Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Copenhagen, Rigshospitalet, Denmark
Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Copenhagen, Rigshospitalet, Denmark.
BMJ Open. 2020 Jun 29;10(6):e031708. doi: 10.1136/bmjopen-2019-031708.
Diabetic foot ulcer represents a major health problem globally. Preliminary studies have indicated that systemic treatment of diabetic foot ulcer patients with hyperbaric oxygen therapy have beneficial effects on wound healing, risk of amputation, glycaemic control, atherosclerosis, inflammatory markers and other clinical and laboratory parameters. This protocol for a systematic review aims at identifying the beneficial and harmful effects of adding hyperbaric oxygen therapy to standard wound care for diabetic foot ulcers.
This protocol was performed following the recommendations of the Cochrane Collaboration and the eight-step assessment procedure suggested by Jakobsen and colleagues. We plan to include all relevant randomised clinical trials assessing the effects of hyperbaric oxygen therapy in the treatment of diabetic foot ulcer versus any control group with any intervention defined as standard wound care or similar, together with sham interventions. Our primary outcome will be: all-cause mortality, serious adverse events and quality of life. Our secondary outcomes will be: healing of index wound, major amputation and wound infection. Any eligible trial will be assessed and classified as either high risk of bias or low risk of bias, and our conclusions will be based on trials with low risk of bias. The analyses of the extracted data will be performed using Review Manager 5 and Trial Sequential Analysis. For both our primary and secondary outcomes, we will create a 'Summary of Findings' table and use GRADE (Grading of Recommendations Assessment, Development and Evaluation) assessment to assess the quality of the evidence.
We use publicly accessible documents as evidence, there is no participant involvement at an individual level and an institutional ethics approval is not required. The results of the review will be sought published in a peer-reviewed journals, also in the event of insignificant results or null results, and thereby it will be disseminated to clinicians and public available.
CRD42019139256.
糖尿病足溃疡是一个全球性的主要健康问题。初步研究表明，高压氧疗法对糖尿病足溃疡患者进行全身性治疗对伤口愈合、截肢风险、血糖控制、动脉粥样硬化、炎症标志物和其他临床及实验室参数有有益影响。本系统评价方案旨在确定在糖尿病足溃疡的标准伤口护理基础上加用高压氧疗法的有益和有害效果。
本方案按照 Cochrane 协作组的建议和 Jakobsen 及其同事提出的八步评估程序进行。我们计划纳入所有评估高压氧疗法治疗糖尿病足溃疡与任何对照组（任何定义为标准伤口护理或类似的干预措施）效果的相关随机临床试验，以及假干预。我们的主要结局将是：全因死亡率、严重不良事件和生活质量。我们的次要结局将是：指数伤口愈合、主要截肢和伤口感染。任何符合条件的试验都将进行评估和分类，分为高偏倚风险或低偏倚风险，我们的结论将基于低偏倚风险的试验。提取数据的分析将使用 Review Manager 5 和试验序贯分析进行。对于我们的主要和次要结局，我们将创建一个“结局总结”表，并使用 GRADE（推荐评估、制定与评价）评估来评估证据的质量。
我们使用公开获取的文件作为证据，没有个体层面的参与者参与，也不需要机构伦理批准。综述的结果将在同行评议的期刊上发表，即使结果不显著或为零结果，也将向临床医生和公众传播。
PROSPERO 注册号：CRD42019139256。
