New research published in September in Lancet Diabetes and Endocrinology describes the challenges associated with treating stubborn, difficult-to-heal diabetic foot ulcers. Lead author Frances L. Game, professor in the Department of Diabetes and Endocrinology, Derby Teaching Hospitals NHS Foundation Trust, Derby, United Kingdom, and her team explored the benefit of employing a disc made of the patient’s own platelets, fibrin, and leukocytes that is applied once weekly to heal the foot ulcers.

Although patients had to give blood in order to create the disc, which was prepared at bedside through centrifugation without additional chemical reagents, no additional adverse effects were seen compared with patients receiving standard-care interventions. The researchers found that that time to healing was significantly shorter in the LeucoPatch group—72 versus 84 days—than in the standard-care group.

This study was an international randomized, controlled trial including 32 diabetic foot ulcer clinics in the U.K., Denmark, and Sweden that evaluated 269 individuals diagnosed with diabetes and experiencing hard-to-heal foot ulcers. Patients were randomly allocated to receive either standard care alone or care plus weekly application of the LeucoPatch. The mean age was 61.9 years, 82% were men, and 83% had type 2 diabetes. In the LeucoPatch group, 34% of 132 ulcers healed within 20 weeks versus 22% of 134 ulcers in the standard-care group (odds ratio 1.58, 96% CI 1.04-2.40; P = .0235). No difference in adverse events was seen between the groups, and the most common serious adverse event (SAE) was diabetic foot infection (24% of all SAEs reported).

According to Professor Game, “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,” she and her coauthors conclude. The authors acknowledge limitations of the study, noting that not everyone screened made it into the study, and thus their study population may not be fully representative of the patients seen daily in diabetic foot ulcer clinics.

“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 ischemia, and those with severe renal disease) as their data had little chance of contributing to the final results,” said Professor Game in a recent interview.

 « Click here to return to Diabetes Update.