With the LeucoPatch – which contained study participants’ own cells (platelets, fibrin, and leukocytes) – 34.1% of ulcers healed within 20 weeks versus 21.6% of ulcers that were treated using the best standard care (unadjusted odds ratio, 1.58; 95% confidence interval, 1.06-2.25; P = .02). Healing was defined as complete epithelialization maintained for 4 weeks, as confirmed by an observer blinded to the treatment group.
Results remained significant after adjusting for baseline wound size (adjusted OR 1.89; P = .02) and following a per-protocol analysis (aOR, 1.75; P = .048).
Furthermore, time to healing was shorter in the intervention group (P = .02), lead study investigator Frances Game, MD, of the Derby (England) Teaching Hospitals National Health Service Foundation Trust, reported at the annual meeting of the European Association for the Study of Diabetes.
“Successive systematic reviews from the International Working Group of the Diabetic Foot have shown that there’s very poor evidence for many of the things that we do in day-to-day practice,” she said.
“Having said that, there have been some positive studies using platelets or platelet-rich plasma to improve healing of the diabetic foot,” Dr. Game noted, although results have been inconsistent. From this the idea of the LeucoPatch was born. This is an autologous active cell therapy, which according to the Danish company Reapplix that markets it, helps patients “heal themselves.”
The LeucoPatch system is made by taking 18 mL of a patient’s blood and spinning the collection tube in a centrifuge for 20 minutes to generate a three-layered disc that contains fibrin, platelets, and leukocytes. This can then be applied to the surface of the diabetic foot ulcer. Dr. Game noted that 18 mL of blood will make a 5-cm patch and more than one patch can be made from the blood sample.
“It looks like a bit of wet skin when it comes out of the centrifuge and you just put it on sole side down. It’s taking the patient’s own cells, that often aren’t getting to the ulcer because of the morbidity of the patient and vascular disease, and actually putting them where they need to be,” she explained. The patch usually becomes absorbed within a week; depending on the ulcer, reapplication may be required.
“It’s quite a straightforward procedure that’s performed the bedside,” Dr. Game observed. “That’s how we were able to recruit so many patients, as it’s quite simple.” Indeed, almost 600 people with diabetic foot ulcers agreed to participate in the study, but only those with difficult-to-treat ulcers were included after a 4-week run-in period. The 269 patients who were finally randomized were treated at 32 specialist diabetic foot clinics in the United Kingdom, Denmark, and Sweden.
The majority of participants were male (82%) and had type 2 diabetes mellitus (83%). The mean age was 62 years and the median duration of diabetes was 16 years. The mean ulcer area was 240 mm2, with 87% being superficial, 10% reaching down to the tendon, and 3% down to the bone. In 78% of cases, the total forefoot was affected, with the plantar forefoot and hind foot affected in a respective 42% and 22% of cases.
The LeucoPatch system is already being used in several European countries, including Germany and Belgium, Dr. Game noted. However, this is the first randomized, controlled trial to demonstrate a clinical and statistically significant benefit. The data show that the weekly application of LeucoPatch is clearly of benefit in a population of patients with hard-to-heal diabetic foot ulcers.
“The low drop-out numbers suggest a good patient acceptability,” she noted, and “the treatment was without apparent increase in adverse events, particularly without evidence of new onset anemia.”
Cost-effectiveness data were collected throughout the study and will be available at a future date when these have been analyzed, Dr. Game said.
The LeucoPatch system received Food and Drug Administrationin .
The research was published online in the Lancet Diabetes & Endocrinology ahead of the presentation.
The trial was funded by Reapplix. Dr. Game reported receiving research funding from the company.
SOURCES: Game F et al. EASD 2018 .