RecruitingACTRN12619001173189

Non-contact monitoring of blood flow to the legs of people with diabetes (HeMo)

Determining the utility of a non-contact sensor for monitoring peripheral hemodynamics in patients with diabetes (HeMo).


Sponsor

South Western Sydney Local Health District

Enrollment

100 participants

Start Date

Aug 21, 2019

Study Type

Observational

Conditions

Summary

HeMo device consists of a stretchy fabric cuff worn on the lower leg. It fits snugly but is elastic and so does not apply any pressure on your leg. When you move your foot or leg, sensors in the cuff can detect changes in the way your blood is flowing. We hope to validate a device that will provide non-invasive diagnostic information more efficiently and easier than the current standard interventions.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Diabetes can damage blood vessels in the legs, leading to conditions like peripheral arterial disease (reduced blood flow) or chronic venous insufficiency (poor blood return). These conditions can be difficult to assess without specialised testing. The HeMo device is a stretchy fabric cuff worn on the lower leg that uses sensors to detect changes in blood flow when the foot or leg moves, offering a non-invasive and comfortable way to gather diagnostic information. This study tests whether the HeMo device can reliably measure blood flow in people with diabetes who have leg circulation problems. Participants wear the cuff while performing simple foot movements, and the results are compared to standard tests. The goal is to validate the device as a practical clinical tool. You may be eligible if you have Type 1 or Type 2 diabetes and have been diagnosed with or are being assessed for peripheral arterial disease or chronic venous insufficiency. People with active wounds on the lower limb that would prevent the device from being worn are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Use of off-the-shelf electro-resistive bands (non-contact sensors) and amplifier technology to monitor small hemodynamic changes in the lower limb due to arterial pulsation, which can be applicable to

Use of off-the-shelf electro-resistive bands (non-contact sensors) and amplifier technology to monitor small hemodynamic changes in the lower limb due to arterial pulsation, which can be applicable to detect peripheral arterial disease (PAD) or chronic venous insufficiency (CVI) in people with diabetes. The device (HeMo) is a fabric cuff worn on the lower leg, incorporating two contactless stretchable electro-resistive bands which will not be in contact with the skin. The bands do not apply any substantial pressure to the user. They fit snugly, but are elastic and by design, expand with the limb during inhalation for example. The technology is largely comprised of off-the-shelf components and is battery powered. Participants will be recruited if they consent for a one-off review and examination when they are referred for the standard of care investigations for either PAD or CVI. The complete duration a participant will be required to be present is approximately 1 hour and 15 minutes, dependant on the duration of time that the validated standard of care measures of PAD and CVI take to perform. These tests are performed while the patient is supine or prone on a medical examination bed. The device will be applied for a period of approximately 15 minutes, by either a technician who has designed the device, or an experienced sonographer. During these 15 minutes the participant will have the HeMo device on their lower leg, and will remain still for one minute while the device records the blood flow at rest. The participant then moves their foot up and down 10 times, at a rate demonstrated by the investigators. The participant will then remain still for 1 minute afterwards. This is repeated 3 times and takes approximately 15 minutes to complete.


Locations(1)

Liverpool Hospital - Liverpool

NSW, Australia

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ACTRN12619001173189


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