Original Economic analysis of hyperbaric oxygen therapy for the treatment of ischaemic diabetic foot ulcers

Introduction: The aim was to determine the cost-effectiveness and cost-utility of additional hyperbaric oxygen therapy (HBOT) compared to standard care (SC) for ischaemic diabetic foot ulcers (DFUs) regarding limb salvage and health status. Methods: An economic analysis was conducted, comprising cost-effectiveness and cost-utility analyses, with a 12-month time horizon, using data from the DAMO2CLES multicentre randomised clinical trial. Cost-effectiveness was defined as cost per limb saved and cost-utility as cost per quality-adjusted life year (QALY). The difference in cost effectiveness between HBOT+SC and SC alone was determined via an incremental cost-effectiveness ratio (ICER). Results: One-hundred and twenty patients were included, with 60 allocated to HBOT+SC and 60 to SC. No significant cost difference was found in the intention-to-treat analysis: <euro>3,791 (bias corrected and accelerated [BCA] 95% CI, <euro>3,556 - <euro>-11,138). Cost per limb saved showed an ICER of <euro>37,912 (BCA 95% CI <euro>-112,188-<euro>1,063,561) for HBOT+SC vs. SC. There was no significant difference in mean QALYs: 0.54 for HBOT+SC vs. 0.56 for SC alone (-0.02; BCA 95% CI-0.11-0.08). This resulted in a cost-utility of minus <euro>227,035 (BCA 95% CI <euro>-361,569,550-<euro>-52,588) per QALY. Subgroup analysis for Wagner stages III/IV showed an ICER of <euro>19,005 (BCA 95%CI, <euro>-18,487-<euro>264,334) while HBOT did not show any benefit for Wagner stage II. Conclusions: HBOT as an adjunct to SC showed no significant differences in costs and effectiveness for patients with DFUs regarding limb salvage and health status. However, for patients with Wagner stage III/IV ischaemic DFUs there was a trend towards better effectiveness and cost-effectiveness.