title: The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial.
abstract: OBJECTIVE
  To determine if a human fibroblast-derived dermal substitute could promote the healing of diabetic foot ulcers.
  
  
  METHODS
  A randomized, controlled, multicenter study was undertaken at 35 centers throughout the U.S. and enrolled 314 patients to evaluate complete wound closure by 12 weeks. Patients were randomized to either the Dermagraft treatment group or control (conventional therapy). Except for the application of Dermagraft, treatment of study ulcers was identical for patients in both groups. All patients received pressure-reducing footwear and were allowed to be ambulatory during the study.
  
  
  RESULTS
  The results demonstrated that patients with chronic diabetic foot ulcers of >6 weeks duration experienced a significant clinical benefit when treated with Dermagraft versus patients treated with conventional therapy alone. With regard to complete wound closure by week 12, 30.0% (39 of 130) of Dermagraft patients healed compared with 18.3% (21 of 115) of control patients (P = 0.023). The overall incidence of adverse events was similar for both the Dermagraft and control groups, but the Dermagraft group experienced significantly fewer ulcer-related adverse events.
  
  
  CONCLUSIONS
  The data from this study show that Dermagraft is a safe and effective treatment for chronic diabetic foot ulcers.
authors.affiliation: University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7212, USA. sky@med.unc.edu
authors.forename: William A
authors.initials: WA
authors.lastname: Marston
authors.forename: Jason
authors.initials: J
authors.lastname: Hanft
authors.forename: Paul
authors.initials: P
authors.lastname: Norwood
authors.forename: Richard
authors.initials: R
authors.lastname: Pollak
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015925:Cryopreservation; D017719:Diabetic Foot / Q000628:therapy*; D005260:Female; D005347:Fibroblasts / Q000166:cytology; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D015203:Reproducibility of Results; D012449:Safety; D012775:Shoes; D017768:Skin, Artificial / Q000009:adverse effects / Q000592:standards*