Commentary on A multinational, multicenter, randomized, double-blinded, placebo-controlled trial to evaluate the efficacy of cyclical topical wound oxygen therapy (TWO2) in the treatment of chronic diabetic foot ulcers: The TWO2 study

Topical Oxygen therapy (TOT) in various forms has been used for the treatment of chronic wounds for over fifty years [1-6 ]. Its effectiveness has been disputed despite many positive clinical and animal reports attesting to its benefits towards promoting wound healing. Various delivery mechanisms have been utilized in this regard including continuous delivery of oxygen (CDO) under low or very low Oxygen tensions or Cyclical Pressurized topical delivery generally within a localized extremity chamber. Hyperbaric Oxygen Therapy (HBOT) proponents have long criticized the ability of TOT to have a meaningful effect on wound repair in the absence of systemic delivery of Oxygen [7]. Despite the many inconsistent wound healing clinical studies of HBOT itself [8-13], most criticisms of TOT, notwithstanding the skepticism mentioned above, are due to an extremely limited number of robust high-quality investigations. We therefore performed a study to assess the efficacy of multi-modality cyclical pressure Topical Wound Oxygen (TWO2) homecare therapy in healing refractory diabetic foot ulcers (DFU) that had failed to heal with standard of care (SOC) alone [14].