Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands.
J Diabetes. 2015 Jan;7(1):125-32. doi: 10.1111/1753-0407.12155. Epub 2014 Apr 28.
The value of hyperbaric oxygen therapy (HBOT) in the treatment of diabetic ulcers is still under debate. Available evidence suggests that HBOT may improve the healing of diabetic ulcers, but it comes from small trials with heterogeneous populations and interventions. The DAMOCLES-trial will assess the (cost-)effectiveness of HBOT for ischemic diabetic ulcers in addition to standard of care.
In a multicenter randomized clinical trial, including 30 hospitals and all 10 HBOT centers in the Netherlands, we plan to enroll 275 patients with Types 1 or 2 diabetes, a Wagner 2, 3 or 4 ulcer of the leg present for at least 4 weeks, and concomitant leg ischemia, defined as an ankle systolic blood pressure of <70 mmHg, a toe systolic blood pressure of <50 mmHg or a forefoot transcutaneous oxygen tension (TcpO2) of <40 mmHg. Eligible patients may be candidates for revascularization. Patients will be randomly assigned to standard care with or without 40 HBOT-sessions.
Primary outcome measures are freedom from major amputation after 12 months and achievement of, and time to, complete wound healing. Secondary endpoints include freedom from minor amputations, ulcer recurrence, TcpO2 , quality of life, and safety. In addition, we will assess the cost-effectiveness of HBOT for this indication.
The DAMOCLES trial will be the largest trial ever performed in the realm of HBOT for chronic ulcers, and it is unique for addressing patients with ischemic diabetic foot ulcers who may also receive vascular reconstructions. This matches the treatment dilemma in current clinical practice.
高压氧治疗（HBOT）在治疗糖尿病溃疡中的价值仍存在争议。现有证据表明，HBOT 可能改善糖尿病溃疡的愈合，但这些证据来自于人群和干预措施存在异质性的小型试验。DAMOCLES 试验将评估 HBOT 治疗缺血性糖尿病溃疡的（成本）效益，除了标准治疗。
在一项多中心随机临床试验中，我们计划纳入 30 家医院和荷兰所有 10 家 HBOT 中心的 275 名 1 型或 2 型糖尿病患者，这些患者腿部有 Wagner 2、3 或 4 期溃疡，且存在至少 4 周的伴发性腿部缺血，定义为踝部收缩压<70mmHg、趾部收缩压<50mmHg 或足底前区经皮氧分压（TcpO2）<40mmHg。符合条件的患者可能是血管重建的候选者。患者将被随机分配接受标准治疗加或不加 40 次 HBOT 治疗。
主要终点是 12 个月后免于大截肢和完全愈合的实现和时间。次要终点包括免于小截肢、溃疡复发、TcpO2、生活质量和安全性。此外，我们将评估 HBOT 对此适应证的成本效益。
DAMOCLES 试验将是 HBOT 治疗慢性溃疡的最大试验，它是独一无二的，因为它针对的是可能还接受血管重建的缺血性糖尿病足溃疡患者。这符合当前临床实践中的治疗困境。
