Treatment of Nonhealing Diabetic Foot Wounds with Vaporous Hyperoxia Therapy in Conjunction with Standard Wound Care.

Abstract

Vaporous hyperoxia therapy (VHT), a patented US Food and Drug Administration 510 (k)-cleared technology, is an adjunct therapy used in conjunction with standard wound care (SWC). Vaporous hyperoxia therapy is said to improve the health of wounded tissue by administering a low-frequency, noncontact, nonthermal, ionic, antimicrobial hydrating mist alternating with concentrated topical oxygen therapy. Vaporous hyperoxia therapy was used to treat 36 subjects with chronic diabetic foot ulcers (DFUs) that were previously treated unsuccessfully with SWC. The average age of DFUs in the study was 11 months and the average size was over 3 cm2. Wounds were Wagner grade 2 or 3 and most commonly on the plantar surface around the midfoot. Treatment consisted of twice-weekly applications of VHT and wound debridement. Subjects were followed to wound closure, 20 weeks, or 40 treatments, whichever came first. The combination of SWC and VHT in the group that met and maintained compliance throughout the study period achieved an 83% DFU closure rate within a 20-week period. The average time for DFU closure in this study was 9.4 weeks. Historical analysis of SWC shows a 30.9% healing rate of all wounds, not differentiating chronic wounds. Accordingly, SWC/VHT increases chronic diabetic foot ulcer healing rates by 2.85 times compared with SWC alone. The purpose of this study was two-fold: first, to observe the effect of VHT on healing rates and time to healing in previously nonhealing DFUs; and second, to compare VHT with SWC, topical oxygen therapy, hyperbaric oxygen therapy, and ultrasound therapy.