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Trial registered on ANZCTR


Registration number
ACTRN12619001173189
Ethics application status
Approved
Date submitted
6/08/2019
Date registered
20/08/2019
Date last updated
13/04/2021
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-contact monitoring of blood flow to the legs of people with diabetes (HeMo)
Scientific title
Determining the utility of a non-contact sensor for monitoring peripheral hemodynamics in patients with diabetes (HeMo).
Secondary ID [1] 298714 0
Nil known
Universal Trial Number (UTN)
U1111-1236-8700
Trial acronym
HeMo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 313618 0
Chronic venous insufficiency 313619 0
Peripheral arterial disease 313620 0
Condition category
Condition code
Metabolic and Endocrine 312052 312052 0 0
Diabetes
Cardiovascular 312053 312053 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 315131 0
Not applicable
Comparator / control treatment
Both the intervention/exposure and the comparator/control treatment will occur at the same timepoint - the one session the participant will be reviewed at.

Standard Validated measures of PAD and CVI:
- Ankle Brachial Index (ABI) measurement
- Toe Brachial Index (TBI) measurement
- Toe photoplethymography (PPG) measurement
- Ankle Light Reflection Rheography (LRR) measurement
- Duplex scan (venous incompetence ultrasound) measurement
- Plantar Acceleration Time
Control group
Active

Outcomes
Primary outcome [1] 320876 0
To assess the efficacy of lower limb electro resistive bands (HeMo device) to non-invasively monitor peripheral haemodynamic that include: blood volume changes in the limb and arterial pulsation volume through validation against the standard currently used measurement techniques (secondary outcomes).
Timepoint [1] 320876 0
Following recruitment of all participants
Secondary outcome [1] 373203 0
Compare and correlate HeMo data to standard ABI (Ankle Brachial Index) measurement to assess the validity of the HeMo device
Timepoint [1] 373203 0
Following recruitment of all participants
Secondary outcome [2] 373204 0
Compare and correlate HeMo data to standard TBI (Toe Brachial Index) measurement to assess the validity of the HeMo device
Timepoint [2] 373204 0
Following recruitment of all participants
Secondary outcome [3] 373205 0
Compare and correlate HeMo data to standard toe PPG (Photoplethymography) to assess the validity of the HeMo device
Timepoint [3] 373205 0
Following recruitment of all participants
Secondary outcome [4] 373206 0
Compare and correlate HeMo data to respiration measurement to assess the validity of HeMo device.
This will be assessed by counting the number of breaths in one minute, and also through wearing a contactless sensor capable of simultaneous monitoring of respiration and cardiac activity.
Timepoint [4] 373206 0
Following recruitment of all participants
Secondary outcome [5] 373207 0
Compare and correlate HeMo data to standard ankle LRR (Light Reflection Rheography) measurement to assess the validity of the HeMo device
Timepoint [5] 373207 0
Following recruitment of all participants
Secondary outcome [6] 373208 0
Compare and correlate the HeMo data to duplex scan (venous incompetence ultrasound) measurement to assess the validity of the HeMo device
Timepoint [6] 373208 0
Following recruitment of all participants

Eligibility
Key inclusion criteria
Type 1 or type 2 diabetes mellitus
Peripheral arterial disease (PAD) or Chronic Venous Insufficiency (CVI) indicated
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active wounds on parts of the lower extremity which preclude the ability to perform ABIs/TBIs or use of HeMo

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Pilot study comparing HeMo device to current vascular methods for diagnosing PAD or CVI. According to Liao (2009) a sample size of at least 32 is recommended and the concordance acceptance criteria requires all pair differences falling within the agreement window. This means each measurement pair falls within the predetermined agreement interval, defined by a discordance rate of 0.05 and a tolerance probability of 80%. A tolerance of 90% may be achieved, which requires a sample size of 45.

Clinical metrics, descriptive and HeMo data will be analysed with Statistical Package for Social Sciences Version 23 (SPSS). For all comparisons and modelling the level of significance will be set at 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
21/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
100
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14444 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 27458 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 303266 0
Other
Name [1] 303266 0
South West Sydney Limb Preservation and Wound Research
Country [1] 303266 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Liverpool Hospital
75 Elizabeth Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 303274 0
Other
Name [1] 303274 0
South West Sydney Limb Preservation and Wound Research
Address [1] 303274 0
Ingham Institute of Applied Medical Research
1 Campbell Street, Liverpool, NSW 2170
Country [1] 303274 0
Australia
Other collaborator category [1] 280893 0
University
Name [1] 280893 0
Western Sydney University, MARCS Institute
Address [1] 280893 0
Locked bag 1797
Penrith NSW 2751
Country [1] 280893 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303805 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 303805 0
Ethics committee country [1] 303805 0
Australia
Date submitted for ethics approval [1] 303805 0
18/12/2018
Approval date [1] 303805 0
15/05/2019
Ethics approval number [1] 303805 0
2018/ETH00532 - STE00411

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94870 0
Dr Matthew Malone
Address 94870 0
Ingham Institute for Applied Medical Research
1 Campbell Street, Liverpool NSW 2170
Country 94870 0
Australia
Phone 94870 0
+61 2 8738 9260
Fax 94870 0
+61 2 8738 8297
Email 94870 0
matthew.malone@westernsydney.edu.au
Contact person for public queries
Name 94871 0
Alyson France
Address 94871 0
Ingham Institute for Applied Medical Research
1 Campbell Street, Liverpool NSW 2170
Country 94871 0
Australia
Phone 94871 0
+61 2 8738 9361
Fax 94871 0
+61 2 8738 8297
Email 94871 0
Alyson.France@health.nsw.gov.au
Contact person for scientific queries
Name 94872 0
Matthew Malone
Address 94872 0
Ingham Institute for Applied Medical Research
1 Campbell Street, Liverpool NSW 2170
Country 94872 0
Australia
Phone 94872 0
+61 2 8738 9260
Fax 94872 0
+61 2 8738 8297
Email 94872 0
matthew.malone@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Preliminary data on as yet unvalidated device.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.