Microwave Radiometry Thermometry for the Diagnosis of Critical Limb Ischemia in Diabetic Patients
Condition: Diabetic Foot; Peripheral Arterial Disease; Ischaemic Neuropathy
MeSH terms: Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Tissue thermometry using non-invasive microwave radiometry device
Intervention type(s): Other
Intervention description(s): In Patients included in the four study groups underwent non-invasive tissue thermometry using microwave radiometry (MWR) device, at the same room temperature and with the same methodology. Specifically, the probe of the RTM-01-RES (University of Bolton, UK) device was by applied on the surface of the foot tissue at an angle of 90o degrees for approximately 8 to 10 seconds in pre-determined sites. Measurements were performed by two independent operators. Three measurements were taken from each site. The mean value of the three values calculated by the 2 different operators was used for the analysis. Measurements were recorded using a dedicated software.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic