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Trial registered on ANZCTR


Registration number
ACTRN12616001717448
Ethics application status
Approved
Date submitted
8/12/2016
Date registered
14/12/2016
Date last updated
25/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Reliability and validity of biofeedback insoles for people with diabetes and peripheral neuropathy
Scientific title
Reliability and validity of biofeedback insoles for people with diabetes and peripheral neuropathy
Secondary ID [1] 290714 0
Nil
Universal Trial Number (UTN)
U1111-1190-6829
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 301280 0
diabetic neuropathy 301281 0
Condition category
Condition code
Metabolic and Endocrine 301038 301038 0 0
Diabetes
Neurological 301048 301048 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will use new biofeedback insoles (Bio Insole) as well as gold standard (Novel Pedar-X) insoles during various ambulatory activities,. Bio Insoles consist of a pressure sensing insole and attached electronic recording device. Patients will be tested in a single 90 min session, with Bio Insole or Pedar-X insoles used for approximately 50% of the time with the order of use randomised. Each patient will use both insoles. Activities consist of straight ground level walking, treadmill walking (normal speed, increased and decreased speed, ascent and descent), timed up and go test, starting and stopping on ground level walking and standing.. This is a single-centre, laboratory, within-subject design, observational study.
Intervention code [1] 296650 0
Not applicable
Comparator / control treatment
All participants will undertake various ambulatory activities using gold standard Pedar-X insoles (control) and new biofeedback insoles. The Pedar-X insoles are a TGA approved Class I medical device consisting of a pressure sensing insole and attached electronic recording device (GMDN #43829, ARTG identifier 224585). Participants will also stand on a calibrated force place (EMED, Novel GmbH, Munchen Germany) whilst wearing the insoles.
Control group
Active

Outcomes
Primary outcome [1] 300456 0
Reliability of centre of pressure displacement of Bio Insole compared to force plate
Timepoint [1] 300456 0
Over a period of 2 min of standing on the force plate with the insoles in shoes
Primary outcome [2] 300457 0
Validity of peak plantar pressure on Bio Insole relative to pressure obtained from Pedar-X insole
Timepoint [2] 300457 0
Over a minimum of 12 mid-gait steps per foot at patient's preferred walking speed wearing each insole
Primary outcome [3] 300494 0
Reliability of peak plantar pressure on Bio Insole relative to pressure obtained from Pedar-X insole
Timepoint [3] 300494 0
Over a minimum of 12 mid-gait steps per foot at patient's preferred walking speed wearing each insole
Secondary outcome [1] 330013 0
Pressure-time integral of Bio Insole compared to Pedar-X insole
Timepoint [1] 330013 0
Over a minimum of 12 mid-gait steps per foot at patient's preferred walking speed
Secondary outcome [2] 330014 0
Force-time integral of Bioinsole compared to Pedar-X insole
Timepoint [2] 330014 0
Over a minimum of 12 mid-gait steps per foot at patient's preferred walking speed
Secondary outcome [3] 330124 0
Validity of centre of pressure displacement of Bio Insole compared to force plate
Timepoint [3] 330124 0
over a period of 2 min of standing on the force plate with the insoles in shoes

Eligibility
Key inclusion criteria
- Diabetes mellitus type 1 or 2
- Aged 18 years or older
- Peripheral Neuropathy (as determined using a 10-gram Semmes Weinstein monofilament, in line with criteria from the International Working Group on the Diabetic Foot (IWGDF; Schaper et al, 2016)
- Ability and willingness to cooperate with the study requirements
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Peripheral artery disease, determined by a toe pressure <30mmHg (Hinchliffe et al, 2016)
- Diabetic foot ulcer
- Charcot neuroarthropathy
- Major amputation (i.e. above the ankle)
- Not able to walk for 30m. without external support (e.g. crutches)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Differences between the force plate / Pedar insole and the new insole for the primary study parameters will be assessed for each activity, using student’s T-tests. All variables can be expected to have a normal distribution based on previous research. Alpha will be set at 0.05, after which a Bonferroni correction will be applied.
Differences between the Pedar insole and the new insole for the secondary study parameters will be assessed for each activity, using student’s T-tests. All variables can be expected to have a normal distribution based on previous research. Alpha will be set at 0.05, after which a Bonferroni correction will be applied.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 14818 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 295143 0
Other
Name [1] 295143 0
Wound Management Innovation CRC
Address [1] 295143 0
Oxley House, Level 2, 25 Donkin St
West End QLD 4101
PO BOX 2375 Toowong DC, QLD 4066
Country [1] 295143 0
Australia
Primary sponsor type
Other
Name
Wound Management Innovation CRC
Address
Oxley House, Level 2, 25 Donkin St
West End QLD 4101
PO BOX 2375 Toowong DC, QLD 4066
Country
Australia
Secondary sponsor category [1] 293962 0
None
Name [1] 293962 0
Address [1] 293962 0
Country [1] 293962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296489 0
QUT University Human Research Ethics Committee
Ethics committee address [1] 296489 0
Ethics committee country [1] 296489 0
Australia
Date submitted for ethics approval [1] 296489 0
Approval date [1] 296489 0
03/11/2016
Ethics approval number [1] 296489 0
1600000888

Summary
Brief summary
Foot ulcers are a frequent problem in people with diabetes. These wounds can be serious, and may result in amputation or even death, if left untreated. A frequent cause of these wounds is high pressure under the foot.
Prevention of such wounds is of great importance. This is especially the case in people who cannot feel touch or pressure on their foot, which is called peripheral neuropathy, or an insensate foot. Reduced foot sensation can prevent people from noticing when high pressure develops. Early detection of high pressure in people with an insensate foot can be beneficial in avoiding these wounds. When high pressure is detected earlier, treatment can start earlier, to avoid ulcers forming. For this, pressure needs to be monitored on a daily basis.
The long term goal of this project is to develop an insole for people with diabetes to measure pressure on the soles of the feet during daily activities. The current study will test how well the insoles measure pressure during a series of everyday activities. We will compare this to laboratory pressure measurement systems in the QUT Health Clinic.
Participants will visit the QUT Health Clinic once. The results obtained from the new insoles will be compared to results from a laboratory insole testing system and a force plate, which are considered to be “gold standard” for some of the measurements. Fifteen participants with diabetes mellitus type 1 or 2 and peripheral neuropathy will be included in the study. People with vascular disease, a foot wound, or severe foot deformities will be excluded from the study.
When the study is finished, we know if the new insoles give similar results as “gold standard” measurement system. We also know if insoles give similar results at similar steps. This will tell us if the insoles have potential to be used in daily life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71010 0
Dr Jaap van Netten
Address 71010 0
School of Clinical Sciences
Faculty of Health, Level 6, O Block, D Wing
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059

Country 71010 0
Australia
Phone 71010 0
+61730886666
Fax 71010 0
Email 71010 0
jaap.vannetten@qut.edu.au
Contact person for public queries
Name 71011 0
Dr Jaap van Netten
Address 71011 0
School of Clinical Sciences
Faculty of Health, Level 6, O Block, D Wing
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 71011 0
Australia
Phone 71011 0
+61730886666
Fax 71011 0
Email 71011 0
jaap.vannetten@qut.edu.au
Contact person for scientific queries
Name 71012 0
Dr Jaap van Netten
Address 71012 0
School of Clinical Sciences
Faculty of Health, Level 6, O Block, D Wing
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 71012 0
Australia
Phone 71012 0
+61730886666
Fax 71012 0
Email 71012 0
jaap.vannetten@qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary