(CR-028) Successful Treatment of Moderately Ischemic Dfu's Using Intermittent Topical Oxygen (TWO2)

Dane Wukich, MD

Introduction: This study evaluated intermittent topical oxygen therapy )TWO2) in the treatment of moderately ischemic DFU's.

Methods: Patients included in this study were part of a post hoc analysis of a randomized prospective double-blind study that evaluated TWO2 in treating DFU. Inclusion criteria were as follows: diabetic patients with nonhealing, full-thickness DFUs measuring between 1cm2 < UT grade 1 or 2 DFU < 20 cm2 post debridement. The duration of the DFU was between 4 weeks and 1 year and all had received standard care for at least 4 weeks.

Patients received the same foam dressings, a below knee offloading device, equivalent to TCC and optimal standard care. Patients who then failed a 2-week run-in period received either a TWO2 or sham device, both devices looked and operated identically.

Moderate ischemia, according to IWGDF criteria, as defined as anyone or combination of the following ABI ≥ 0.7, TBI < 0.75, monophasic biphasic Doppler waves below the knee, TCPO2 < 60, great toe pressure < 60 or skin perfusion pressure < 60.

Results: 18 patients each were included in the study group and sham group. At 12 weeks, 7 of 18 patients (39%) in the TWO2 healed completely compared to 0 of 18 patients (0%) in the sham group (p < 0.0076).

Discussion: This randomized study demonstrated that moderately ischemic diabetic foot ulcers had significantly higher healing rates using TWO2 than the sham treatment. TWO2 provides a multimodal approach to achieve higher healing rates by increasing oxygenation, providing non-contact compression and humidification.This randomized study demonstrated that moderately ischemic diabetic foot ulcers had significantly higher healing rates using TWO2 than the sham treatment. TWO2 provides a multimodal approach to achieve higher healing rates by increasing oxygenation, providing non-contact compression and humidification.