September 26, 2018
By Reuters Staff\
NEW YORK (Reuters Health) - A new system that uses a multi-layer patch made with a patient's own leukocytes, platelets and fibrin can speed the healing of diabetic foot ulcers, according to new findings.
"The use of LeucoPatch is associated with significant enhancement of healing of hard-to-heal foot ulcers in people with diabetes," Dr. Frances Game of Derby Teaching Hospitals NHS Foundation Trust in the U.K. and colleagues conclude in The Lancet Diabetes & Endocrinology, online September 19 report.
To date, Dr. Game and her team note, studies of the effectiveness of treatments for diabetic foot ulcer have not followed established criteria for trial design or reporting, and trials of blood-derived products to aid healing have had mixed results.
The LeucoPatch (Reapplix ApS, Birkeroed, Denmark) is made with centrifugation at the patient's bedside, with no reagents needed. After two pilot studies showed promising results, the authors conducted an observer-masked, randomized controlled trial at 32 diabetic foot clinics in the U.K., Denmark and Sweden.
Patients whose ulcer area was reduced by less than 50% after the four-week run-in period of standard care were randomized to continue standard care with or without weekly LeukoPatch application.
The intention-to-treat (ITT) population included 132 patients in the LeucoPatch group and 134 in the standard-care group. At 20 weeks, 34% of the ulcers had healed in the LeucoPatch group, versus 22% of the standard-care group. The adjusted odds ratio for healing with the LeucoPatch was 1.58 (P=0.02).
Median time to healing was 72 days with the LeucoPatch and 84 days without it (P=0.03).
There were no significant differences between the two groups in the incidence of diabetic-foot infection, minor or major amputation, or new-onset anemia.
"Although reviews of the published literature on wound care products for diabetic foot ulcers have repeatedly emphasized the urgent need for trials of better quality, to our knowledge, this trial is only the third relatively robust randomized controlled trial to be reported in the last 12 months," the authors note.
One of these studies, Explorer (https://bit.ly/2zvRimc), tested a sucrose octasulfate, while the other, ProNOx1 (https://bit.ly/2QYS161), looked at a dressing that releases nitric oxide intradermally.
"Although these three studies represent contrasting modes of action, and include different types of ulcer with different durations and healing criteria, all three trials reported an almost identical figure for unadjusted OR: about 1.5-1.6," the researchers write.
In an accompanying editorial, Dr. Michael Edmonds of the Diabetic Foot Clinic at King's College Hospital in London, U.K., notes that the patch did not appear to reduce the risk of diabetic-foot infection.
"Despite patients being under weekly supervision during the trial, new episodes of infection developed, which was also true in the Explorer and ProNOx1 trials," he adds. Dr. Edmonds was first author on both trials.
"To avoid patients losing a leg to infection, the goal should be to heal ulcers as quickly as possible," he writes. "The three studies that have described interventions that significantly improve healing, compared with the relatively low rates of healing with usual therapy, should contribute to this aim."
"Furthermore, it 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," Dr. Edmonds concludes.
Dr. Game was not available for an interview by press time.
SOURCE: https://bit.ly/2xF1hnQ and https://bit.ly/2Ik399R
Lancet Diabetes Endocrinol 2018.
(c) Copyright Thomson Reuters 2018. Click For Restrictions - https://agency.reuters.com/en/copyright.html
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