Post-surgical diabetic foot ulcers remain challenging to manage when negative pressure wound therapy cannot be easily applied in the toe regions. A prospective controlled comparative pilot study published in Diabetology evaluated the effectiveness of an oxygen-enriched oil-based device in patients with post-surgical diabetic foot ulcers.
The study enrolled 40 patients with diabetes mellitus and post-surgical foot wounds, including narrow and deep lesions and tunneling ulcers, treated at the Diabetic Foot Unit of San Donato Hospital in Arezzo between March 2024 and April 2025. Participants were allocated to standard wound care (n = 20) or treatment with the oxygen-enriched oil-based device (n = 20). The primary outcome was complete wound healing at 16 weeks. Exploratory endpoints included wound area reduction at 4 and 16 weeks, onset of infection, need for re-intervention, and adverse events.
Complete wound healing at 16 weeks occurred in 85.0% of patients treated with the device and 45.0% receiving standard care (p = 0.020). Wound area reduction at 16 weeks was greater with the device than with standard therapy (89.8% vs 64.0%, p = 0.013).
Infection occurred in 10.0% of patients treated with the device and 35.0% receiving standard care (p = 0.130). Re-intervention was required in 0% of the device group and 25.0% of the control group (p = 0.056). No adverse events were reported. The findings indicate higher healing rates with the oxygen-enriched oil-based device in post-surgical diabetic foot ulcers. Larger randomized controlled trials are warranted to confirm these results and assess long-term outcomes.