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Trial registered on ANZCTR


Registration number
ACTRN12621001493831
Ethics application status
Approved
Date submitted
22/09/2021
Date registered
2/11/2021
Date last updated
2/11/2021
Date data sharing statement initially provided
2/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
VITAFOOT- a pilot randomised controlled trial of vitamin supplementation on wound healing in people with diabetes-related foot ulcers
Scientific title
VITAFOOT- a pilot randomised controlled trial of vitamin supplementation on wound healing in people with diabetes-related foot ulcers
Secondary ID [1] 305385 0
Nil
Universal Trial Number (UTN)
Trial acronym
VITAFOOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes-related foot disease 323739 0
Condition category
Condition code
Metabolic and Endocrine 321266 321266 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects allocated to the intervention arm will be administered oral capsules with Vitamin C 1000mg, Zinc picolinate 25mg and Vitamin A 750mcg/2500IU daily for 28 days. Adherence will be monitored with a count of returned capsules at 28 days.
Intervention code [1] 321793 0
Treatment: Drugs
Comparator / control treatment
Subjects allocated to the placebo arm will be administered placebo capsules containing an inactive comparator, daily for 28 days. Placebo medication will be a commercial placebo from Optima Ovest, Perth, Western Australia
Control group
Placebo

Outcomes
Primary outcome [1] 329047 0
Percentage change in wound area measured by Silhouette from baseline to 12 weeks.
Timepoint [1] 329047 0
12 weeks from initiating treatment
Secondary outcome [1] 401262 0
Proportion of completely healed DFUs at 12 weeks by clinical assessment
Timepoint [1] 401262 0
12 weeks from initiating treatment
Secondary outcome [2] 401263 0
A composite outcome of any of the following: minor limb amputation, major limb amputation or death within 12 weeks from clinical assessment and audit of hospital records
Timepoint [2] 401263 0
12 weeks from initiating treatment

Eligibility
Key inclusion criteria
i) Age greater than or equal to 18years
ii) Diabetes (type 1 or 2) defined according to international consensus guidelines
iii) Admission to Fiona Stanley Hospital under the inpatient MDFU service or attending outpatient MDFU clinic with a DFU
iv) Ulcer present for at least 4 weeks
v) Competent and willing to provide informed consent
vi) Able and willing to be followed up at 4 and 12 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Not competent to provide informed consent i.e. cognitive impairment, significant psychiatric illness, non-english speaking or other
ii) Women of reproductive age i.e. less than 45 years
iii) Already on VitC, VitA and/or zinc supplements or taken within 4 weeks of enrolment
iv) Known VitC, VitA and/or zinc deficiencies
v) Unlikely to be accessible for follow-up visit over the next 12 weeks

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)
Randomisation of study supplements will be conducted by the Clinical Trials Pharmacist at Fiona Stanley Hospital. The randomisation schedule will be prepared using SealedEnvelope.com. This list will be provided to the manufacturer (off site) in order to create blinded, subject specific kits. Study supplements and placebo will be identical in appearance and non-identifiable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation in variable block sizes will be conducted by the Fiona Stanley Hospital Clinical Trials Pharmacist and both participants and study investigators will be blinded to the intervention. The randomisation schedule will be prepared using SealedEnvelope.com. This list will be provided to the manufacturer in order to create blinded, subject specific kits.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/11/2021
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20572 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 35356 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 309751 0
Other Collaborative groups
Name [1] 309751 0
'National Health and Medical Research Council (MRFF Investigator Grant held by Laurens Manning)
Country [1] 309751 0
Australia
Primary sponsor type
Hospital
Name
South Metropolitan Health Service - FSHFH Hospital Group
Address
Fiona Stanley Hospital, Murdoch Drive, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 310959 0
None
Name [1] 310959 0
Address [1] 310959 0
Country [1] 310959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309507 0
South Metropolitan Health Service Human Research Ethics Committee (EC00265)
Ethics committee address [1] 309507 0
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150
Ethics committee country [1] 309507 0
Australia
Date submitted for ethics approval [1] 309507 0
Approval date [1] 309507 0
14/06/2021
Ethics approval number [1] 309507 0

Summary
Brief summary
Diabetes-related foot ulcers (DFU) are a common and burdensome condition. Established interventions to promote DFU healing include local wound care, debridement, pressure offloading, management of infection and revascularisation. Despite this, the condition still accounts for significant morbidity and mortality in the community and further improvements in ulcer healing and overall outcomes in patients is essential. Recent studies have suggested that patients with type 2 diabetes mellitus are at risk of nutritional deficiencies due to high calorie yet low quality diets, poor food choices and/or restrictive eating (2). Nutrients such as Vitamin C (VitC), Vitamin A (VitA) and zinc are essential in wound healing by stimulating epithelialisation and cellular proliferation. Deficiencies in these micronutrients are common amongst people with diabetes and DFU but data regarding the effect of supplementation is limited .

In this pilot randomised controlled trial, we aim to recruit 100 adult patients at Fiona Stanley Hospital or Fremantle Hospital with a DFU present for >4 weeks, without healing. Subjects can be either hospitalised under the inpatient Multidisciplinary Diabetes Foot Ulcer (MDFU) service or attending the outpatient MDFU clinic. We will then compare 28 days of oral supplementation of VitC, VitA and zinc with placebo in a pilot randomised controlled trial. Subjects will be followed up at 4 and 12 weeks to assess wound healing, as measured using ARANZ Medical Silhouette™ wound measurement camera. Our primary outcome is to prove that micronutrient supplementation with VitC, VitA and zinc will result in greater reduction in wound area from baseline to 12 weeks (ie percentage change in wound area measured by Silhouette wound camera at 12 weeks). Secondary outcomes include: i) the percentage of completely healed DFUs at 12 weeks (ie percentage of patients with completely healed DFU at 12 weeks in intervention vs control group) ii) minor or major lower limb amputation or death at 12 weeks and iii) wound healing trajectory over 12 weeks (measured using total % area change from baseline).

The following are not prespecified secondary outcomes but will also be reported i) baseline prevalence of VitC, VitA and zinc deficiencies in people with DFU, ii) VitC, VitA and zinc levels after 28 days of supplementation iii) adverse effects associated with micronutrient supplementation and placebo iv) baseline prevalence of anaemia, absolute iron deficiency and functional iron deficiency.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114398 0
Dr Emma Hamilton
Address 114398 0
Dr Emma Hamilton
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH Western Australia 6150
Country 114398 0
Australia
Phone 114398 0
+61 8 61526041
Fax 114398 0
Email 114398 0
[email protected]
Contact person for public queries
Name 114399 0
Dr Emma Hamilton
Address 114399 0
Dr Emma Hamilton
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH Western Australia 6150
Country 114399 0
Australia
Phone 114399 0
+61 8 61526041
Fax 114399 0
Email 114399 0
[email protected]
Contact person for scientific queries
Name 114400 0
Dr Emma Hamilton
Address 114400 0
Dr Emma Hamilton
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH Western Australia 6150
Country 114400 0
Australia
Phone 114400 0
+61 8 61526041
Fax 114400 0
Email 114400 0
[email protected]

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.