Investigators are reporting high healing rates with dehydrated human amniotic membrane allografts (EpiFix®, MiMedx Group Inc., Marietta, GA) for the treatment of chronic diabetic foot ulcers.
Their data, presented at the Symposium on Advanced Wound Care/Wound Healing Society Spring 2014, also show that wounds treated with weekly application heal nearly twice as fast as wounds treated with biweekly application.
"The findings are important because rapid healing of diabetic foot ulcers may cut clinical operational costs and prevent the development of long-term medical complications," Dr. Charles M. Zelen, a podiatrist with Professional and Education and Research Institute Inc. in Roanoke, VA, said.
For the study, investigators randomized 40 patients to receive weekly or biweekly application of the allograft following surgical debridement of all necrotic tissue. All patients also underwent a standard protocol of wound care involving non-adherent, moist dressing with compressive wrapping. All wounds were offloaded.
Participants had a history of type 1 or 2 diabetes and presented for treatment of a non-infected diabetic foot ulcer located anywhere on the foot of more than 4 weeks duration.
Over 90% of foot ulcers completely healed
Diabetic foot ulcers are increasingly common with the growing prevalence of diabetes, Dr. Zelen said. Importantly, the longer an ulcer remains open, the greater the likelihood of more serious complications such as cellulitis or osteomyelitis and, in turn, physician visits, hospitalization, and/or amputation.
Overall, 92.5% of foot ulcers completely healed during the 12-week study period. The mean time to complete healing was 2.4 weeks for weekly application of the allograft compared with 4.1 weeks for biweekly application.
The number of allografts applied to healed wounds was similar in the weekly and biweekly cohorts (2.4 and 2.3 allografts, respectively).
Dr. Zelen emphasized that the study sample included individuals who are representative of the types of patients typically seen by clinicians in the community setting.
He said that the results need to be confirmed in large multi-center clinical studies with the inclusion of a longer follow-up period in order to validate the durability of healed wounds.
Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer