Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000407493
Ethics application status
Approved
Date submitted
28/04/2025
Date registered
5/05/2025
Date last updated
5/05/2025
Date data sharing statement initially provided
5/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Can novel far-infrared (FIR) socks improve the blood flow in the lower limbs of older adults?
Scientific title
The effectiveness of Far Infra Red socks on the blood flow of the lower limbs
Secondary ID [1] 314285 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Vascular Disease 337227 0
Condition category
Condition code
Cardiovascular 333636 333636 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 types of fabrics made into socks
Sock 1: Socks made with fabric with no added inorganic minerals (placebo)
Sock 2: Socks made with fabric embedded with Caesium Tungstate 2%
Sock 3: Socks made with fabric embedded with Indian Red Ochre 2%
Conditions:
Condition 1: Sock embedded with Caesium Tungstate 2%
Condition 2: Sock embedded with Indian Red Ochre 2%
Condition 3: Sock with no mineral additives (placebo).

We will test socks made from fabric manufactured with Caesium Tungstate or Indian Red Ochre minerals. Both of these materials emit Far Infrared (FIR) rays in the 4-16 µm range. Initial testing at Nanyang Technological University Materials Engineering Laboratory has determined that these two minerals have optimal heat retention properties when exposed to an infra-red lamp heat source at 34 degrees. The socks will be differentiated in pattern, but neither the assessor nor the participant will know which sock is which (doubleblind).
Only one research team member knows the minerals that are embedded in each sock type. There will be a wash out period of 30 minutes between each test.

Procedure:
Participants will be asked to attend one session lasting no longer than three hour. Each session will include the following:
Participants will be specifically asked to rest for 10 minutes while barefoot before an assessor (TN/DS) measures the Ankle Brachial Index, and Toe pressure using a standard clinical doppler vascular assessment kit and temperature gradient (skin temperature over the knee, anterior ankle, ball of the great toe ) using a standard non-contact thermometer. The assessor will place the test sock (Sock1) on the participant. After 30 mins, the vascular assessments will be repeated.
After the measurements for Sock 1 are taken, the participant will be provided with a 10 minutes break and the same test will be repeated again with the other 2 test socks (Sock 2 and 3) separately.
During the session when each of the socks is donned on,the research assistant (TN) will be observing participants to ensure that they have kept the test socks on for that entire period of 30 minutes.
Intervention code [1] 330896 0
Treatment: Devices
Comparator / control treatment
Control: Sock with no embedded inorganic minerals
Control group
Placebo

Outcomes
Primary outcome [1] 341211 0
Blood pressure in feet
Timepoint [1] 341211 0
Baseline and after 30 mins per sock condition
Primary outcome [2] 341212 0
Toe Pressure
Timepoint [2] 341212 0
baseline and after 30 mins per sock condition
Secondary outcome [1] 446792 0
nil
Timepoint [1] 446792 0
nil

Eligibility
Key inclusion criteria
65 years of age and over
Self reported cold feet
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons with known critical limb ischaemia, current ulcers in the foot and leg.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Primary outcomes (effectiveness of sock in thermo-regulation) will be analysed by MH. Comparisons between conditions will be undertaken using a linear mixed model analysis with conditions treated as a fixed effect and participant and trial number within a condition as a random effect. Trials will be nested within participants. A balanced Latin-square design will allow for comparison between outcomes from the different sock conditions, without the requirement for adjustment for order effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318804 0
Charities/Societies/Foundations
Name [1] 318804 0
Mornington Peninsula Post Polio Support Group
Country [1] 318804 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sportsmaster
Address
Country
Russian Federation
Secondary sponsor category [1] 321247 0
None
Name [1] 321247 0
Address [1] 321247 0
Country [1] 321247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317412 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 317412 0
Ethics committee country [1] 317412 0
Australia
Date submitted for ethics approval [1] 317412 0
30/04/2025
Approval date [1] 317412 0
01/05/2025
Ethics approval number [1] 317412 0

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

Contacts
Principal investigator
Name 140978 0
Dr Malia Ho
Address 140978 0
Monash University School of Primary and Allied Health Care Monash University, Peninsula Campus; Building G, Office 315, 47-49 Moorooduc Hwy, Frankston VIC 3199, Australia
Country 140978 0
Australia
Phone 140978 0
+61399044358
Fax 140978 0
Email 140978 0
[email protected]
Contact person for public queries
Name 140979 0
Malia Ho
Address 140979 0
Monash University School of Primary and Allied Health Care Monash University, Peninsula Campus; Building G, Office 315, 47-49 Moorooduc Hwy, Frankston VIC 3199, Australia
Country 140979 0
Australia
Phone 140979 0
+61399044358
Fax 140979 0
Email 140979 0
[email protected]
Contact person for scientific queries
Name 140980 0
Malia Ho
Address 140980 0
Monash University School of Primary and Allied Health Care Monash University, Peninsula Campus; Building G, Office 315, 47-49 Moorooduc Hwy, Frankston VIC 3199, Australia
Country 140980 0
Australia
Phone 140980 0
+61399044358
Fax 140980 0
Email 140980 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
• case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• • individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24674Clinical study report  [email protected]



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.