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November 15, 2018
The primary study outcome was the proportion of ulcers that healed within 20 weeks evaluated in the intention-to-treat population.
In patients with diabetes who have hard-to-heal foot ulcers, a clinically and statistically significant benefit has been associated with the weekly application of autologous leukocytes, fibrin, and platelet patches (LeucoPatch), according to the results of a multicenter, randomized, controlled trial (ClinicalTrials.gov identifier: NCT02224742) published in The Lancet Diabetes & Endocrinology.
The investigators sought to examine the effectiveness of LeucoPatch for the management of hard-to-heal foot ulcers among individuals with diabetes. This international study was conducted in 32 specialist diabetic foot clinics in 3 countries — the United Kingdom, Denmark, and Sweden. Following a 4-week run-in period, patients with a decrease in ulcer area of <50% were randomly assigned in a 1:1 ratio to either prespecified good care alone or care plus weekly application of LeucoPatch.
The primary study outcome was the proportion of ulcers that healed within 20 weeks evaluated in the intention-to-treat population, which was defined as complete epithelialization (ie, wound healing), and that remained healed for 4 weeks. Secondary patient-related outcomes included incidence of major (above the ankle) amputation affecting the target link (by 12, 20, and 26 weeks), incidence of major amputation affecting the contralateral limb (by 26 weeks), incidence of minor (below the ankle) amputation affecting the target limb (by 12, 20, and 26 weeks), incidence of minor amputation affecting the contralateral limb (by 26 weeks), incidence of new anemia, and decrease in quality of life of >10% from baseline.
A total of 269 participants were randomly assigned between August 30, 2013, and May 3, 2017, to receive treatment with either standard care (n=137) or LeucoPatch (n=132). Mean patient age was 61.9 ± 11.6 years. Overall, 82% of the participants were men and 83% had type 2 diabetes. In the LeucoPatch arm, 34% (45 of 132) of ulcers healed within 20 weeks, compared with 22% (29 of 134) of ulcers in the standard care arm (odds ratio 1.58; 95% CI, 1.04-2.40; P =.0235), based on intention-to-treat analysis.
Time to healing of ulcers was significantly shorter in the LeucoPatch group than in the standard care group (P =.0246). There was no difference in adverse events reported between the 2 treatment arms. Specifically, the use of LeucoPatch was not associated with new-onset anemia. The most common serious adverse event was diabetic foot infection (24 events in the LeucoPatch arm vs 20 in the standard care arm).
The investigators concluded that in individuals with diabetes who experience refractory foot ulcers, treatment with LeucoPatch has the potential to accelerate wound healing significantly.
Reference
Game F, Jeffcoate W, Tarnow L, et al; LeucoPatch II trial team. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial. Lancet Diabetes Endocrinol. 2018;6(11):870-878.
