title: Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers.
abstract: OBJECTIVE
  The purpose of this 16-week, multicenter, randomized, controlled trial was to assess the healed ulcer rate of a human acellular dermal matrix, DermACELL, compared with conventional care and a second acellular dermal matrix, Graftjacket, in the treatment of full-thickness diabetic foot ulcers.
  
  
  METHODS
  One hundred sixty-eight patients were randomized into DermACELL, conventional care, and Graftjacket treatment arms in a 2:2:1 ratio. Patients in the acellular dermal matrix groups received either 1 or 2 applications of the graft at the discretion of the investigator. Weekly follow-up visits were conducted until the ulcer healed or the endpoint was reached.
  
  
  RESULTS
  At 16 weeks, the DermACELL arm had a significantly higher proportion of completely healed ulcers than the conventional care arm (67.9% vs 48.1%; P = .0385) and a nonsignificantly higher proportion than the Graftjacket arm (67.9% vs 47.8%; P = .1149). The DermACELL arm also exhibited a greater average percent reduction in wound area than the conventional care arm (91.4% vs 80.3%; P = .0791) and the Graftjacket arm (91.4% vs 73.5%; P = .0762). The proportion of severe adverse events and the proportion of overall early withdrawals were similar among the 3 groups based on relative population size (P ≥ .05).
  
  
  CONCLUSIONS
  The results presented here indicate that DermACELL is an appropriate clinical option in the treatment of diabetic foot ulcers, with significant increases in healing rates and rate of percentage wound closure as compared with conventional care options.
authors.affiliation: Southern Arizona VA Health Care System, Tucson.
authors.forename: Jodi
authors.initials: J
authors.lastname: Walters
authors.affiliation: Limb Preservation Platform, Valley Vascular Surgical Associates, Fresno, Calif.
authors.forename: Shawn
authors.initials: S
authors.lastname: Cazzell
authors.affiliation: Boston University School of Medicine, Boston Medical Center, Boston, Mass.
authors.forename: Hau
authors.initials: H
authors.lastname: Pham
authors.affiliation: ILD Research Center, San Diego, Calif.
authors.forename: Dean
authors.initials: D
authors.lastname: Vayser
authors.affiliation: California School of Podiatric Medicine at Samuel Merritt University, Oakland; UCSF Center for Limb Preservation, San Francisco, Calif.
authors.forename: Alexander
authors.initials: A
authors.lastname: Reyzelman
keywords: DermACELL; acellular dermal matrix; allograft; diabetic foot ulcer; wound