Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001111662
Ethics application status
Approved
Date submitted
29/09/2023
Date registered
25/10/2023
Date last updated
5/04/2024
Date data sharing statement initially provided
25/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
SENSATE trial: Smart Eating and Nutrition Supports solving Amputations, Toe loss and Exudate.
Scientific title
Feasibility and acceptability of a personalised wound healing nutrition intervention in those living with diabetes-related foot ulcerations: a pilot randomised controlled trial
Secondary ID [1] 310686 0
None
Universal Trial Number (UTN)
Trial acronym
SENSATE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes-related foot ulcer
 331632 0
Condition category
Condition code
Metabolic and Endocrine 328360 328360 0 0
Diabetes
Diet and Nutrition 328361 328361 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be provided one initial dietitian consult (duration of 30 minutes) and 2 review sessions (30 minutes) with the dietitian. The consultations will be one-on-one and face-to-face with the dietitian following their podiatry appointment. The initial consult will be conducted during week 1 of the intervention phase, with the review sessions occurring on week’s 2 and week 4. The dietitian consults will include personalised Medical Nutrition Therapy (MNT) combined with motivational interviewing (Capabilities, Opportunities, Motivation and Behaviour model (COMB-B model) and the Personalised Nutrition Questionnaire (PNQ)). The Academy of Nutrition and Dietetics reports MNT refers to the evidence-based use of the Nutrition Care Process (nutrition assessment, nutrition diagnosis, nutrition intervention, and nutrition monitoring and evaluation) which typically results in prevention, delayed progression or management of diseases/conditions. The intervention group will also receive 2 food boxes containing food important for wound healing at baseline (1 box) and week 4 (1 box), and a $25 voucher at baseline, week 2, week 4 and week 6 at their podiatry appointment to compensate them for their time and assist with food costs. All participants will be provided standardised podiatry care which will include debridement, wound dressing and pressure offloading (standard care). To monitor adherence to the intervention, we will review and extract data required out of medical records.
Intervention code [1] 327107 0
Treatment: Other
Comparator / control treatment
Participants in the waitlist group will be provided the Australian Guide to Healthy Eating leaflet, a $25 voucher will be provided during the intervention phase at each point of contact (baseline, week 2, week 4 and week 6 at their podiatry appointment). At the end of the six-week intervention, the waitlist group will be provided the highly personalised dietary intervention, including the food box at baseline and week 4, and medical nutrition therapy at baseline, week 2 and week 4. All participants will be provided standardised podiatry care which will include debridement, wound dressing and pressure offloading (standard care).
Control group
Active

Outcomes
Primary outcome [1] 336201 0
Feasibility and acceptability.
The primary outcomes acceptability and feasibility will be measured using a process evaluation and assessing trial recruitment and retention.
Timepoint [1] 336201 0
Feasibility and acceptability will be assessed pre-intervention (baseline) and post-intervention (6 weeks post-baseline).
Secondary outcome [1] 427301 0
Change in dietary intake.
Timepoint [1] 427301 0
Change in dietary intake will be assessed pre-intervention (baseline) and post intervention phase (6 weeks post-baseline).
Secondary outcome [2] 427304 0
Patient activation.
Timepoint [2] 427304 0
Patient activation will be assessed pre-intervention (baseline) and post intervention phase (6 weeks post-baseline).
Secondary outcome [3] 427305 0
Anthropometric measures.
Timepoint [3] 427305 0
Anthropometry will be assessed at baseline and 6 weeks post-baseline.
Secondary outcome [4] 427306 0
Biochemistry measures.
Timepoint [4] 427306 0
Biochemistry will be assessed at baseline and week 6 post-baseline.
Secondary outcome [5] 427307 0
Glycaemic control.
Timepoint [5] 427307 0
Glycaemic control will be reviewed at baseline, and weeks 2, 4 and 6 post-baseline.
Secondary outcome [6] 427308 0
Quality of life.
Timepoint [6] 427308 0
Quality of life will be measured pre-intervention (baseline) and post-intervention phase (6 weeks post-baseline).
Secondary outcome [7] 427309 0
Acceptability.
Timepoint [7] 427309 0
The process evaluation questionnaire will be completed at week 6 post-baseline.
Secondary outcome [8] 427310 0
Happiness.
Timepoint [8] 427310 0
Happiness will be assessed prior to baseline and at week 6 post-baseline.
Secondary outcome [9] 427311 0
Food security
Timepoint [9] 427311 0
Food security will be assessed prior to baseline and at week 6 post-baseline.
Secondary outcome [10] 427312 0
Malnutrition screening and assessment.
Timepoint [10] 427312 0
Malnutrition screening and assessment will be completed at baseline and week 6 post-baseline..
Secondary outcome [11] 433672 0
Wound healing.
A senior podiatrist at both sites will complete the Wound, Ischemia, and Foot Infection (WIfI) grading and measure the wound using VISITRAK technology (digital planimetry) at baseline, week 2, week 4 and week 6. This will provide a cross-sectional area in cm2. Wound depth will be measured with a probe in mm and wound location will also be documented by the senior podiatrist. The validated WIfI grading scale assesses vascular, infection and wound status. These assessors will be blinded to participant group allocation. Wound healing measurements will be conducted twice to increase reliability of the measurement, and if discrepancies arise, a third measurement will be undergone. Both senior podiatrists have adequate training to complete these assessments and commonly complete these assessments on a daily basis in their clinic practice. A 50% reduction in wound size at 4 weeks is predictive of healing at 12 weeks, and will be considered as part of the primary outcome.
Timepoint [11] 433672 0
Secondary outcome [12] 433673 0
Wound healing.
A senior podiatrist at both sites will complete the Wound, Ischemia, and Foot Infection (WIfI) grading and measure the wound using VISITRAK technology (digital planimetry) at baseline, week 2, week 4 and week 6. This will provide a cross-sectional area in cm2. Wound depth will be measured with a probe in mm and wound location will also be documented by the senior podiatrist. The validated WIfI grading scale assesses vascular, infection and wound status. These assessors will be blinded to participant group allocation. Wound healing measurements will be conducted twice to increase reliability of the measurement, and if discrepancies arise, a third measurement will be undergone. Both senior podiatrists have adequate training to complete these assessments and commonly complete these assessments on a daily basis in their clinic practice. A 50% reduction in wound size at 4 weeks is predictive of healing at 12 weeks, and will be considered as part of the primary outcome.
Timepoint [12] 433673 0
Wound healing will be assessed at baseline, and weeks 2, 4 and 6 post-baseline.

Eligibility
Key inclusion criteria
Inclusion criteria for the study will include:
• individuals aged 18 years and over;
• type 1 or 2 diabetes mellitus, with an active foot ulceration classified VL or L as per WIfI grading;
• previous amputation;
• stage 1 or 2 chronic kidney disease;
• and the ability to provide written informed consent;
• Those on active weekly insulin titration will be included and participants must be willing to attend each visit to the high-risk foot clinic;
• Those taking oral nutrition supplements or vitamin/mineral supplements will be asked to ensure the dose is kept stable and exactly the same for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the study will include:
• foot ulceration classified as M or H as per WIfI;
• current acute osteomyelitis or active Charcot neuroarthropathy;
• malabsorptive background (bariatric surgery and inflammatory bowel disease);
• currently receiving dietetic support/intervention;
• those will food allergies/intolerances;
• history of cognitive disorders impacting their ability to consent or communicate effectively;
• stage 3-5 chronic kidney disease or on dialysis;
• pregnant or breastfeeding;
• In addition, those with a heel wound will be excluded due to the nature of a heel wound being more difficult to manage, worse predicted outcomes and to ensure a homogenous sample for the trial.

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)
The external researcher who conducts sequence generation will conceal the sequence generation and only inform the dietitian conducting the intervention assignment of the intervention once participants have been randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher external to the active intervention will randomise by using a computer-generated block randomisation with a 1:1 ratio. The researcher will enrol participants in the trial and assign participants to their intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be conducted by using StataBE 17 software.
Descriptive statistics will be reported as frequencies and percentages.
Data collected in this trial will be assessed for normality. If the data is normally distributed, we will use parametric tests to present means and SDs. If the data is not normal distributed, we will present medians and IQR’s for descriptive information. Paired t-tests will be utilised to analyse the ARFS, PAM, BMI, weight, and biochemistry.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/02/2024
Actual
19/02/2024
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
12/09/2025
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314907 0
University
Name [1] 314907 0
University of Newcastle
Country [1] 314907 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
School of Health Sciences, College of Health, Medicine and Wellbeing, University of Newcastle, New South Wales, 2308, Australia.
Country
Australia
Secondary sponsor category [1] 316915 0
None
Name [1] 316915 0
Address [1] 316915 0
Country [1] 316915 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313900 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 313900 0
HNE Research Office, Locked Bag 1, New Lambton NSW 2305
Ethics committee country [1] 313900 0
Australia
Date submitted for ethics approval [1] 313900 0
29/09/2023
Approval date [1] 313900 0
15/11/2023
Ethics approval number [1] 313900 0

Summary
Brief summary
Diabetes-related foot ulceration (DFU) affects 56,000 Australians yearly, with one person every hour undergoing a foot/leg amputation. DFU healing is complex and multi-factorial. Our research is focused on diets in DFU healing, which is currently under-researched and highly topical. The research team have added to the literature significantly, demonstrating Australian Adults with DFU have poor quality and variety of dietary intake, have micronutrient deficiencies, and individuals with DFU taking supplementation have significantly increased likelihood of healing. However, we do not currently understand best nutrition intervention to support wound healing in those with diabetes. Therefore, this trail was co-designed with people with DFU and wound clinicians to increase acceptability and feasibility. We propose a a 6-week superiority pilot multicentre, double blinded, parallel-group randomised controlled trial that will determine if a personalised dietary intervention in combination with a food box improves wound healing in those living with a DFU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129722 0
Dr Peta Tehan
Address 129722 0
Department of Surgery, School of Clinical Sciences, Monash University, Melbourne, Victoria, 3168, Australia
Country 129722 0
Australia
Phone 129722 0
+61 2 40164687
Fax 129722 0
Email 129722 0
peta.tehan@monash.edu.au
Contact person for public queries
Name 129723 0
Dr Peta Tehan
Address 129723 0
Department of Surgery, School of Clinical Sciences, Monash University, Melbourne, Australia
Country 129723 0
Australia
Phone 129723 0
+61 2 40164687
Fax 129723 0
Email 129723 0
peta.tehan@monash.edu.au
Contact person for scientific queries
Name 129724 0
Dr Peta Tehan
Address 129724 0
Department of Surgery, School of Clinical Sciences, Monash University, Melbourne, Australia
Country 129724 0
Australia
Phone 129724 0
+61 2 40164687
Fax 129724 0
Email 129724 0
peta.tehan@monash.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.