The Leucopatch® System in the Management of Hard-to-Heal Diabetic Foot Ulcers—A Multicentre, Multinational, Observer-Blinded, Randomised Controlled Trial

Abstract

Background: The LeucoPatch® device uses bedside centrifugation without additional reagents to generate a disc comprising autologous platelets, fibrin and leucocytes which is applied to the surface of the wound. The aim of the study was to test the effectiveness of LeucoPatch® on the healing of hard-to-heal foot ulcers in people with diabetes. Methods: 595 people with diabetes and a foot ulcer consented to participate. After a 4 week run-in-period those with a reduction in ulcer area of < 50% were randomised to either pre-specified good standard care alone or care supplemented by weekly application of LeucoPatch®. The primary outcome was percentage of ulcers healed within 20 weeks, defined as complete epithelialisation confirmed by an observer blind to randomisation group and maintained for four weeks. Results: 269 people were randomised; mean age 62 years, 82% male, 82% type 2 diabetes. In the intervention group 34.1% (n=45/132) of ulcers healed within 20 weeks vs. 21.6% (n=29/134) of the controls (OR 1.58, 95% CI 1.06-2.35; p= 0.02) by intention-to-treat analysis. Time to healing was shorter in the intervention group (p=0.0246) (Figure). No difference in adverse events was seen between groups. Interpretation: The use of LeucoPatch® is associated with significant enhancement of healing of hard-to heal foot ulcers in people with diabetes. Disclosure F. Game: Research Support; Self; Reapplix aps. W. Jeffcoate: Research Support; Self; Reapplix Aps, Urgo, France. L. Tarnow: Stock/Shareholder; Self; Novo Nordisk A/S. J.L. Jacobsen: Consultant; Self; Reapplix. D.J. Whitham: Other Relationship; Self; Reapplix. E.F. Harrison: Research Support; Self; Reapplix. S.J. Ellender: None. M. Londahl: Speaker's Bureau; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company. Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; ReApplix AS.

Diabetic Foot Syndrome

“…The wound surface should be thoroughly cleaned at each dressing change. The choice of dressing in an individual case should be based on wound size, exudate volume, presence or absence of signs of infection, available evidence 6 7 8 9 10 and cost-effectiveness criteria.…”

Diabetisches Fußsyndrom

“…Die Wundoberfläche ist bei jedem Verbandwechsel gründlich zu reinigen. Die Auswahl der Wundauflage im individuellen Fall sollte anhand der Wundausdehnung, der Exsudatmenge, des Vorliegens oder Fehlens von Infektionszeichen, der vorliegenden Evidenz 6 7 8 9 10 sowie anhand von Kosteneffektivitätskriterien getroffen werden.…”