Comment on Löndahl. Number Eight in the Service of Diabetic Foot Ulcer Healing. Diabetes Care 2020;43:515–517

We appreciate the thoughtful commentary by Londahl (1) on our recent article (2) describing the positive results of our double-blinded, randomized, placebo-controlled trial of the effect of cyclical, pressurized Topical Wound Oxygen (TWO2) therapy for healing chronic diabetic foot ulcers (DFUs). Recognizing that no study can be considered perfect in design, execution, or outcomes, we welcome this opportunity to address the concerns raised by Dr. Londahl pertaining to the aforementioned randomized controlled trial (RCT) (2). First, we do agree that the results of recent hyperbaric oxygen therapy (HBOT) trials are inconsistent and generally fail to provide robust evidence to support the adjunctive use of HBOT for DFUs (3–5). Much of the failure to provide consistent results is due to study design deficiencies; heterogeneity in study populations, inclusion criteria, and outcome measures (DFU healing vs. amputation); lack of sham controls; and loss of subjects because of adverse events and early terminations (6,7). Furthermore, intention-to-treat (ITT) analyses of all enrolled study populations has not been uniformly reported (3). Another difficulty in this regard …