Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O'Reilly DJ, et al.
Diabetes care. Date of publication 2016 Mar 1;volume 39(3):392-9.
1. Diabetes Care. 2016 Mar;39(3):392-9. doi: 10.2337/dc15-2001. Epub 2016 Jan 6.
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.
Fedorko L(1), Bowen JM(2), Jones W(3), Oreopoulos G(3), Goeree R(2), Hopkins
RB(2), O'Reilly DJ(2).
Author information:
(1)Toronto General Hospital, University Health Network, Toronto, ON, Canada
ludwik.fedorko@uhn.ca.
(2)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.
(3)Toronto General Hospital, University Health Network, Toronto, ON, Canada.
Comment in
Diving Hyperb Med. 2016 Sep;46(3):133-134.
Diabetes Care. 2016 Aug;39(8):e135.
Diabetes Care. 2016 Aug;39(8):e133-4.
Diabetes Care. 2016 Aug;39(8):e131-2.
Diabetes Care. 2016 Aug;39(8):e136-7.
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.
RESEARCH DESIGN AND 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.
© 2016 by the American Diabetes Association. Readers may use this article as long
as the work is properly cited, the use is educational and not for profit, and the
work is not altered.
DOI: 10.2337/dc15-2001
PMID: 26740639 [Indexed for MEDLINE]
