Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients with Diabetes with Non-Healing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

摘要

To determine the efficacy of hyperbaric oxygen therapy (HBOT) in reducing indications for amputation and to ascertain if HBOT leads to the improvement of selected wound healing indicators in diabetic patients with chronic ulcers of the lower limb. Diabetic patients with chronic lower-limb wounds were randomly assigned to receive either HBOT or sham HBOT in addition to comprehensive wound care, in a single-center, double-blind, placebo-controlled randomized clinical trial. Patients over 18 with type 1 or 2 diabetes were referred for hyperbaric treatment of a wound (Wagner grade 2, 3 or 4) persisting for a minimum of four weeks. Anticipating a 20% drop-out rate, a sample size of 118 patients (59 in each group) was calculated to provide 90% power for detecting a difference of 28% in the incidence of major amputation between the two groups. A computerized block randomization schedule with a multiple block size of four was used for randomization and allocation concealment.