The addition of hyperbaric oxygen therapy to standard care did not substantially improve outcomes in adults with diabetes with an ischemic wound compared with standard care treatment alone, according to findings published in Diabetes Care.
Dirk T. Ubbink, MD, PhD, of the department of surgery at Academic Medical Center in Amsterdam, and colleagues evaluated data from the DAMO2CLES trial on 120 adults with diabetes and an ischemic wound randomly assigned to standard care with (n = 60) or without hyperbaric oxygen therapy (n = 60) to determine whether hyperbaric oxygen therapy is beneficial for ischemic wound treatment. Participants were recruited between June 2013 and December 2015. The primary outcomes included limb salvage and wound healing after 12 months. Follow-up visits occurred at 3, 6 and 12 months after recruitment.
Major amputation of the index limb was required in 22% of the standard care-only group compared with 12% of the combination group, for a risk difference of limb salvage of 10% during follow-up.
Wounds healed in more participants in the combination group than in the standard care-only group during the study (55% vs. 48%) and at the end of follow-up (50% vs. 47%). More participants in the combination group remained free of any amputation (63% vs. 52%) and were alive and free from major amputation on the index limb (82% vs. 68%) at the end of follow-up. Fewer participants in the combination group than in the standard care-only group underwent planned revascularization that was not planned at the study inclusion (23% vs. 28%). Nearly one-third of participants in each group developed a new ulcer during follow-up.
Fewer participants in the combination group died compared with the standard care-only group (8% vs. 15%).
According to the researchers, addition of hyperbaric oxygen therapy to standard care did not significantly benefit limb salvage or wound healing.
“An important observation from the DAMO2CLES trial is that a substantial proportion of the patients who were eligible for participants may not be able to undergo a complete [hyperbaric oxygen therapy] regimen due to their unfavorable overall medical condition,” the researchers wrote. – by Amber Cox
Disclosures: The authors report no relevant financial disclosures.