Topical, at-home oxygen therapy aids diabetic foot ulcer healing
medwireNews: Home use of cyclical pressurized topical wound oxygen therapy (TWO2) in addition to standard care increases the likelihood of diabetic foot ulcers completely healing more than fourfold, a sham-controlled trial indicates.
The TWO2 double-blind, randomized study involving 73 patients with diabetes receiving the standard of care showed that 41.7% of those treating themselves with a TWO2 device for 90 minutes a day, 5 days per week, experienced the primary endpoint of complete healing of their refractory diabetic foot ulcers within 12 weeks.
By contrast, 13.5% of those using sham treatment achieved complete healing, giving an odds ratio of 4.57 in favor of TWO2 therapy.
This benefit remained significant, at a hazard ratio of 4.66, in Cox proportional hazards modeling accounting for factors including ulcer grade according to the University of Texas Classification (UTC) system.
More than twice as many of the ulcers treated with TWO2 home care had closed at 12 months compared with those given sham treatment, a significant difference in this secondary endpoint (56 vs 27%, respectively).
There were also statistically significant improvements with active versus sham treatment in the secondary endpoints of wound area reduction at 12 weeks, change in ulcer area for patients with larger open ulcers, and in patient wellbeing.
The international study included patients from 17 diabetic foot centers, 89% with type 2 diabetes and 11% with type 1 diabetes, who all had nonhealing, full-thickness UTC grade 1 or 2 diabetic foot ulcers measuring 1 to 20 cm after debridement.
Active treatment used a TWO2 therapy device cleared by the US FDA, which operates by inflation of a single-use extremity chamber over the patient’s limb, after which humidified oxygen is cycled between 10 mb and 50 mb within the chamber.
The sham device looked identical but did not deliver pressurized oxygen. Dressings were changed at home by either the patient or their personal caregiver. Participants visited a local study center weekly for wound assessment, debridement, and digital wound photographs.
The number of adverse events during the study was identical in both treatment arms, with none relating to the TWO2 device.
“This therapy was safe, without complications, and provided more durable healing for those who had wound closure during active treatment,” report Robert Frykberg (Midwestern University, Glendale, Arizona, USA) and colleagues in Diabetes Care.
“Uniquely, the therapy has additional benefit in that it can be administered by the patient at home without the expense and difficulties of daily travel to a specialized center.”
Studies using a hyperbaric oxygen chamber have produced negative results, but participants found daily trips to a specialized center to be burdensome, and a recent study showed significant benefit limited to those who actually completed the treatment.
By Anita Chakraverty
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