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Trial registered on ANZCTR

Registration number

ACTRN12620000699965p

Ethics application status

Submitted, not yet approved

Date submitted

19/05/2020

Date registered

23/06/2020

Date last updated

23/06/2020

Date data sharing statement initially provided

23/06/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes; - A series of single participant trials.

Scientific title

Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes; - A series of N-of-1 trials.

Secondary ID [1]

Nil KNown

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Diabetes

History of plantar forefoot ulcers

Increased barefoot plantar pressure,

Neuropathy

Forefoot deformity

At risk of plantar forefoot ulcers

Partial amputation

Unilateral trans-met amputation

Peripheral arterial disease

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Cardiovascular

Other cardiovascular diseases

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

Other injuries and accidents

Neurological

Other neurological disorders

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Each participant is required to commit to making him/herself available for the initial assessment and follow up appointments. This period can be between 10 to 12 weeks from the initial fitting. This is recommended based on common practice within the high-risk foot services and pedorthic services for offloading. Both the clinicians and participants can have a better understanding of the efficacy of offloading, walking comfort and aesthetics of the devices by this time period. Participants are also required to select a preferred style of footwear and report on the activities for which they intend to wear the footwear. The footwear will properly accommodate the foot and the upper will be softer and seam-free, so there is no pressure or rubbing from the upper. The outsole will have appropriate rocker profile to adequately offload plantar pressure at the forefoot. The insole will have adequate contact with the plantar surface of the foot with the configuration of arch support, metatarsal dome or bar, Plastazote top cover, Poron mid-layer and EVA base. Participants need to wear footwear and insoles as directed by the researcher. The common recommendation is to wear the footwear for half-an-hour on the first day, an hour for the 2nd day and an hour increase on each day. After a week, the participants will be wearing the footwear and insole for 8 hours and increase the wearing period further if there is no rubbing, redness or discomfort. Then they will be instructed to wear them most of the time they weight-bear. There will be an in-shoe sensor attached to the insoles to measure wearing period over the study periods. The participants will also undergo in-shoe plantar pressure measurements at each fitting and review appointments where they need to walk up to 12 meters at a self-selected pace that represents their regular pace of walking and consistent during each measurement. F-Scan sensors will be calibrated at “Walk” calibration and bodyweight of the participant will be recorded each time during the analysis.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The control will be participants’ existing footwear, insoles in the form of regular, orthopedic or post-op footwear. This will form the baseline data of in-shoe plantar pressure measurements to be compared against in the new footwear and insole to evaluate off-loading efficacy. This will be measured at the initial assessment session to form the baseline data in that single session. Hence, the choice of a control arm is essential, but in this case, the patient is their own control.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in diabetic neuropathic plantar forefoot ulcer occurrence.
In-shoe plantar pressure analysis will be done to determine the efficacy of the devices and the pressure values can lead to a conclusion. The desired peak plantar pressure value is either <200 kPa or >30% reduction from the control devices. This value is recommended by the International Working Group on the Diabetic Foot (IWGDF)'s recent guideline.

Timepoint [1]

Primary timepoint is three to four months from the recruitment step.
Within this time, participants' footwear and insoles will be assessed for pressure offloading efficacy with any modifications required and adequate wear test.

Primary outcome [2]

Change in diabetic neuropathic plantar forefoot ulcer recurrence.
In-shoe plantar pressure analysis will be done to determine the efficacy of the devices and the pressure values can lead to a conclusion. The desired peak plantar pressure value is either <200 kPa or >30% reduction from the control devices. This value is recommended by the International Working Group on the Diabetic Foot (IWGDF)'s recent guideline.

Timepoint [2]

Secondary outcome [1]

The secondary outcome is adherence to footwear and insole (to be measured by using Orthotimer in-shoe sensor).

Timepoint [1]

2 weeks after the initial fitting and then at 6 and 10 weeks.

Secondary outcome [2]

Participant’s satisfaction with the provided footwear and insoles (in terms of walking convenience and aesthetics) to be measured by using a Likert scale

Timepoint [2]

At the initial fitting stage and after 2, 6 and 10 weeks since initial fitting

Eligibility

Key inclusion criteria

Participants will be adults ( over 18 years of age) with type-1 or type-2 diabetes, peripheral neuropathy and recently healed plantar forefoot ulcer. Participants may have at least one or more forefoot deformities such as claw/hammer toes, cross over toes, hallux valgus, hallux amputation, limited joint mobility, pes planus or, pes cavus and bony prominences at metatarsal heads. Participants will have required referral for orthopedic footwear (either custom-made or prefabricated medical grade footwear with or without modification) and custom-made insoles, and have adequate English communication skills to provide informed consent and comprehend the study procedures.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria will be bilateral amputation (proximal to the trans-metatarsal joint), active or inactive Charcot foot, healed heel ulcers, midfoot deformities, use of walking aid for off-loading the foot, or severe illness, such that the participant may not survive for the study period.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Data will be analysed by using Analysis of variance (ANOVA), and a two-way ANOVA will be performed for the statistical analysis.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/08/2020

Actual

Date of last participant enrolment

Anticipated

30/11/2020

Actual

Date of last data collection

Anticipated

5/03/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [2]

St George Hospital - Kogarah

Recruitment hospital [3]

Nepean Hospital - Kingswood

Recruitment postcode(s) [1]

2010 - Darlinghurst

Recruitment postcode(s) [2]

2217 - Kogarah

Recruitment postcode(s) [3]

2747 - Kingswood

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Nepean Hospital

Address [1]

Offloading Clinic, Aged care and rehab centre, Nepean Hospital.
Derby Street, Kingswood, NSW 2747

Country [1]

Australia

Funding source category [2]

University

Name [2]

Southern Cross University

Address [2]

School of Health and Human Sciences, Southern Cross University, Bilinga, Queensland, 4225, Australia

Country [2]

Australia

Funding source category [3]

Hospital

Name [3]

St Vincent's Hospital Sydney

Address [3]

St Vincent’s Hospital High-Risk Foot Service & Garvan Institute of Medical Research
384 Victoria Street, Darlinghurst Sydney NSW 2010

Country [3]

Australia

Funding source category [4]

Hospital

Name [4]

St George Hospital

Address [4]

High-Risk Foot Service, The St George Hospital Podiatry Department,
Level 1 Burt Neilsen Wing, Gray Street, Kogarah NSW 2117

Country [4]

Australia

Primary sponsor type

University

Name

Southern Cross University

Address

School of Health & Human Science,
Southern Cross Drive, Bilinga, QLD 4225

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Foot Balance Technology Pty Ltd

Address [1]

19/1A Ashley Lane, Westmead, NSW 2145

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Southern Cross University Human Research Ethics Committee

Ethics committee address [1]

 The Ethics Officer, Southern Cross University, PO Box 157, Lismore NSW 2480.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/05/2020

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Foot ulcers are a common consequence of diabetes due to the development of peripheral neuropathy, peripheral vascular disease, limited joint mobility and foot deformity. Nearly 34% of persons with diabetes will develop a foot ulcer in their lifetime. This can lead to infection and amputation. Diabetes is the main reason for non-traumatic amputation. 
 
Reducing plantar pressures is considered a key factor for wound healing and prevention of ulcer recurrence. Footwear and insoles are an important treatment modality for off-loading these pressures. 

There is no existing, evidence-based recommendation for overall footwear design with all technical specifications to off-load the neuropathic diabetic foot. Hence this study will explore the design and modification features of footwear and insole that can reduce risk of neuropathic plantar forefoot ulceration in people with diabetes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Sayed Ahmed

Address

School of Health & Human Science
Southern Cross University
Southern Cross Drive
Bilinga, QLD 4225,

Country

Australia

Phone

+61 425148314

Fax

[email protected]

Contact person for public queries

Name

Sayed Ahmed

Address

School of Health & Human Science
Southern Cross University
Southern Cross Drive
Bilinga, QLD 4225,

Country

Australia

Phone

+61 425148314

Fax

[email protected]

Contact person for scientific queries

Name

Sayed Ahmed

Address

School of Health & Human Science
Southern Cross University
Southern Cross Drive
Bilinga, QLD 4225,

Country

Australia

Phone

+61 425148314

Fax

[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?

De-identified data for analysis

When will data be available (start and end dates)?

From the end of the trial to the next fifteen years

Available to whom?

Researchers only

Available for what types of analyses?

Only to achieve the aims in the approved proposal, for IPD meta-analyses

How or where can data be obtained?

Access subject to approvals by Principal Investigator. Email: [email protected] and [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8012	Study protocol			[email protected]		379860-(Uploaded-19-05-2020-17-54-17)-Study-related document.docx
8014	Informed consent form				Uploaded	379860-(Uploaded-19-05-2020-17-54-43)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes: a series of N-of-1 trial study protocol.	2022	https://dx.doi.org/10.1186/s13063-022-06968-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically