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

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.

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Key information

Conditions

Diabetic Foot Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Ischaemic Neuropathy Leg Ulcer Peripheral Arterial Disease Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patras University Hospital, Rio, Achaia, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tissue thermometry using non-invasive microwave radiometry device

Other

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.

Primary outcomes

Mean foot tissue temperature

Time frame: 15 minutes

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Collaborators

Bolton Research Foundation
University Hospital of Patras

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Dec 23, 2016
Registry last updated: Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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