Graftskin, a Human Skin Equivalent, Is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers

DOI PDF 被引用文献14件
  • Aristidis Veves
    From the Joslin-Beth Israel Deaconess Foot Center and Harvard Medical School (A.V.), Boston, Massachusetts; the Department of Dermatology and Skin Surgery (V.F.), Roger Williams Medical Center, Providence, Rhode Island; the Boston University School of Medicine (V.F.), Boston, Massachusetts; the Department of Surgery (D.G.A.), Southern Arizona Veterans Affairs Medical Center, Tucson, Arizona; and Organgenesis (M.L.S.), Canton,Massachusetts.
  • Vincent Falanga
    From the Joslin-Beth Israel Deaconess Foot Center and Harvard Medical School (A.V.), Boston, Massachusetts; the Department of Dermatology and Skin Surgery (V.F.), Roger Williams Medical Center, Providence, Rhode Island; the Boston University School of Medicine (V.F.), Boston, Massachusetts; the Department of Surgery (D.G.A.), Southern Arizona Veterans Affairs Medical Center, Tucson, Arizona; and Organgenesis (M.L.S.), Canton,Massachusetts.
  • David G. Armstrong
    From the Joslin-Beth Israel Deaconess Foot Center and Harvard Medical School (A.V.), Boston, Massachusetts; the Department of Dermatology and Skin Surgery (V.F.), Roger Williams Medical Center, Providence, Rhode Island; the Boston University School of Medicine (V.F.), Boston, Massachusetts; the Department of Surgery (D.G.A.), Southern Arizona Veterans Affairs Medical Center, Tucson, Arizona; and Organgenesis (M.L.S.), Canton,Massachusetts.
  • Michael L. Sabolinski
    From the Joslin-Beth Israel Deaconess Foot Center and Harvard Medical School (A.V.), Boston, Massachusetts; the Department of Dermatology and Skin Surgery (V.F.), Roger Williams Medical Center, Providence, Rhode Island; the Boston University School of Medicine (V.F.), Boston, Massachusetts; the Department of Surgery (D.G.A.), Southern Arizona Veterans Affairs Medical Center, Tucson, Arizona; and Organgenesis (M.L.S.), Canton,Massachusetts.

抄録

<jats:p>OBJECTIVE— We assessed in a randomized prospective trial the effectiveness of Graftskin, a living skin equivalent, in treating noninfected nonischemic chronic plantar diabetic foot ulcers.</jats:p> <jats:p>RESEARCH DESIGN AND METHODS— In 24 centers in the U.S., 208 patients were randomly assigned to ulcer treatment either with Graftskin (112 patients) or saline-moistened gauze (96 patients, control group). Standard state-of-the-art adjunctive therapy, which included extensive surgical debridement and adequate foot off-loading, was provided in both groups. Graftskin was applied at the beginning of the study and weekly thereafter for a maximum of 4 weeks (maximum of five applications) or earlier if complete healing occurred. The major outcome of complete wound healing was assessed by intention to treat at the 12-week follow-up visit.</jats:p> <jats:p>RESULTS— At the 12-week follow-up visit, 63 (56%)Graftskin-treated patients achieved complete wound healing compared with 36(38%) in the control group (P = 0.0042). The Kaplan-Meier median time to complete closure was 65 days for Graftskin, significantly lower than the 90 days observed in the control group (P = 0.0026). The odds ratio for complete healing for a Graftskin-treated ulcer compared with a control-treated ulcer was 2.14 (95% CI 1.23-3.74). The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis and lower-limb amputations, both of which were less frequent in the Graftskin group.</jats:p> <jats:p>CONCLUSIONS— Application of Graftskin for a maximum of 4 weeks results in a higher healing rate when compared with state-of-the-art currently available treatment and is not associated with any significant side effects. Graftskin may be a very useful adjunct for the management of diabetic foot ulcers that are resistant to the currently available standard of care.</jats:p>

収録刊行物

  • Diabetes Care

    Diabetes Care 24 (2), 290-295, 2001-02-01

    American Diabetes Association

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