Patch therapy improves healing of diabetic foot ulcers
A new patch comprising autologous leucocytes, platelets, and fibrin improved the healing rate of hard-to-heal foot ulcers among patients with diabetes compared with standard therapy, a recent study found.
Participants in this multinational (32 diabetic foot clinics in UK, Denmark, and Sweden) trial were 269 patients (mean age 61.9 years, 82 percent male) with diabetes (baseline HbA1c ≤12 percent; 83 percent with type 2 diabetes) and one or more non-infected, hard-to-heal foot ulcers. They were randomized to receive the intervention (weekly application of the LeucoPatch on the ulcer plus usual care [n=132]) or usual care alone (n=137) for 20 weeks. The patch was made at the bedside during weekly visits to the foot clinic, with the patient’s blood drawn into the patch device, spun for 20 minutes in a centrifuge, the three-layered patch removed, cut into an appropriate size, and placed on the ulcer.
A majority of patients (74 percent) had ulcers with an area >100 mm2, 87 percent had superficial ulcers, and 78 percent had ulcers affecting the total forefoot.
The proportion of ulcers healed was higher among patients who used the patch, with 34 percent of ulcers healed within 20 weeks compared with 22 percent among patients whose ulcers were treated with usual care (adjusted odds ratio, 1.58, 96 percent confidence interval [CI], 1.04–2.40; p=0.0235). [Lancet Diabetes Endocrinol 2018;doi:10.1016/S2213-8587(18)30240-7]
The ulcers that healed also did so in a shorter amount of time with the patch compared with usual care (hazard ratio, 1.709, 95 percent CI, 1.071–2.728; p=0.0246), with a significant reduction in ulcer area (p=0.0168).
Adverse event (AE) incidence was comparable between patients using the patch and those treated with usual care, as was the incidence of diabetic foot infection during the treatment period. Diabetic foot infection was the most frequently occurring serious AE (n=24 vs 20), with 16 and 12 infections in the patch and usual care groups, respectively, related to the index ulcer. The incidence of new cases of anaemia was also comparable between patients using the patch and those treated with usual care (10 percent vs 8 percent; p=0.6408). None of the AEs were deemed patch-related.
According to the researchers, the benefits conferred by platelets and platelet-based applications as seen in this and other studies could be mediated by inflammation and tissue repair mechanisms.
“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,” said the researchers. They also highlighted an added benefit, the lack of increase in anaemia events despite the weekly blood draws in the patients who used the patch.
“To avoid patients losing a leg to infection, the goal should be to heal ulcers as quickly as possible,” said Professor Michael Edmonds from King’s College Hospital in London, UK, in a commentary. [Lancet Diabetes Endocrinol 2018;doi:10.1016/S2213-8587(18)30262-6]
“[I]t is hoped that this renaissance in diabetic foot care will usher in a new age of enlightenment in the study of the basic and clinical science of diabetic foot ulcers, finally eradicating the major amputations that result from complications of unhealed foot ulcers,” he said.
Edmonds also suggested that revascularization, which was only done in 3 percent of the participants, may have improved ulcer healing, and pointed out the importance of infection prevention due to its effect on infective necrosis and major amputation.