title: A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer.
abstract: Delayed closure of foot ulcers is a primary factor leading to lower extremity amputation in patients with diabetes, creating great demand for products or therapies to accelerate the rate of wound closure in this population. This study (ClinicalTrials.gov Identifier: NCT02209051) was designed to evaluate dehydrated amniotic membrane allograft (DAMA) (AMNIOEXCEL, Derma Sciences Inc, Princeton, NJ) plus standard of care (SOC) compared to SOC alone for the closure of chronic diabetic foot ulcers (DFUs).
  
  
  METHODS
  This prospective, open-label, randomized, parallel group trial was implemented at 8 clinical sites in the United States. Eligibility criteria included adults with type 1 or type 2 diabetes mellitus who have 1 or more ulcers with a Wagner classification of grade 1 or superficial 2 measuring between 1 cm2 and 25 cm2 in area, presenting for more than 1 month with no signs of infection/osteomyelitis; ABI > 0.7; HbA1c Less than 12%; and serum creatinine less than 3.0 mg/dL. Eligible subjects were randomized (1:1) to receive either SOC alone (n = 14) or DAMA+SOC (n = 15) until wound closure or 6 weeks, whichever occurred first. The endpoint was the proportion of subjects with complete wound closure (defined as complete reepithelialization without drainage or need for dressings).
  
  
  RESULTS
  Thirty-five percent of subjects in the DAMA+SOC cohort achieved complete wound closure at or before week 6, compared with 0% of the SOC alone cohort (intent-to-treat population, P = 0.017). There was a more robust response noted in the per protocol population, with 45.5% of subjects in the DAMA+SOC cohort achieving complete wound closure, while 0% of SOC-alone subjects achieved complete closure (P = 0.0083). No treatment-related adverse events were reported.
  
  
  CONCLUSIONS
  The results suggest DAMA is safe and effective in the management of DFUs, but additional research is needed.
authors.affiliation: Barry University Clinical Research, North Miami Beach, FL.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Snyder
authors.affiliation: Pacific Wound Center, Stockton, CA;
authors.forename: Kenneth
authors.initials: K
authors.lastname: Shimozaki
authors.affiliation: Associated Foot and Ankle Specialists, Phoenix, AZ.
authors.forename: Arthur
authors.initials: A
authors.lastname: Tallis
authors.affiliation: Duke University Medical Center, Durham, NC.
authors.forename: Michael
authors.initials: M
authors.lastname: Kerzner
authors.affiliation: Center for Clinical Research, San Francisco, CA.
authors.forename: Alexander
authors.initials: A
authors.lastname: Reyzelman
authors.affiliation: Wayne Memorial Wound Healing and Hyperbaric Center, Goldsboro, NC.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Lintzeris
authors.affiliation: First Coast Cardiovascular Institute, Jacksonville, FL.
authors.forename: Desmond
authors.initials: D
authors.lastname: Bell
authors.affiliation: Derma Sciences Inc, Princeton, NJ.
authors.forename: Randi L
authors.initials: RL
authors.lastname: Rutan
authors.affiliation: Beth Israel Deaconess Hospital, Plymouth, MA.
authors.forename: Barry
authors.initials: B
authors.lastname: Rosenblum
mesh_terms: D064591:Allografts; D001684:Biological Dressings; D003094:Collagen; D017719:Diabetic Foot / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D011446:Prospective Studies; D017768:Skin, Artificial; D059039:Standard of Care; D016896:Treatment Outcome; D014481:United States; D014945:Wound Healing
chemical_list: C117898:Apligraf; D003094:Collagen