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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] 301328 0
Nil KNown
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 317526 0
History of plantar forefoot ulcers 317527 0
Increased barefoot plantar pressure, 317528 0
Neuropathy 317679 0
Forefoot deformity 317680 0
At risk of plantar forefoot ulcers 317681 0
Partial amputation 317682 0
Unilateral trans-met amputation 317683 0
Peripheral arterial disease 317684 0
Condition category
Condition code
Metabolic and Endocrine 315625 315625 0 0
Diabetes
Cardiovascular 315758 315758 0 0
Other cardiovascular diseases
Musculoskeletal 315759 315759 0 0
Other muscular and skeletal disorders
Injuries and Accidents 315760 315760 0 0
Other injuries and accidents
Neurological 315761 315761 0 0
Other neurological disorders
Skin 315762 315762 0 0
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] 317631 0
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] 323866 0
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] 323866 0
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] 324185 0
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] 324185 0
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.
Secondary outcome [1] 383088 0
The secondary outcome is adherence to footwear and insole (to be measured by using Orthotimer in-shoe sensor).
Timepoint [1] 383088 0
2 weeks after the initial fitting and then at 6 and 10 weeks.
Secondary outcome [2] 383457 0
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] 383457 0
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?
No
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
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16722 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 16723 0
St George Hospital - Kogarah
Recruitment hospital [3] 16724 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 30324 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 30325 0
2217 - Kogarah
Recruitment postcode(s) [3] 30326 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 305762 0
Hospital
Name [1] 305762 0
Nepean Hospital
Country [1] 305762 0
Australia
Funding source category [2] 305847 0
University
Name [2] 305847 0
Southern Cross University
Country [2] 305847 0
Australia
Funding source category [3] 305848 0
Hospital
Name [3] 305848 0
St Vincent's Hospital Sydney
Country [3] 305848 0
Australia
Funding source category [4] 305849 0
Hospital
Name [4] 305849 0
St George Hospital
Country [4] 305849 0
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] 306198 0
Commercial sector/Industry
Name [1] 306198 0
Foot Balance Technology Pty Ltd
Address [1] 306198 0
19/1A Ashley Lane, Westmead, NSW 2145
Country [1] 306198 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306035 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 306035 0
Ethics committee country [1] 306035 0
Australia
Date submitted for ethics approval [1] 306035 0
18/05/2020
Approval date [1] 306035 0
Ethics approval number [1] 306035 0

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

Contacts
Principal investigator
Name 102498 0
Mr Sayed Ahmed
Address 102498 0
School of Health & Human Science
Southern Cross University
Southern Cross Drive
Bilinga, QLD 4225,
Country 102498 0
Australia
Phone 102498 0
+61 425148314
Fax 102498 0
Email 102498 0
[email protected]
Contact person for public queries
Name 102499 0
Sayed Ahmed
Address 102499 0
School of Health & Human Science
Southern Cross University
Southern Cross Drive
Bilinga, QLD 4225,
Country 102499 0
Australia
Phone 102499 0
+61 425148314
Fax 102499 0
Email 102499 0
[email protected]
Contact person for scientific queries
Name 102500 0
Sayed Ahmed
Address 102500 0
School of Health & Human Science
Southern Cross University
Southern Cross Drive
Bilinga, QLD 4225,
Country 102500 0
Australia
Phone 102500 0
+61 425148314
Fax 102500 0
Email 102500 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?
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.TypeCitationLinkEmailOther DetailsAttachment
8012Study protocol  [email protected] 379860-(Uploaded-19-05-2020-17-54-17)-Study-related document.docx
8014Informed 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
SourceTitleYear of PublicationDOI
EmbaseFootwear 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.2022https://dx.doi.org/10.1186/s13063-022-06968-5
N.B. These documents automatically identified may not have been verified by the study sponsor.