title: The incidence of lower-extremity amputation and bone resection in diabetic foot ulcer patients treated with a human fibroblast-derived dermal substitute.
abstract: OBJECTIVE
  Diabetic foot ulcers (DFUs) are frequently recalcitrant and at risk for infection, which may lead to lower-extremity amputation or bone resection. Reporting the incidence of amputations/bone resections may shed light on the relationship of ulcer healing to serious complications. This study aimed to evaluate the incidence of amputations/bone resections in a randomized controlled trial comparing human fibroblast-derived dermal substitute plus conventional care with conventional care alone for the treatment of DFUs.
  
  
  METHODS
  Ulcer-related amputation/bone resection data were extracted from data on all adverse events reported for the intent-to-treat population (N = 314), and amputations were categorized by type: below the knee, Syme, Chopart, transmetatarsal, ray, toe, or partial toe. Data were analyzed retrospectively for the incidence of amputation/bone resection by treatment.
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  Patients with full-thickness DFUs greater than 6 weeks' duration.
  
  
  METHODS
  Standard wound care plus human fibroblast-derived dermal substitute versus standard wound care alone.
  
  
  RESULTS
  The incidence of amputation/bone resection in the study was 8.9% (28/314) overall, 5.5% (9/163) for patients receiving human fibroblast-derived dermal substitute, and 12.6% (19/151) for patients receiving conventional care (P = .031). Of the 28 cases of amputation/bone resection, 27 were preceded by ulcer-related infection.
  
  
  CONCLUSIONS
  There were significantly fewer amputations/bone resections in patients who received human fibroblast-derived dermal substitute versus conventional care, likely related to the lower incidence of infection adverse events observed in the human fibroblast-derived dermal substitute treatment group.
authors.affiliation: Robert G. Frykberg, DPM, MPH, is Chief of Podiatry and Residency Director, Phoenix VA Healthcare System, Phoenix, Arizona. William A. Marston, MD, is Medical Director, Department of Surgery, Division of Vascular Surgery, University of North Carolina Wound Healing Center, Chapel Hill, North Carolina. Matthew Cardinal, MS, is Clinical Research Scientist, Novartis Vaccines & Diagnostics, Boston, Massachusetts. Dr Frykberg has disclosed that he has received research funding from Shire Regenerative Medicine, a previous manufacturer of Dermagraft, and previously received honoraria for lectures on diabetic foot ulcers from Shire Regenerative Medicine. Dr Marston has disclosed that he has served as a scientific consultant to Shire Regenerative Medicine. Mr Cardinal has disclosed that he was an employee of Shire Regenerative Medicine at the time the manuscript was developed. The views expressed herein are those of the authors and neither those of the Department of Veterans Health Affairs, nor the US Government. Shire Regenerative Medicine provided technical writing support in the development of this manuscript. An abstract of this work was presented at the Wound Healing Society's annual meeting April 20, 2012. Abstract citation: Frykberg RG, Marston WA, Cardinal M. Wound Rep Reg 2012;20:A23.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Frykberg
authors.forename: William A
authors.initials: WA
authors.lastname: Marston
authors.forename: Matthew
authors.initials: M
authors.lastname: Cardinal
mesh_terms: D000671:Amputation, Surgical / Q000706:statistics & numerical data*; D020099:Coated Materials, Biocompatible; D017719:Diabetic Foot / Q000601:surgery*; D005260:Female; D005347:Fibroblasts; D006801:Humans; D008297:Male; D012189:Retrospective Studies; D017768:Skin, Artificial
chemical_list: D020099:Coated Materials, Biocompatible; C512800:TransCyte