Microwave Radiometry Thermometry for Non-invasive Diagnosis of Arterial Disease in Diabetic Patients With Suspected Critical Limb Ischemia: A Multi-centre Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Mean foot tissue temperature
研究概览
简要总结
Diagnosis of vascular involvement in diabetic foot disease remains challenging. Differential diagnosis between pure neuropathic or neuro-ischemic diabetic foot requires a combination of clinical examination, medical history and ankle-brachial index (ABI) measurement, which is considered the "gold standard" non-invasive modality for limb ischemia diagnosis. However, in diabetic patients with suspected arterial ischemia resulting in tissue loss (critical limb ischemia; CLI), false negative ABI results are frequent due to Monckeberg medial sclerosis producing incompressible vessels, while clinical signs are subjective and not accurate in posing definite diagnosis of CLI.
The investigators conducted a proof of concept study of the feasibility of microwave radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue loss.
详细描述
This is a prospective, multi-centre, trial designed to investigate the he feasibility and efficacy of microwave radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue loss. The study included 80 patients, equally divided in four groups. Group N: normal subjects; group DN: diabetic patients with verified neuropathic ulcers without vascular involvement; group DC: diabetic patients with CLI and group NDC: non-diabetic patients with CLI. All patients underwent MWR with the RTM -01-RES device (University of Bolton, UK) to record the mean internal tissue temperature of the foot. MWR is based on the principle that the intensity of radiation is proportional to tissue temperature. The specific device is not commercially available and has been developed to detect temperatures from internal tissues at microwave frequencies. Foot temperature measurements were performed as near as possible at the site of ulceration in patients of groups DN, DC and NDC and in various sites in subjects of control group N.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from both insulin and not insulin dependent diabetes mellitus.
- •Critical limb ischemia verified by both clinical examination, haemodynamic tests and digital subtraction angiography.
排除标准
- •Uncertainty regarding the absence of peripheral arterial disease in groups N and DN.
- •Uncertainty regarding the diagnosis of critical limb ischemia for patients in groups DC and NDC.
研究组 & 干预措施
Group N
Healthy volunteers without peripheral arterial disease according to clinical examination and Duplex ultrasound
干预措施: Tissue thermometry using non-invasive microwave radiometry device (Other)
Group DN
Patients suffering from diabetes and diabetic foot without vascular compromise according to clinical assessment continuous-wave Doppler and Duplex ultrasound
干预措施: Tissue thermometry using non-invasive microwave radiometry device (Other)
Group DC
Diabetic patients with Rutherford-Becker 5 or 6 critical limb ischemia, verified by clinical examination, abnormal continuous-wave Doppler or Duplex ultrasound and intra-arterial angiography.
干预措施: Tissue thermometry using non-invasive microwave radiometry device (Other)
Group NDC
Non diabetic patients with Rutherford-Becker 5 or 6 critical limb ischemia, verified by clinical examination, abnormal continuous-wave Doppler or Duplex ultrasound and intra-arterial angiography.
干预措施: Tissue thermometry using non-invasive microwave radiometry device (Other)
结局指标
主要结局
Mean foot tissue temperature
时间窗: 15 minutes
次要结局
未报告次要终点
研究者
Stavros Spiliopoulos
Assistant Professor of Radiology.
Attikon Hospital