Both micro- and macrovascular components probably mutually contribute to the increased mortality in people with diabetic foot ulcers (DFU). We have previously shown that QTc-time is an important risk factor for mortality and that hyperbaric oxygen therapy (HBO) seems to reduce QTc-time prolongation. The aim of this study based on our randomized clinical trial was to evaluate the effect of HBO on 6-year survival in people with hard-to-heal DFU as well as a possible relation to QTs-time on survival.
Methods: People with DFU of ≥3 months duration without any indication or possibility of vascular surgical intervention were randomized to either HBO (2.5 ATA, 90 minutes) or hyperbaric air (Ctrl) treatment. Only those who fulfilled the pre-specified criterion of completing at least 36 out of 40 treatments sessions were included in the evaluation.
Results: No statistical differences in baseline characteristics were seen between groups. The 6-year survival was 58% (22/38) in the HBO, and 35% (13/37) in the Ctrl group (LogRank p<0.048). Survival in those with a baseline QTc-time > 420 ms are given in Figure 1. In a Cox Regression analysis including treatment allocation, presence of coronary heart disease and age, only treatment allocation was a statistically significant factor associated with survival (p=0.038).
M. Londahl: Speaker's Bureau; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company. Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; ReApplix AS. K. Fagher: Speaker's Bureau; Self; AstraZeneca, Sanofi, Novo Nordisk A/S, Merck Sharp & Dohme Corp. A. Nilson: Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. P. Katzman: None.