Microwave Radiometry Thermometry for the Diagnosis of Critical Limb Ischemia in Diabetic Patients

Peripheral Arterial Disease Clinical Trial

Official title:

Microwave Radiometry Thermometry for Non-invasive Diagnosis of Arterial Disease in Diabetic Patients With Suspected Critical Limb Ischemia: A Multi-centre Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002116
• Other study ID #: EB? 1310/10-2-16
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: April 2020
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetic Foot
• Ischaemic Neuropathy
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Tissue thermometry using non-invasive microwave radiometry device
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.

Locations

Country	Name	City	State
Greece	Attiko University General Hospital	Athens	Attiki
Greece	Patras University Hospital	Rio	Achaia
United Kingdom	Institute for Materials Research and Innovation, University of Bolton	Bolton

Sponsors (3)

Lead Sponsor	Collaborator
Attikon Hospital	Bolton Research Foundation, University Hospital of Patras

Countries where clinical trial is conducted

Greece,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean foot tissue temperature		15 minutes