Adults with diabetes and chronic lower limb wounds randomly assigned to 6 weeks of hyperbaric oxygen therapy or a sham procedure met similar amputation criteria and experienced similar wound healing rates at the conclusion of treatment, according to research in Diabetes Care.
In a prospective, double blind, randomized controlled trial, Ludwik Fedorko, MD, PhD, FRCPC, of Toronto General Hospital and University Health Network in Ontario, Canada, and colleagues analyzed data from 107 adults with type 1 or type 2 diabetes and chronic lower limb wounds persisting for a minimum of 4 weeks. Within the cohort, 49 participants were randomly assigned to 30 daily sessions of hyperbaric oxygen therapy lasting 90 minutes each (breathing oxygen at 244 kPa); 54 participants were assigned to a sham procedure (breathing oxygen at 125 kPa; equivalent to breathing 27% oxygen by face mask), in addition to receiving comprehensive wound care. Researchers followed patients for 6 weeks after hyperbaric sessions ended; patients returned to the clinic weekly for wound assessment and treatment. Data to evaluate wound healing were collected at baseline and weekly throughout treatment and follow-up. A masked vascular surgeon determined whether amputation (major or minor) was indicated at the end of the study period. The primary outcome was freedom from meeting the requirements for amputation at 12 weeks after the study; secondary outcomes were wound healing measurements.
Researchers found that 11 patients in the hyperbaric oxygen group met criteria for amputation after 6 weeks of therapy vs. 13 patients in the sham group (OR = 0.91; 95% CI, 0.37-2.28). Ten patients in the hyperbaric oxygen group experienced wound healing vs. 12 patients in the sham group (OR = 0.9; 95% CI, 0.35-2.31).
The researchers noted that, despite randomization, patients in the hyperbaric oxygen group had a longer diabetes duration than the sham group (mean of 19.1 years vs. 12.4 years), and the sham group had more men (38 vs. 31). The mean number of days with the index wound was higher in the sham group (336 days vs. 235 days).
“The adjuvant [hyperbaric oxygen therapy] care provided no incremental benefit in improving measures of wound healing,” the researchers wrote. “These results are in contrast to several cohort and open-label randomized trials where no sham placebo was used.” – by Regina Schaffer
The researchers report no relevant financial disclosures.