A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics.
Diabetic foot complications (infections, gangrene or open wounds) are common causes of amputations and disability among diabetic patients.
Dr. Tettelbach and Coll conducted this prospective, randomized, controlled and multicentre clinical trial. The scope of this study was to evaluate the healing outcomes in diabetic patients with chronic lower extremity ulcers treated with a weekly application of dHACM. The study was conducted involving 14 wound care centers in the United State of America.
A total of 110 patients were included. Fifty-four patients were included in the dHACM group and 56 patients were included in the no-dHACM group. Ninety-eight patients completed the study. Forty-seven patients received dHACM treatment, while 51 patients didn’t receive dHACM.
Complete re-epithelialization of the wound was used as the definition for complete healing.
At the end of the 12-week treatment phase, 70% (38/54) of dHACM-treated ulcers had completely healed, while 50% (28/56) of healed ulcers in the no-dHACM group healed completely.
At the final follow up at 16 weeks, 95% of dHACM-healed ulcers and 86% of healed ulcers in the no-dHACM group remained closed
These results confirm that dHACM is an efficacious treatment for lower extremity ulcers in a heterogeneous patient population reducing the time to complete the healing process.
Tettelbach W, Cazzell S, Reyzelman AM, Sigal F, Caporusso JM, Agnew PS. Int Wound J. 2019 Feb;16(1):19-29.