ANZCTR - Registration

Registration number

ACTRN12618000668202

Ethics application status

Approved

Date submitted

5/02/2018

Date registered

24/04/2018

Date last updated

23/08/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Validating a new system for measuring pressure beneath feet lacking sensation

Scientific title

Validation of a portable multi-point pressure sensor module for plantar pressure measurement in neuropathic feet

Secondary ID [1]

Wound Innovations Study Number: WISC-02

Secondary ID [2]

Metro North Hospital and Health Service Study Number: TBA

Universal Trial Number (UTN)

U1111-1207-1960

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes Mellitus

Peripheral Neuropathy

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Neurological

Other neurological disorders

Skin

Other skin conditions

Intervention/exposure

Study type

Observational

Description of intervention(s) / exposure

The following will be performed one-to-one face-to-face with participants. All measurements will be conduced by the principal investigator and a co-investigator, both podiatrists. these measurements will take around 60 minutes and scheduled to occur immediately prior to the participants routine follow up at the high risk foot clinic.

Participants will complete a level walking test followed by a timed up-and-go test. This test sequence will be completed three times while wearing:
• portable multi-point pressure sensor module with sensors placed in four standardised locations – plantar 1st metatarsal head, 5th metatarsal head, plantar hallux and 5th metatarsal base to cover areas of frequent ulceration and to have a mix of digit, forefoot and midfoot measurements (PG standard)
• Portable multi-point pressure sensor module with one sensor placed at either the plantar hallux or 1st metatarsal head, and the other 3 sensors placed at anatomically relevant sites for the particular foot (PG anatomic). Anatomically relevant sites will be chosen by the Principal Researcher and would include sites of previous plantar ulceration, bony prominences exposed to plantar pressure, areas with evidence of hyperkeratosis of the skin or the apex of digits with a clawing deformity.
• Gold standard Novel pedar® -X insoles (Novel GmbH, München, Germany) that measures pressure across the entire plantar surface.
The order of portable multi-point pressure sensor module and Novel insoles will be randomized. Preferred walking speed will be measured (pedar®).
Level walking test: Participants will be level walking on a 30m straight pathway at their preferred speed, until the scientifically valid minimum of 12 midgait steps per foot is collected (Arts and Bus, 2011).
Timed up-and-go test: Participants will sit in a standard arm chair with a line marked 3 m in front of the chair. Participants will be briefed to stand up on the verbal signal “go”, walk to the line at their normal pace, turn, walk back to the chair and sit down again. Participants will be timed from the verbal “go” signal to when they have sat back down. This test will be repeated 3 times starting with the participants preferred foot (Podsiadlo and Richardson, 1991). Where time to perform these 3 tests varies by >5% outlier tests will be repeated up to a maximum of 6 tests.

Participants will get adequate rest between measurements. Participants will be asked if they have rested enough before a new measurement is started.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

Within subject comparison of peak plantar pressures as measured by the portable multi-point pressure sensor module (Pressure Guardian; ARTG Class 1 device entry 227634) and Gold standard measurment device (Novel pedar® -X insoles; ARTG Class 1 device entry 224585)

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Difference in peak plantar pressure measurements from the portable multi-point pressure sensor module compared to the gold-standard pedar®-X insole over a minimum of 12 mid-gait steps per foot at patients preferred walking speed wearing each pressure measurement system.

Timepoint [1]

Data will be collected for the duration of the over ground walking test along the 25-30m walkway until a minimum of 12 mid-gait steps per foot are recorded. Each 25-30m walking trial must be within 5% temporally for steps to be admissible for evaluation.

Secondary outcome [1]

Difference in peak plantar pressures from portable multi-point pressure sensor module compared to pedar®-X insole measured from the commencement of the timed up and go test.

Timepoint [1]

Data will be collected for the duration of the timed up and go tests. Timed up and go tests will be performed until three tests are completed within 5% temporally.

Secondary outcome [2]

Sensitivity values of the portable multi-point pressure sensor module for the following pressure cut-off points: 50, 100, 150, 200, 250, 300, 400, 500kPa.

Timepoint [2]

Data will be collected for the duration of the over ground walking test along the 25-30m walkway until a minimum of 12 mid-gait steps per foot are recorded. Each 25-30m walking trial must be within 5% temporally for steps to be admissible for evaluation.

Data will be collected for the duration of the timed up and go tests. Timed up and go tests will be performed until three tests are completed within 5% temporally.

Secondary outcome [3]

Analysis of occurrence of areas of high peak plantar pressure (greater than 150kPa and 200kPa) as measured by Pedar at sites not measured by Pressure Guardian across all tests.

Timepoint [3]

Data will be collected for the duration of the over ground walking test along the 25-30m walkway until a minimum of 12 mid-gait steps per foot are recorded. Each 25-30m walking trial must be within 5% temporally for steps to be admissible for evaluation.

Data will be collected for the duration of the timed up and go tests. Timed up and go tests will be performed until three tests are completed within 5% temporally.

Secondary outcome [4]

Specificity values of the portable multi-point pressure sensor module for the following pressure cut-off points: 50, 100, 150, 200, 250, 300, 400, 500kPa.

Timepoint [4]

Data will be collected for the duration of the over ground walking test along the 25-30m walkway until a minimum of 12 mid-gait steps per foot are recorded. Each 25-30m walking trial must be within 5% temporally for steps to be admissible for evaluation.

Data will be collected for the duration of the timed up and go tests. Timed up and go tests will be performed until three tests are completed within 5% temporally.

Eligibility

Key inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Diabetes mellitus Type 1 or Type 2
- Aged 18 years or older
- Peripheral Neuropathy, as determined using a 10-gram Semmes Weinstein monofilament, in line with criteria from the IWGDF (Schaper et al, 2016)
- Ability and willingness to cooperate with the study requirements

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Peripheral artery disease, this will be excluded by the presence of triphasic pulse waveforms or by a toe brachial pressure index >0.75 (Brownrig et al, 2016)
- Current diabetic foot ulcer
- Charcot neuroarthropathy
- Major amputation (i.e. above the ankle)
- Not able to walk for 30 meters without external support (e.g. crutches or walking frame)
- Unable to consent due to cognitive impairment or language limitations preventing understanding of provided information and hence capacity for informed consent.

Study design

Statistical methods / analysis

Differences between the pedar® insole and portable multi-point pressure sensor module for the primary and secondary study parameters will be assessed for each activity, using paired sample T-tests. All variables can be expected to have a normal distribution based on previous research (Maluf et al, 2004; Shah et al, 2012). Alpha will be set at 0.05, after which a Bonferroni correction will be applied.

Sensitivity and specificity values (positive predictive value / negative predictive value) of the portable multi-point pressure sensor module for the following pressure cut-off points: 50, 100, 150, 200, 300, 400, 500kPa

Frequency of instances of peak plantar pressure above 150kPa and 200kPa as measured by Pedar at sites not designated as key measurement sites for Pressure Guardian measurement.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

27/08/2018

Actual

Date of last participant enrolment

Anticipated

28/09/2018

Actual

Date of last data collection

Anticipated

31/10/2018

Actual

Sample size

Target

15

Accrual to date

0

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

North Lakes Health Precinct - North Lakes

Recruitment hospital [2]

Chermside Community Health Centre - Chermside

Recruitment hospital [3]

Caboolture Community Health Centre - Caboolture

Recruitment postcode(s) [1]

4509 - North Lakes

Recruitment postcode(s) [2]

4032 - Chermside

Recruitment postcode(s) [3]

4510 - Caboolture

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Metro North Hospital and Health Service

Country [1]

Australia

Primary sponsor type

Government body

Name

Metro North Hospital and Health Service

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Wound Innovations

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital Human Research and Ethics Committee

Ethics committee address [1]

Research office
Building 14
Rode Road
CHERMSIDE QLD 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/02/2018

Approval date [1]

18/04/2018

Ethics approval number [1]

HREC/18/QPCH/56

Summary

Brief summary

Foot ulcers are a frequent complication of 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 and this places them at high risk of developing foot ulceration. Clinical guidelines recommend the provision of protective footwear and pressure relieving insoles in the prevention of ulceration in the insensate foot. This needs to be guided by measuring pressure under the foot and subsequent modification of footwear or orthoses to provide optimal conditions for the prevention of ulceration.

Many systems exist to measure pressure beneath the foot to determine how effective pressure relieving strategies are. Current validated systems consist of high numbers of sensors but are expensive, which limits implementation into routine clinical practice, and can be difficult to use for untrained clinicians. In this study, we will test how well an affordable portable multi-point pressure sensor module measures pressure at key sites during normal, overground, walking and whilst changing from sitting to standing and back. We will compare this to a validated gold-standard reference pressure measurement system.

Clients of the Metro North Hospital and Health Services (MNHHS) community-based High-Risk Foot Clinic (HRFC) with peripheral neuropathy and no current foot ulcers will have pressure measurements taken prior to routine follow-up care. The results obtained from portable multi-point pressure sensor module will be compared to results from a laboratory insole testing system, which is considered to be “gold standard” for the measurements. Fifteen participants with diabetes mellitus type 1 or 2 and peripheral neuropathy will be included in the study. People with severe peripheral artery disease, a foot wound, severe foot deformities or unsteadiness in normal walking will be excluded from the study.

When the study is finished, we will know if the portable multi-point pressure sensor module gives similar results as “gold standard” measurement system.

Trial website

Public notes

Contacts

Principal investigator

Name

Mr Scott Lucadou-Wells

Address

North Lakes Health Precinct
9 Endeavour BLVD
North Lakes, QLD, 4509

Country

Australia

Phone

+61 7 3049 1298

Email

scott.lucadouwells@health.qld.gov.au

Contact person for public queries

Name

Scott Lucadou-Wells

Address

North Lakes Health Precinct
9 Endeavour BLVD
North Lakes, QLD, 4509

Country

Australia

Phone

+61 7 3049 1298

Email

scott.lucadouwells@health.qld.gov.au

Contact person for scientific queries

Name

Scott Lucadou-Wells

Address

North Lakes Health Precinct
9 Endeavour BLVD
North Lakes, QLD, 4509

Country

Australia

Phone

+61 7 3049 1298

Email

scott.lucadouwells@health.qld.gov.au

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