title: Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial.
abstract: OBJECTIVE
  Hyperbaric oxygen therapy (HBOT) is used for the treatment of chronic diabetic foot ulcers (DFUs). The controlled evidence for the efficacy of this treatment is limited. The goal of this study was to assess the efficacy of HBOT in reducing the need for major amputation and improving wound healing in patients with diabetes and chronic DFUs.
  
  
  METHODS
  Patients with diabetes and foot lesions (Wagner grade 2-4) of at least 4 weeks' duration participated in this study. In addition to comprehensive wound care, participants were randomly assigned to receive 30 daily sessions of 90 min of HBOT (breathing oxygen at 244 kPa) or sham (breathing air at 125 kPa). Patients, physicians, and researchers were blinded to group assignment. At 12 weeks postrandomization, the primary outcome was freedom from meeting the criteria for amputation as assessed by a vascular surgeon. Secondary outcomes were measures of wound healing.
  
  
  RESULTS
  One hundred fifty-seven patients were assessed for eligibility, with 107 randomly assigned and 103 available for end point adjudication. Criteria for major amputation were met in 13 of 54 patients in the sham group and 11 of 49 in the HBOT group (odds ratio 0.91 [95% CI 0.37, 2.28], P = 0.846). Twelve (22%) patients in the sham group and 10 (20%) in the HBOT group were healed (0.90 [0.35, 2.31], P = 0.823). All other indices of wound healing were also not statistically significantly different between groups.
  
  
  CONCLUSIONS
  HBOT does not offer an additional advantage to comprehensive wound care in reducing the indication for amputation or facilitating wound healing in patients with chronic DFUs.
authors.affiliation: Toronto General Hospital, University Health Network, Toronto, ON, Canada ludwik.fedorko@uhn.ca.
authors.forename: Ludwik
authors.initials: L
authors.lastname: Fedorko
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada Programs for Assessment of Technology in Health, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
authors.forename: James M
authors.initials: JM
authors.lastname: Bowen
authors.affiliation: Toronto General Hospital, University Health Network, Toronto, ON, Canada.
authors.forename: Wilhelmine
authors.initials: W
authors.lastname: Jones
authors.affiliation: Toronto General Hospital, University Health Network, Toronto, ON, Canada.
authors.forename: George
authors.initials: G
authors.lastname: Oreopoulos
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada Programs for Assessment of Technology in Health, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
authors.forename: Ron
authors.initials: R
authors.lastname: Goeree
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada Programs for Assessment of Technology in Health, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Hopkins
authors.affiliation: Department of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada Programs for Assessment of Technology in Health, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
authors.forename: Daria J
authors.initials: DJ
authors.lastname: O'Reilly
mesh_terms: D000368:Aged; D000671:Amputation, Surgical; D002908:Chronic Disease; D017719:Diabetic Foot / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006931:Hyperbaric Oxygenation; D035002:Lower Extremity; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014945:Wound Healing / Q000502:physiology*