week run-in period were excluded. The treatment was applied once a week for up to 19 treatments or until the foot ulcer was completely epithelialised. The primary endpoint was healing within 20 weeks.
  
  
  RESULTS
  Of the 60 patients who gave consent 16 were excluded during run-in period, 44 patients initiated study treatment and 39 were included in the per-protocol analysis. Complete epithelisation was achieved in 34% (per-protocol analysis 36%) at 12 weeks and 52% (59%) at 20 weeks. In patients with ulcer duration less than 6 months, 73% of ulcers healed within 20 weeks. Patients with healed ulcers had larger ulcer area reduction during the first two treatment weeks compared to non-healers. Adverse events were mild and rare.
  
  
  CONCLUSIONS
  The leucocyte patch is well-tolerated, easy to use and has potential in the armamentarium of the DFU treatment, provided this outcome is confirmed in an appropriately powered randomised clinical trial.
authors: Department of Endocrinology, Skåne University Hospital, Lund, Sweden.
authors: M
authors: M
authors: Löndahl
authors: L
authors: L
authors: Tarnow
authors: T
authors: T
authors: Karlsmark
authors: R
authors: R
authors: Lundquist
authors: A M
authors: AM
authors: Nielsen
authors: M
authors: M
authors: Michelsen
authors: A
authors: A
authors: Nilsson
authors: M
authors: M
authors: Zakrzewski
authors: B
authors: B
authors: Jörgensen
mesh_terms: D000368:Aged; D001792:Blood Platelets; D015331:Cohort Studies; D017719:Diabetic Foot / Q000628:therapy*; D005260:Female; D005337:Fibrin / Q000627:therapeutic use*; D006801:Humans; D007962:Leukocytes; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D014945:Wound Healing
chemical_list: D005337:Fibrin
keywords: autologous cell therapy; diabetic foot ulcer; healing; platelet-rich fibrin