Clinical trial NCT03002116: Microwave Radiometry Thermometry for the Diagnosis of Critical Limb Ischemia in Diabetic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Peripheral Arterial Disease
Ischaemic Neuropathy
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital of Patras
name: Bolton Research Foundation
First posted: 2016-12-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean foot tissue temperature
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rio
country: Greece
facility: Patras University Hospital
state: Achaia
city: Athens
country: Greece
facility: Attiko University General Hospital
state: Attiki
city: Bolton
country: United Kingdom
facility: Institute for Materials Research and Innovation, University of Bolton
Study officials:
affiliation: ATTIKO University General Hospital
name: Elias Brountzos, MD, PhD
role: STUDY_CHAIR
References: