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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: €3,791 (bias corrected and accelerated [BCA] 95% CI, €3,556 - €-11,138). Cost per limb saved showed an ICER of €37,912 (BCA 95% CI €-112,188 - €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 €227,035 (BCA 95% CI €-361,569,550 - €-52,588) per QALY. Subgroup analysis for Wagner stages III/IV showed an ICER of €19,005 (BCA 95%CI, -€18,487 - €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., Competing Interests: No conflicts of interest were declared., (Copyright: This article is the copyright of the authors who grant Diving and Hyperbaric Medicine a non-exclusive licence to publish the article in electronic and other forms.)

Diabetic foot ulcers are a common complication of diabetes, which affects 25% of patients and may ultimately lead to amputation of affected limbs. Research suggests hyperbaric oxygen therapy improves healing of these ulcers. However, this has not been reflected in previous reviews, possibly because they did not differentiate between patients with and without peripheral arterial occlusive disease. Therefore, we performed a systematic review of published literature in the MEDLINE, Embase, and Cochrane CENTRAL databases on nonischemic diabetic foot ulcers with outcome measures including complete ulcer healing, amputation rate (major and minor), and mortality. Seven studies were included, of which two were randomized clinical trials. Two studies found no difference in major amputation rate, whereas one large retrospective study found 2% more major amputations in the hyperbaric oxygen group. However, this study did not correct for baseline differences. Two studies showed no significant difference in minor amputation rate. Five studies reporting on complete wound healing showed no significant differences. In conclusion, the current evidence suggests that hyperbaric oxygen therapy does not accelerate wound healing and does not prevent major or minor amputations in patients with a diabetic foot ulcer without peripheral arterial occlusive disease. Based on the available evidence, routine clinical use of this therapy cannot be recommended. However, the available research for this specific subgroup of patients is scarce, and physicians should counsel patients on expected risks and benefits. Additional research, focusing especially on patient selection criteria, is needed to better identify patients that might profit from this therapy modality., (© 2019 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of by the Wound Healing Society.)

Background: Diabetic foot ulcers (DFUs) are frequently associated with peripheral arterial occlusive disease (PAOD) and may ultimately lead to amputations of the lower extremity. Adjuvant hyperbaric oxygen treatment (HBOT) might foster better wound healing and lower amputation rates in patients with DFU and PAOD. A systematic review was conducted to assess the effects of HBOT as an adjunctive therapy to standard treatment for patients with DFUs with PAOD., Methods: Systematic review using the MEDLINE, EMBASE, and Cochrane CENTRAL databases (from inception to October 2018). All original, comparative studies on the effect of HBOT on DFUs with PAOD were eligible. The primary outcome measures were amputation rate, amputation-free survival, complete ulcer healing, and mortality., Results: Eleven studies, totaling 729 patients, were included for analysis, including 7 randomized clinical trials, 2 controlled clinical trials, and 2 retrospective cohorts. Four were used for quantitative synthesis. Meta-analysis showed a significantly fewer major amputations in the HBOT group (10.7% vs 26.0%; risk difference, -15%; 95% confidence interval [CI], -25 to -6; P = .002; number needed to treat, 7; 95% CI, 4-20). No difference was found for minor amputations (risk difference, 8%; 95% CI, -13 to 30; P = .46). Three studies reporting on complete wound healing showed contrasting results. No significant difference was found for mortality or amputation-free survival., Conclusions: Current evidence shows that adjuvant HBOT improves major amputation rate, but not wound healing, in patients with DFUs and PAOD. Given the wide range of patients included in the trials, better patient selection may help define which patients with DFUs and PAOD benefit most from HBOT as standard adjunctive treatment., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)