OBJECTIVE Conflicting evidence exists on the effects of hyperbaric oxygen therapy (HBOT) in the treatment of chronic ischemic leg ulcers. The aim of this trial was to investigate whether additional HBOT would benefit patients with diabetes and ischemic leg ulcers. RESEARCH DESIGN AND METHODS Patients with diabetes with an ischemic wound (n = 120) were randomized to standard care (SC) without or with HBOT (SC+HBOT). Primary outcomes were limb salvage and wound healing after 12 months, as well as time to wound healing. Other end points were amputation-free survival (AFS) and mortality. RESULTS Both groups contained 60 patients. Limb salvage was achieved in 47 patients in the SC group vs. 53 patients in the SC+HBOT group (risk difference [RD] 10% [95% CI -4 to 23]). After 12 months, 28 index wounds were healed in the SC group vs. 30 in the SC+HBOT group (RD 3% [95% CI -14 to 21]). AFS was achieved in 41 patients in the SC group and 49 patients in the SC+HBOT group (RD 13% [95% CI -2 to 28]). In the SC+HBOT group, 21 patients (35%) were unable to complete the HBOT protocol as planned. Those who did had significantly fewer major amputations and higher AFS (RD for AFS 26% [95% CI 10-38]). CONCLUSIONS Additional HBOT did not significantly improve complete wound healing or limb salvage in patients with diabetes and lower-limb ischemia.

中文翻译：

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高压氧疗法治疗糖尿病患者的缺血性下肢溃疡：DAMO2CLES多中心随机临床试验的结果。

目的高压氧疗法（HBOT）在治疗慢性缺血性腿部溃疡中的作用存在矛盾的证据。该试验的目的是调查是否额外的HBOT药物可以使糖尿病和缺血性腿部溃疡患者受益。研究设计和方法将患有缺血性伤口（n = 120）的糖尿病患者随机分配到没有或没有HBOT的标准护理（SC）（SC + HBOT）。主要结果是12个月后肢体抢救和伤口愈合以及伤口愈合时间。其他终点是无截肢生存率和死亡率。结果两组均包含60例患者。SC组47例患者实现了肢体抢救，而SC + HBOT组53例患者实现了肢体抢救（风险差异[RD] 10％[95％CI -4至23]）。12个月后，SC组与对照组相比，治愈了28个指数伤口。SC + HBOT组为30（RD 3％[95％CI -14至21]）。SC组41例患者和SC + HBOT组49例患者获得了AFS（RD 13％[95％CI -2至28]）。在SC + HBOT组中，有21名患者（35％）无法按计划完成HBOT方案。那些患者的截肢量明显减少，而AFS较高（AFS的RD为26％[95％CI 10-38]）。结论额外的HBOT不能显着改善糖尿病和下肢缺血患者的完全伤口愈合或肢体抢救。