Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study

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). Method: Non-ischaemic Wagner grade 1 or 2 DFUs with a duration of more than 6 weeks and a maximal area of 10cm(2) 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. Conclusion: The leucocyte patch is well-tolerated, easy to use and has potential in the arnnamentarium of the DFU treatment, provided this outcome is confirmed in an appropriately powered randomised clinical trial.