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

• Published in: Diabetes (New York, N.Y.) Vol. 67; no. Supplement_1
• Main Authors: Game, Frances, Jeffcoate, William, Tarnow, Lise, Jacobsen, Judith L, Whitham, Diane J, Harrison, Eleanor F, Ellender, Sharon J, Londahl, Magnus
• Format: Journal Article
• Language: English
• Published: New York American Diabetes Association 01.07.2018
• Subjects: Centrifugation; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Disease management; Feet; Fibrin; Foot diseases; Leg ulcers; Leukocytes; Motivation; Ulcers; Wound healing
• ISSN: 0012-1797; 1939-327X
• DOI: 10.2337/db18-638-P

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.