Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
ACTRN12622001144707
Ethics application status
Approved
Date submitted
16/08/2022
Date registered
22/08/2022
Date last updated
12/07/2023
Date data sharing statement initially provided
22/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin C and zinc for healing of foot ulcers
Scientific title
Vitamin C and zinc for healing of foot ulcers in people attending a high risk foot service
Secondary ID [1] 307787 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot ulcer 327365 0
Condition category
Condition code
Skin 324489 324489 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2x2 factorial design randomised, double blinded controlled trial of supplementation with vitamin C and/or zinc vs placebo for healing of foot ulcers in patients attending a high risk foot service
Daily, oral capsule, 500mg of vitamin C and/or 30mg of zinc for 60 days. Empty packet will be returned to treating team and will be used to assess compliance. In people in whom baseline levels are low for either vit C or zinc, from the return of the blood test result of vitamin C and zinc (returned at 4 weeks), they will receive BOTH supplements (so the first 4 weeks of the study remains blinded)
Intervention code [1] 324249 0
Treatment: Other
Comparator / control treatment
Vitamin C daily, and/or zinc daily, and/or placebo daily
When vitamin C and zinc results are available at 4 weeks, if deficient, people will receive BOTH treatments, so that they remain blinded to initial treatment
Placebo is microcrystalline cellulose
Control group
Placebo

Outcomes
Primary outcome [1] 332311 0
Ulcer healing at 8 weeks (% reduction compared to initial ulcer). Wound image will be captured and measured using Silhouette Star wound camera (ARANZ medical).
Timepoint [1] 332311 0
8 weeks after starting supplement intake
Secondary outcome [1] 412974 0
Time to ulcer healing (no remaining ulcer) by visual examination by the treating clinician
Timepoint [1] 412974 0
At each clinic visit; baseline and usually weekly for at least 4 weeks after starting supplement intake then fortnightly until ulcer healing occurs
Secondary outcome [2] 412975 0
Time to 50% ulcer healing. Wound image will be captured and measured using Silhouette Star wound camera (ARANZ medical).
Timepoint [2] 412975 0
At each clinic visit; baseline and usually weekly for at least 4 weeks after starting supplement intake then fortnightly until ulcer healing occurs
Secondary outcome [3] 412976 0
Time to complete ulcer healing in people with vitamin C deficiency at baseline by visual examination by the treating clinician.
Timepoint [3] 412976 0
8 weeks after starting supplement intake
Secondary outcome [4] 412977 0
Time to 50% ulcer healing in people with baseline vitamin C deficiency as measured by wound image captured and measured using Silhouette Star wound camera (ARANZ medical)
This is an analysis of just people with baseline C deficiency, who will be a subset of the whole group
Timepoint [4] 412977 0
Time to 50% ulcer healing measured using Silhouette Star wound camera (ARANZ medical)
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 4 weeks following supplementation then fortnightly until ulcer healing occurs
Secondary outcome [5] 412978 0
Time to 50% ulcer healing in people without vitamin C deficiency at baseline measured using Silhouette Star wound camera (ARANZ medical)

This is an analysis of just people without baseline C suffficiency, who will be a subset of the whole group
Timepoint [5] 412978 0
Time to 50% ulcer healing measured using Silhouette Star wound camera (ARANZ medical)
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 4 weeks following supplementation then fortnightly until ulcer healing occurs
Secondary outcome [6] 412979 0
Time to 50% ulcer healing in people with baseline zinc deficiency measured using Silhouette Star wound camera (ARANZ medical)
Timepoint [6] 412979 0
Time to 50% ulcer healing measured using Silhouette Star wound camera (ARANZ medical)
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 4 weeks following supplementation then fortnightly until ulcer healing occurs
Secondary outcome [7] 412980 0
Time to complete ulcer healing in people with zinc deficiency at baseline by visual examination by the treating clinician.
Timepoint [7] 412980 0
8 weeks after starting supplement intake
Secondary outcome [8] 412981 0
Time to complete ulcer healing (visual inspection by treating clinician) in people with vascular disease (determined by clinical measures and absolute toe pressure measurements)
Timepoint [8] 412981 0
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 4 weeks
after starting supplement intake then fortnightly until ulcer healing occurs
Secondary outcome [9] 412982 0
Time to complete ulcer healing in people without vascular disease (determined by clinical measures and absolute toe pressure measurements)
Timepoint [9] 412982 0
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 4 weeks after starting supplement intake then fortnightly until ulcer healing occurs
Secondary outcome [10] 412983 0
Time to complete ulcer healing (visual inspection by treating clinician) in people with diabetes assessed by a clinician at each visit.
A pre-specified subgroup for outcome.
Timepoint [10] 412983 0
8 weeks after starting supplement intake
Secondary outcome [11] 412984 0
Time to 50% ulcer healing in people with diabetes, wound image will be captured using Silhouette wound camera (ARANZ medical) and measured.
Timepoint [11] 412984 0
Time to 50% ulcer healing
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 4 weeks after starting supplement intake then fortnightly until ulcer healing occurs

Eligibility
Key inclusion criteria
New presentation to the high risk foot service at Blacktown Hospital. Only people with a foot ulcer can attend this clinic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not a new patient for the clinic
Inability to give informed consent
Taking vitamin C or zinc supplements within 3 months
Unable to take vitamin C /zinc tablets

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software
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
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Alpha 0.05, power 90%
50% improvement in ulcer healing at 8 weeks, recruiting for at least 1 year, followup for up to 1 year as needed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/09/2022
Actual
9/12/2022
Date of last participant enrolment
Anticipated
15/07/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22978 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 25169 0
Westmead Hospital - Westmead
Recruitment hospital [3] 25170 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 40838 0
2065 - St Leonards
Recruitment postcode(s) [2] 40837 0
2145 - Westmead
Recruitment postcode(s) [3] 38286 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 312057 0
Hospital
Name [1] 312057 0
Blacktown Hospital
Country [1] 312057 0
Australia
Funding source category [2] 312058 0
Hospital
Name [2] 312058 0
Westmead Charitable Trust
Country [2] 312058 0
Australia
Funding source category [3] 314273 0
Hospital
Name [3] 314273 0
Research and Education Network
Country [3] 314273 0
Australia
Primary sponsor type
Hospital
Name
Blacktown Hospital
Address
18 Blacktown Road, Blacktown NSW 2148
Country
Australia
Secondary sponsor category [1] 313562 0
University
Name [1] 313562 0
University of Sydney
Address [1] 313562 0
Camperdown NSW
Country [1] 313562 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311467 0
WSLHD Human Research Ethics Committee
Ethics committee address [1] 311467 0
Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Ethics committee country [1] 311467 0
Australia
Date submitted for ethics approval [1] 311467 0
27/07/2021
Approval date [1] 311467 0
06/01/2022
Ethics approval number [1] 311467 0
2021/PID02219

Summary
Brief summary
The aim is to perform a randomised, double-blind, inactive-comparator-controlled trial of vitamin C and zinc for the treatment of foot ulcers in people attending multi-disciplinary high-risk foot ulcer clinics. Our overall hypothesis is that treating people who have chronic foot ulcers with vitamin C and/or zinc will improve ulcer healing and thereby improve quality of life, prevent osteomyelitis, decrease amputations and will be safe, highly cost-effective and widely implementable.
Patients will be treated for 8 weeks and followed up until complete ulcer healing, amputation, or a minimum of 12 weeks if not fully healed before. Patients will have a blood test for serum vitamin C and zinc at baseline, accompanied by any usual tests required by the foot ulcer clinics.
After this baseline visit, patients will otherwise have usual care at the foot ulcer clinic, except for taking their assigned tablets.
After 4 weeks their blood results for zinc and vitamin C will be made available. If deficient, they will receive both tablets for their deficiency. This will ensure we offer all people who are identified as deficient treatment but maintain blinding to their original 4 weeks of treatment.
At 8 weeks or the closest visit, people will have their blood vitamin C and zinc re-tested. They will then be followed until complete ulcer healing, amputation or a minimum of 12 weeks if not healed before.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121198 0
Ms Nada Bechara
Address 121198 0
High Risk Foot Service
Blacktown Hospital
18 Blacktown Road, Blacktown NSW 2145
Country 121198 0
Australia
Phone 121198 0
+61 2 98818393
Fax 121198 0
Email 121198 0
nada.bechara@health.nsw.gov.au
Contact person for public queries
Name 121199 0
Prof Jenny Gunton
Address 121199 0
Chair of Medicine
Westmead Hospital
Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 121199 0
Australia
Phone 121199 0
+61 2 8890 5555
Fax 121199 0
Email 121199 0
jenny.gunton@sydney.edu.au
Contact person for scientific queries
Name 121200 0
Prof Jenny Gunton
Address 121200 0
Chair of Medicine
Westmead Hospital
Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 121200 0
Australia
Phone 121200 0
+61 2 8890 5555
Fax 121200 0
Email 121200 0
jenny.gunton@sydney.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
Not required when trial registered.


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.