Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001156673p
Ethics application status
Not yet submitted
Date submitted
6/10/2023
Date registered
8/11/2023
Date last updated
8/11/2023
Date data sharing statement initially provided
8/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Can novel far-infrared (FIR) socks keep the feet warm in older adults?
Scientific title
Efficacy of novel far-infrared (FIR) socks in keeping the feet warm in older adults.
Secondary ID [1] 310742 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral vascular disease 331693 0
Condition category
Condition code
Cardiovascular 328433 328433 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials used:
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 Hematite
Sock 3: Socks made with fabric embedded with Indian Red Ochre
Conditions:
Condition 1: Sock embedded with Hematite,
Condition 2: Sock embedded with Indian Red Ochre,
Condition 3: Sock with no mineral additives (placebo).
We will test socks made from fabric manufactured with hematite 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 1 week between each test.

Procedure:
Participants will be asked to attend three sessions each lasting no longer than one hour. Each session will include the following:
Session 1: Participants will be specifically asked to rest for 10 minutes while barefoot before an assessor (MH/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 are taken, the participant will be provided with another 3 pairs of socks to use for the next 7 days. Participants will be asked to use the socks like they would their regular socks. Participants will be asked to keep a log of when and how long they wear the socks over the 7-day period.
Session 2: Participants will be provided with a questionnaire to evaluate their satisfaction of Sock 1. The test protocol from Session 1 will be repeated, but using Sock 2 instead.
Session 3: Participants will be provided with a questionnaire to evaluate Sock 2. The test protocol from session 1 will be repeated, but using Sock 3.
After a week, the participant will be asked to provide feedback for Sock 3 either via the telephone, or via email
Intervention code [1] 327151 0
Treatment: Devices
Comparator / control treatment
Control: Sock with no embedded inorganic minerals
Control group
Placebo

Outcomes
Primary outcome [1] 336269 0
Blood pressure in foot
Timepoint [1] 336269 0
baseline, after 30 mins per sock condition
Primary outcome [2] 336398 0
Toe pressure
Timepoint [2] 336398 0
baseline, after 30 mins per sock condition
Primary outcome [3] 336399 0
Temperature gradient
Timepoint [3] 336399 0
baseline, after 30 mins per sock condition
Secondary outcome [1] 427630 0
Patient Satisfaction
Timepoint [1] 427630 0
after 1 week of wearing each sock

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/CW and secondary outcomes (usability) will be analysed by NL. 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
1/03/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314973 0
Charities/Societies/Foundations
Name [1] 314973 0
Mornington Peninsula Post Polio Support Group
Country [1] 314973 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Primary and Allied Health Care Monash University, Peninsula Campus, Building G, Office 315, 47-49 Moorooduc Hwy, Frankston VIC 3199, Australia
Country
Australia
Secondary sponsor category [1] 316979 0
None
Name [1] 316979 0
Address [1] 316979 0
Country [1] 316979 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313948 0
Monash University Human Research Ethics Commitee
Ethics committee address [1] 313948 0
School of Primary and Allied Health Care Monash University, 47-49 Moorooduc Hwy, Frankston VIC 3199, Australia
Ethics committee country [1] 313948 0
Australia
Date submitted for ethics approval [1] 313948 0
08/01/2024
Approval date [1] 313948 0
Ethics approval number [1] 313948 0

Summary
Brief summary
Many older adults complain of cold feet, but little is being done to alleviate this problem because it is generally not considered limb-threatening. Fabrics functionalised with inorganic additive minerals reflect far-infrared (FIR) rays. Socks made from these ‘FIR’ fabrics have thermo-regulating properties in-vitro. They could reduce discomfort and complications related to cold feet in older adults, resulting in benefits such as reduction of thermal injuries from placing cold feet too close to a heat source or falls from wearing thick socks. We hypothesize that ‘FIR’ socks are effective in thermo-regulation and keeping feet warm.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129886 0
Dr Malia Ho
Address 129886 0
School of Primary and Allied Health Care Monash University, Peninsula Campus, Building G, Office 315, 47-49 Moorooduc Hwy, Frankston VIC 3199, Australia
Country 129886 0
Australia
Phone 129886 0
+61399044358
Fax 129886 0
Email 129886 0
[email protected]
Contact person for public queries
Name 129887 0
Dr Malia Ho
Address 129887 0
School of Primary and Allied Health Care Monash University, Peninsula Campus, Building G, Office 315, 47-49 Moorooduc Hwy, Frankston VIC 3199, Australia
Country 129887 0
Australia
Phone 129887 0
+61399044358
Fax 129887 0
Email 129887 0
[email protected]
Contact person for scientific queries
Name 129888 0
Dr Malia Ho
Address 129888 0
School of Primary and Allied Health Care Monash University, Peninsula Campus, Building G, Office 315, 47-49 Moorooduc Hwy, Frankston VIC 3199, Australia
Country 129888 0
Australia
Phone 129888 0
+61399044358
Fax 129888 0
Email 129888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20736Clinical study report  [email protected]



Results publications and other study-related documents

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