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Question clinique
Is topical oxygen effective in hastening the healing of refractory diabetic foot ulcers?
L’Essentiel
Hyperbaric oxygen provided with a device that cycles oxygen from high pressure to low pressure increased the likelihood of complete healing of diabetic foot ulcers (DFUs) when combined with standard dressing and an offloading boot. This study was a small one, though, and fewer than half (41.7%) of the patients responded after 3 months of treatment 1b-
Référence
Plan de l'etude: Randomized controlled trial (double-blinded)
Financement: Industry
Cadre: Outpatient (specialty)
Sommaire
These investigators enrolled 73 patients with diabetes who had been recruited from wound centers. The patients had full-thickness DFUs between 1 cm2 and 19 cm2 and had been treated for at least 4 weeks. They were observed for an additional 2 weeks, treated with dressing and a rocker sole boot, and were enrolled into the study if they failed to have at least a 30% decrease in wound area with this treatment. Using concealed allocation, the study patients were treated with a closed chamber device that provided hyperbaric oxygen cycled between 10 mb and 50 mb (Hyperbox) or a sham device that circulated nonpressurized ambient air. Patients used the device 90 minutes each day 5 times a week. Using intention-to-treat analysis, after 12 weeks of treatment, 41.7% of patients who received oxygen had complete wound healing as compared with 13.5% who received sham treatment (P = .01). For patients without total healing, oxygen therapy was discontinued and usual care was continued for up to 1 year. By 12 months (9 months after discontinuing hyperbaric oxygen), 56% of patients who received oxygen had complete healing as compared with 27% of patients who received sham treatment. Adverse events were reported in both groups; none were related to the device.
Reviewer
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA
Commentaires
Diabetic foot ulcer
Slow healing of diabetic foot ulcer