A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol
A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol
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DOI：
10.1186/1745-6215-12-69
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发表时间：
2011-03-07
期刊：
影响因子：
2.5
通讯作者：
Goeree, Ron
中科院分区：
文献类型：
--
作者：
O'Reilly, Daria;Linden, Ron;Goeree, Ron
背景：已有研究表明，使用辅助高压氧治疗可以改善糖尿病足溃疡的愈合，并降低下肢截肢的风险。有限数量的研究使用双盲方法来评估高压氧治疗糖尿病溃疡的疗效。本研究的主要目的是评估高压氧治疗加标准伤口护理与单独标准伤口护理在预防糖尿病和下肢慢性溃疡患者大截肢的疗效。方法/设计：在Judy Dan研究和治疗中心招募118例（每臂59例）下肢未愈合的糖尿病溃疡患者，如果他们年满18岁，患有1型或2型糖尿病，且下肢足部病变瓦格纳分级为2、3或4，至少4周未愈合。患者在治疗阶段每天接受高压氧治疗，持续6周，并提供持续的伤口护理和每周评估。患者被要求每周返回研究中心进行额外6周的伤口评估和处理随访。主要结局是在随机分组后12周内没有或符合主要截肢（膝盖以下截肢或跖骨截肢）的标准。截肢是由血管外科医生决定的。其他结果包括伤口愈合、有效性、安全性、医疗资源利用、生活质量和成本效益。这项研究将持续约3年。讨论：本研究的结果将提供高压氧治疗下肢不愈合溃疡疗效的详细信息。这将是该健康技术的首个双盲随机对照试验，该试验评估高压氧治疗在预防糖尿病患者截肢方面的疗效。
Background: It has been suggested that the use of adjunctive hyperbaric oxygen therapy improves the healing of diabetic foot ulcers, and decreases the risk of lower extremity amputations. A limited number of studies have used a double blind approach to evaluate the efficacy of hyperbaric oxygen therapy in the treatment of diabetic ulcers. The primary aim of this study is to assess the efficacy of hyperbaric oxygen therapy plus standard wound care compared with standard wound care alone in preventing the need for major amputation in patients with diabetes mellitus and chronic ulcers of the lower limb.Methods/Design: One hundred and eighteen (59 patients per arm) patients with non-healing diabetic ulcers of the lower limb, referred to the Judy Dan Research and Treatment Centre are being recruited if they are at least 18 years of age, have either Type 1 or 2 diabetes with a Wagner grading of foot lesions 2, 3 or 4 on lower limb not healing for at least 4 weeks. Patients receive hyperbaric oxygen therapy every day for 6 weeks during the treatment phase and are provided ongoing wound care and weekly assessments. Patients are required to return to the study centre every week for an additional 6 weeks of follow-up for wound evaluation and management. The primary outcome is freedom from having, or meeting the criteria for, a major amputation (below knee amputation, or metatarsal level) up to 12 weeks after randomization. The decision to amputate is made by a vascular surgeon. Other outcomes include wound healing, effectiveness, safety, healthcare resource utilization, quality of life, and cost-effectiveness. The study will run for a total of about 3 years.Discussion: The results of this study will provide detailed information on the efficacy of hyperbaric oxygen therapy for the treatment of non-healing ulcers of the lower limb. This will be the first double-blind randomized controlled trial for this health technology which evaluates the efficacy of hyperbaric oxygen therapy in prevention of amputations in diabetic patients.