LeucoPatch improves healing of difficult diabetic foot ulcers
medwireNews: Weekly application of an autologous immune cell, fibrin, and platelet patch (LeucoPatch) significantly increases the rate of healing of hard-to-heal foot ulcers compared with standard care in people with diabetes, randomized trial data show.
Frances Game (Derby Teaching Hospitals NHS Foundation Trust, UK) and co-investigators explain that the LeucoPatch system uses centrifugation without the need for additional reagents to generate a disc comprising autologous leucocytes, platelets, and fibrin, which is applied to the surface of the wound each week.
The researchers say that their study has demonstrated “the apparent effectiveness of this new intervention in the management of people with hard-to-heal diabetic foot ulcers.”
“It adds to the increasing number of studies that have reported benefit from the use of platelets and platelet-derived application to the surface of the chronic wound,” they write in The Lancet Diabetes & Endocrinology.
The study included 269 participants (mean age 62 years, 82% men) from 32 specialist diabetic foot clinics in the UK, Denmark, and Sweden who had hard-to-heal ulcers, defined as those with less than a 50% reduction of area in response to standard care during a 4-week run-in period.
After 20 weeks of treatment, patients randomly assigned to receive LeucoPatch plus standard care (n=132) were a significant 58% more likely to have healed ulcers compared with those assigned to standard care alone (n=137), with healing rates of 34% and 22%, respectively.
Ulcer healing was defined as complete epithelialization without drainage that was maintained for 4 weeks, as assessed by a trained observer who was blinded to treatment allocation.
The researchers also found that that time to healing was significantly shorter in the LeucoPatch group than in the standard care group, at 72 versus 84 days.
And although patients in the LeucoPatch group needed to give blood on a weekly basis to create the patch, there was no difference between the treatments in the rate of new anemia, nor was there any difference in the rate of adverse events.
The most common serious adverse event (SAE) was diabetic foot infection, which accounted for 24% of all SAEs in the LeucoPatch grop and 27% of those in the standard care group.
“In people with diabetes complicated by foot ulcers that are not healing despite best standard of care, this new bedside treatment has the potential to significantly accelerate wound healing,” Game and co-authors conclude.
However, the researchers also acknowledge that only 45% of the patients they screened were included in the study, which “might suggest that the patient population was not representative of patients seen in a specialist diabetic foot clinic.”
They say: “We felt that for this protocol, although we were including hard-to-heal ulcers, we had to exclude those with little chance of healing within the 20 weeks of the study (eg, very large ulcers, those with severe ischaemia, and those with severe renal disease) as their data had little chance of contributing to the final results.”
By Laura Cowen
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