Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000435684
Ethics application status
Approved
Date submitted
17/04/2023
Date registered
28/04/2023
Date last updated
4/10/2023
Date data sharing statement initially provided
28/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
VITA-AMP - a pilot randomised controlled trial of vitamin supplementation in people following diabetes-related minor amputation of the lower limb.
Scientific title
VITA-AMP - a pilot randomised controlled trial of the effect of vitamin supplementation on wound area in people following diabetes-related minor amputation of the lower limb.
Secondary ID [1] 309376 0
NIL
Universal Trial Number (UTN)
Trial acronym
VITA-AMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes-related foot disease 329594 0
Condition category
Condition code
Metabolic and Endocrine 326520 326520 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 and Zinc picolinate 25mg daily for 28 days. Adherence will be monitored with a count of returned capsules at 28 days.
Intervention code [1] 325809 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] 334364 0
Percentage change in wound area measured by Silhouette from baseline to 12 weeks.
Timepoint [1] 334364 0
12 weeks from initiating treatment
Secondary outcome [1] 420397 0
Proportion of completely healed DFUs at 12 weeks by clinical assessment.
Timepoint [1] 420397 0
At conclusion of study
Secondary outcome [2] 420398 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] 420398 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, Royal Perth Hospital, Sir Charles Gairdner Hospital or Albany Hospital under the inpatient high-risk foot team service or attending outpatient clinic with a DFU.
iv) Current inpatient admission or outpatient within 7 days of a minor amputation or debridement
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 and/or zinc supplements or taken within 4 weeks of enrolment
iv) Known VitC 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
Recruiting
Date of first participant enrolment
Anticipated
27/09/2023
Actual
27/09/2023
Date of last participant enrolment
Anticipated
27/09/2024
Actual
Date of last data collection
Anticipated
27/12/2024
Actual
Sample size
Target
100
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24463 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 24464 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 24465 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 24466 0
Albany Hospital - Albany
Recruitment postcode(s) [1] 40048 0
6000 - Perth
Recruitment postcode(s) [2] 40047 0
6009 - Nedlands
Recruitment postcode(s) [3] 40046 0
6150 - Murdoch
Recruitment postcode(s) [4] 40049 0
6330 - Albany

Funding & Sponsors
Funding source category [1] 313571 0
Government body
Name [1] 313571 0
National Health and Medical Research Council (MRFF Investigator Grant held by Laurens Manning)
Country [1] 313571 0
Australia
Primary sponsor type
Hospital
Name
South Metropolitan Health Service - Fiona Stanley Fremantle Hospitals Group
Address
Fiona Stanley Hospital, Murdoch Drive, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 315355 0
None
Name [1] 315355 0
Address [1] 315355 0
Country [1] 315355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312752 0
South Metropolitan Health Service Human Research Ethics Committee (EC00265)
Ethics committee address [1] 312752 0
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150
Ethics committee country [1] 312752 0
Australia
Date submitted for ethics approval [1] 312752 0
Approval date [1] 312752 0
27/02/2023
Ethics approval number [1] 312752 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.

Our team is currently recruiting to a double-blinded randomised controlled trial of multivitamins in patients with chronic foot ulcers (VITAFOOT). However following minor amputations, patients are ineligible for recruitment for VITAFOOT, yet presumably are also at similar risk of micronutrient deficiencies.

To complement VITAFOOT, in this pilot randomised controlled trial, we aim to recruit 100 adult patients at Fiona Stanley, Royal Perth, Sir Charles Gairdner or Albany Hospital with a DFU within 7 days of a minor amputation or debridement. Subjects can be either hospitalised or attending the outpatient high risk foot clinic. We will then compare 28 days of oral supplementation of VitC 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 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 and zinc deficiencies in people with DFU, ii) 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 125778 0
A/Prof Laurens Manning
Address 125778 0
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH Western Australia 6150
Australia
Country 125778 0
Australia
Phone 125778 0
+61 8 6151 1156
Fax 125778 0
Email 125778 0
laurens.manning@uwa.edu.au
Contact person for public queries
Name 125779 0
Miss Alana Di Giacomo
Address 125779 0
Alana Di Giacomo
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH Western Australia 6150
Country 125779 0
Australia
Phone 125779 0
+61 8 6151 1145
Fax 125779 0
Email 125779 0
alana.digiacomo@uwa.edu.au
Contact person for scientific queries
Name 125780 0
A/Prof Laurens Manning
Address 125780 0
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH Western Australia 6150
Australia
Country 125780 0
Australia
Phone 125780 0
+61 8 6151 1156
Fax 125780 0
Email 125780 0
laurens.manning@uwa.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
No informed consent to share data.
Maintaining patient confidentiality: As this study is small, the data (relating to age and amputation) may be re-identifiable by participants or other interested parties.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18909Study protocol  alana.digiacomo@uwa.edu.au 385680-(Uploaded-24-07-2023-13-04-37)-Study-related document.doc



Results publications and other study-related documents

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