Table 2

Summary of the results for indication for amputation

HBOTShamOR (95% CI)P value
Adjudicated indication for amputation (ITT)
 n4954
 Major11 (22.5)13 (24.1)0.91 (0.37, 2.28)0.846
 Minor14 (28.6)13 (24.1)1.26 (0.52, 3.04)0.605
 Total25 (51.0)26 (48.1)1.12 (0.52, 2.43)0.771
Adjudicated indication for amputation (per protocol)*
 n3948
 Major8 (20.5)11 (22.9)0.87 (0.31, 2.43)0.787
 Minor9 (23.1)9 (18.8)1. 30 (0.46, 3.68)0.621
 Total17 (43.6)20 (41.7)1.08 (0.46, 2.54)0.857
  • Data are n (%) unless otherwise indicated. HBOT is reference.

  • *At least 27 HBOT treatments or healed without discontinuation or withdrawal.