Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study
| Autor: | R Lundquist, Tonny Karlsmark, Lise Tarnow, B. Jorgensen, A Nilsson, M Michelsen, M Zakrzewski, Anette Mertz Nielsen, Magnus Löndahl |
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| Rok vydání: | 2015 |
| Předmět: |
Blood Platelets
Male medicine.medical_specialty Nursing (miscellaneous) Pilot Projects Fibrin Cohort Studies Leukocytes medicine Clinical endpoint Humans Prospective Studies Prospective cohort study Aged Wound Healing biology business.industry Venous blood Middle Aged medicine.disease Diabetic foot Diabetic Foot Platelet-rich fibrin Surgery Diabetic foot ulcer biology.protein Female Fundamentals and skills business Wound healing |
| Zdroj: | Journal of Wound Care. 24:172-178 |
| ISSN: | 2052-2916 0969-0700 |
| DOI: | 10.12968/jowc.2015.24.4.172 |
| Popis: | 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 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. Conclusion: 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. Declaration of interest: M.L and L.T have received consultation fees from Reapplix A/S. R.L. is co-inventor of the Leucopatch technology. All other authors declare no duality of interest associated with this manuscript. This study was financed by Reapplix A/S. Time to data analysis and manuscript preparations have been financed by Medical Faculty (ALF), Lund University, Lund Sweden. |
| Databáze: | OpenAIRE |
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