- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03002116
Microwave Radiometry Thermometry for the Diagnosis of Critical Limb Ischemia in Diabetic Patients
Microwave Radiometry Thermometry for Non-invasive Diagnosis of Arterial Disease in Diabetic Patients With Suspected Critical Limb Ischemia: A Multi-centre Feasibility Study
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Achaia
-
Rio, Achaia, Greece, 26500
- Patras University Hospital
-
-
Attiki
-
Athens, Attiki, Greece, 12461
- Attiko University General Hospital
-
-
-
-
-
Bolton, United Kingdom, BL3 5AB
- Institute for Materials Research and Innovation, University of Bolton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group N
Healthy volunteers without peripheral arterial disease according to clinical examination and Duplex ultrasound
|
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.
|
Experimental: Group DN
Patients suffering from diabetes and diabetic foot without vascular compromise according to clinical assessment continuous-wave Doppler and Duplex ultrasound
|
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.
|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean foot tissue temperature
Time Frame: 15 minutes
|
15 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Elias Brountzos, MD, PhD, Attiko University General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Atherosclerosis
- Foot Ulcer
- Diabetic Foot
- Ischemia
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
Other Study ID Numbers
- EBΔ 1310/10-2-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot
-
University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
-
Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
-
Integra LifeSciences CorporationMayo Clinic; Temple University; Samuel Merritt University; New York College of... and other collaboratorsCompletedFoot Ulcers, DiabeticUnited States
-
Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
-
Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
-
Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
-
University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan
-
University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
-
HealthpointCompletedDiabetic Foot Ulcers | Diabetic Foot WoundsUnited States, Canada
-
HealthpointCompleted
Clinical Trials on Tissue thermometry using non-invasive microwave radiometry device
-
St. Justine's HospitalFonds de la Recherche en Santé du Québec; Dymedso Inc.; Réseau de Recherche en...UnknownCOVID-19 | Physiotherapy
-
University of ChicagoCompletedShock | Acute Respiratory Distress Syndrome | Ventilatory Failure | Cardiogenic Pulmonary EdemaUnited States
-
University of Wisconsin, MadisonCompletedNoninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain InjuryBrain Injuries, TraumaticUnited States