Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Major Amputations
研究概览
简要总结
The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral vascular disease. The main question is:
- What is the difference is the major amputation rate between the study arms?
Participants will be randomized to 20, 30 or 40 sessions of HBOT or a control group.
详细描述
Objective
The primary objective is to assess the (cost-) effectiveness of HBOT in addition to standard wound care and vascular surgical treatment for patients with a DFU and leg ischaemia.
Study design: An international, multi-arm multi-stage (MAMS) design is chosen to conduct an efficient randomised clinical trial. At a planned interim analysis the best performing study arm(s) will be chosen to continue.
Study population: We need up to 544 patients with a Meggitt-Wagner stage 3 or 4 DFU and proven peripheral ischaemia.
Intervention: Patients will be randomised to receive standard care (wound treatment and surgical interventions following international guidelines) with either 0, 20, 30 or at least 40 sessions of HBOT. These sessions will compromise 90-120 minutes of HBOT at a pressure of 2.2-2.5 ATA according to international standards.
Main study parameters/endpoints: The primary endpoint is major amputation rate after 12 months. Secondary objectives are amputation-free survival, wound healing, health-related quality of life and cost-effectiveness of the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type I or II diabetes
- •One or more deep and clinically infected lower extremity ulcers, classified as Meggitt-Wagner class 3 or 4, Texas class 2C, 3C, 2D or 3D, or WIfI class W>1, I>1 and fI>0), present for at least 4 weeks or after a minor amputation because of a previously existing ischaemic DFU on a toe or forefoot. In case more than one ulcer is present, the largest will be observed as target ulcer
- •Leg ischaemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg
- •Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intraarterial digital subtraction angiography of the ipsilateral leg
- •Patients have to be discussed in, and included after a multidisciplinary consultation.
- •Written informed consent
排除标准
- •Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
- •Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing
- •End-stage renal disease requiring dialysis
- •Metastasized malignancy
- •Left ventricular failure with ejection fraction (EF) <20% or external pacemaker
- •Recent thoracic surgery or middle ear surgery
- •Severe epilepsy
- •Uncontrollable high fever
- •Insufficient proficiency of local language/English, or inability to complete the questionnaires
研究组 & 干预措施
HBOT 20
Patients receiving 20 sessions of concurrent Hyperbaric oxygen treatment
干预措施: Hyperbaric oxygen (Drug)
HBOT 30
Patients receiving 30 sessions of concurrent Hyperbaric oxygen treatment
干预措施: Hyperbaric oxygen (Drug)
HBOT 40
Patients receiving at least 40 sessions of concurrent Hyperbaric oxygen treatment
干预措施: Hyperbaric oxygen (Drug)
结局指标
主要结局
Major Amputations
时间窗: 12 months after inclusion
Major amputations, defined as below the knee or above the knee amputations
次要结局
- Health-related quality of life(Complete follow-up (up to 3 years))
- Cost-effectiveness and budget impact(Complete follow-up (up to 3 years))
- Patients perception of improvement(Complete follow-up (up to 3 years))
- Complete wound healing(12 months after inclusion)
- Pain scores(12 months after inclusion)
- Need for additional (vascular) interventions(Complete follow-up (up to 3 years))
- Amputation-free survival(Complete follow-up (up to 3 years))
- Mortality(Complete follow-up (up to 3 years))
- TcpO2 before, during and after HBOT(During intervention period)
研究者
Dirk T. Ubbink
Professor Doctor
Amsterdam UMC, location AMC