title: Use of dermagraft, a cultured human dermis, to treat diabetic foot ulcers.
abstract: OBJECTIVE
  To assess the effect of a tissue-engineered human dermis (Dermagraft) in healing diabetic foot ulcers.
  
  
  METHODS
  This controlled prospective multicenter randomized single-blinded pilot study evaluated healing over a 12-week period in 50 patients with diabetic foot ulcers. These patients were randomized into four groups (three different dosage regimens of Dermagraft and one control group). All patients received identical care except for the use of Dermagraft tissue. Ulcer healing was assessed by percentage of wounds achieving complete or 50% closure, time to complete or 50% closure, and volume and area measurements.
  
  
  RESULTS
  Ulcers treated with the highest dosage of Dermagraft, one piece applied weekly for 8 weeks (group A), healed significantly more often than those treated with conventional wound closure methods; 50% (6 of 12) of the Dermagraft-treated and 8% (1 of 13) of the control ulcers healed completely (P = 0.03). The percentage of wounds achieving 50% closure was also significantly higher (75 vs. 23%; P = 0.018), and the time to complete or 50% closure was faster (P = 0.056). The group A regimen was more effective than other treatment regimens. All three were better than the control, however, and a dose-response was observed. There were no safety concerns. After a mean of 14 months of follow-up (range 11-22 months), there were no recurrences in the Dermagraft-healed ulcers.
  
  
  CONCLUSIONS
  Dermagraft was associated with more complete and rapid healing in diabetic foot ulcers. The recurrence data may indicate an improved quality of wound healing.
authors.affiliation: Advanced Tissue Sciences, Inc., La Jolla, CA 92037, USA.
authors.forename: G D
authors.initials: GD
authors.lastname: Gentzkow
authors.forename: S D
authors.initials: SD
authors.lastname: Iwasaki
authors.forename: K S
authors.initials: KS
authors.lastname: Hershon
authors.forename: M
authors.initials: M
authors.lastname: Mengel
authors.forename: J J
authors.initials: JJ
authors.lastname: Prendergast
authors.forename: J J
authors.initials: JJ
authors.lastname: Ricotta
authors.forename: D P
authors.initials: DP
authors.lastname: Steed
authors.forename: S
authors.initials: S
authors.lastname: Lipkin
mesh_terms: D000368:Aged; D017719:Diabetic Foot / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D009779:Occlusive Dressings; D018579:Patient Selection; D011446:Prospective Studies; D016037:Single-Blind Method; D012867:Skin; D014945:Wound Healing