Comment on Fedorko et al. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care 2016;39:392–399

More than 3 years after the last study visit, the study by Fedorko et al. (1) was published in Diabetes Care . Several issues need to be highlighted, some of which are discussed here.If the end point “indication for [major] amputation” is more appropriate than “major amputation” (1), only the future can tell. Amputation rate assumption of 39.39 vs. 11.54% within a 3-month period in an outpatient care setting seems odd. Accordingly, amputation rates in the trial by Faglia et al. including hospitalized patients with severe and acute infected Wagner grade 3/4 ulcers were 9 vs. 33%, and the 1-year major amputation rate in the outpatient care studies by Abidia …