Treatment of Diabetic Foot Ulcers with Dehydrated Human Amnion/chorion Membrane* (dHACM): Significant RCT Results

Purpose: The aim of this presentation is to present compelling evidence that dehydrated human amnion/chorion membrane (dHACM) can substantially impact the healing and closure of diabetic foot ulcers (DFUs) as an adjunct to best practice multicomponent DFU therapy.

Methods: Multiple randomized controlled trials involving dHACM as a treatment component in DFU care have all demonstrated statistically significant improvements in wound healing kinetics and complete closure in patients with chronic non-healing wounds.

Results: An early pilot RCT with a limited number of patients demonstrated over 92% healing of patients treated with dHACM versus control at six weeks, with both groups receiving major elements of standard of care including regular sharp debridement, a moist environment, and offloading. Confirmatory results were demonstrated in other controlled studies using weekly vs biweekly application, and against a leading industry competitor tissue substitute.  Most recently, a large, multicenter study again demonstrated statistically significant healing rates in a group of over 100 patients, with 70% closure rates by 12 weeks. 

Conclusions: Amniotic membrane has been documented as a viable therapy for the treatment of chronic wounds since the early 20th century.  Problems with sourcing and preservation of this material have made regular use problematic.  Recent developments in processing this material have resulted in the creation of an ambient temperature-stable material that can be easily applied in a number of venues.  Now the most commonly used skin substitute in the United States, dHACM represents a noteworthy development in the contemporary treatment of DFUs.

*dHACM = EpiFix®, MiMedx Group Inc., Marietta, GA