Hyperbaric oxygen therapy (i.e., breathing 100% oxygen under high atmospheric pressure) has shown mixed results in studies of diabetic foot ulcers. Now, in a multicentre U.S. and European trial, investigators examined whether topical oxygen promotes healing of such ulcers.
Seventy-three patients with diabetic foot ulcers were randomised to receive pressurised oxygen topically (administered through a chamber placed over the extremity) or sham treatment (same device, delivering non-pressurised room air). Enrollment criteria included ulcer size of 1 to 20 cm2, at least 1 month of unsuccessful treatment, and absence of severe limb ischaemia. Patients treated themselves at home, 5 times weekly, for 90 minutes per session. At 12 weeks, complete ulcer healing occurred in 42% of intervention patients and in 14% of sham-control patients (P=0.01). At 1 year, rates of complete healing remained greater in the intervention group (56% vs. 27%; P=0.01).
The results of this trial (which was funded by the maker of the device) are quite impressive, but a non–industry-supported trial to corroborate the findings would be welcome. The device used in the trial is available commercially, but the cost of a course of treatment is unclear.