ANZCTR - Registration

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:00pm (AEST) on Thursday 10th of April for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12623000435684

Ethics application status

Approved

Date submitted

17/04/2023

Date registered

28/04/2023

Date last updated

15/09/2024

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]

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

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Percentage change in wound area measured by Silhouette from baseline to 12 weeks.

Timepoint [1]

12 weeks from initiating treatment

Secondary outcome [1]

Proportion of completely healed DFUs at 12 weeks by clinical assessment.

Timepoint [1]

At conclusion of study

Secondary outcome [2]

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]

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?

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

30/04/2025

Actual

Date of last data collection

Anticipated

30/01/2025

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [2]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [3]

Royal Perth Hospital - Perth

Recruitment hospital [4]

Albany Hospital - Albany

Recruitment postcode(s) [1]

6150 - Murdoch

Recruitment postcode(s) [2]

6009 - Nedlands

Recruitment postcode(s) [3]

6000 - Perth

Recruitment postcode(s) [4]

6330 - Albany

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (MRFF Investigator Grant held by Laurens Manning)

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service Human Research Ethics Committee (EC00265)

Ethics committee address [1]

Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/02/2023

Ethics approval number [1]

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

A/Prof Laurens Manning

Address

Fiona Stanley Hospital 11 Robin Warren Drive MURDOCH Western Australia 6150 Australia

Country

Australia

Phone

+61 8 6151 1156

Fax

[email protected]

Contact person for public queries

Name

Alana Di Giacomo

Address

Alana Di Giacomo Fiona Stanley Hospital 11 Robin Warren Drive MURDOCH Western Australia 6150

Country

Australia

Phone

+61 8 6151 1145

Fax

[email protected]

Contact person for scientific queries

Name

Laurens Manning

Address

Fiona Stanley Hospital 11 Robin Warren Drive MURDOCH Western Australia 6150 Australia

Country

Australia

Phone

+61 8 6151 1156

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No 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.	Type	Citation	Link	Email	Other Details	Attachment
18909	Study protocol			[email protected]		Study-related document.doc

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.

Trial Review

Documents added manually

Documents added automatically