Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001142325
Ethics application status
Approved
Date submitted
14/06/2017
Date registered
4/08/2017
Date last updated
1/10/2019
Date data sharing statement initially provided
1/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin C and healing of foot ulcers
Scientific title
Vitamin C and healing of foot ulcers in people attending high risk foot clinic
Secondary ID [1] 292193 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot ulcer 303670 0
Condition category
Condition code
Skin 303053 303053 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, controlled trial of supplementation with vitamin C versus glucosamine (the 'placebo') for healing of foot ulcers.
Daily, oral capsule, 500mg of vitamin C, up to 60 days. Empty packet return will be used to assess compliance. In people in whom baseline levels are low, from the return of the result, they will receive BOTH supplements (so the first part of the study remains blinded).
Intervention code [1] 298349 0
Treatment: Other
Comparator / control treatment
Vitamin C daily or glucosamine daily.
When vitamin C results are available, if deficient, people will receive BOTH treatments, so that they remain blinded to initial treatment.
Glucosamine, capsule orally, daily, 1000mg.
Control group
Placebo

Outcomes
Primary outcome [1] 302429 0
Ulcer healing at 8 weeks (% reduction compared to initial ulcer). Wound will be traced on plastic and area measured by an investigator blinded to treatment assignment.
Timepoint [1] 302429 0
8 weeks
Secondary outcome [1] 335961 0
Time to ulcer healing (no remaining ulcer) by visual examination by the treating clinician.
Timepoint [1] 335961 0
At each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Secondary outcome [2] 335962 0
Time to 50% ulcer healing. Wound will be traced on plastic and area measured by an investigator blinded to treatment assignment.
Timepoint [2] 335962 0
At each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Secondary outcome [3] 335963 0
Time to complete ulcer healing in people with vitamin C deficiency at baseline by visual examination by the treating clinician.
Timepoint [3] 335963 0
8 weeks
Secondary outcome [4] 335964 0
Time to complete ulcer healing (visual examination by treating clinician) in people with baseline vitamin C deficiency

This is an analysis of just people with baseline C deficiency, who will be a subset of the whole group.
Timepoint [4] 335964 0
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Secondary outcome [5] 335965 0
Time to 50% ulcer healing in people with baseline vitamin C deficiency

This is an analysis of just people with baseline C deficiency, who will be a subset of the whole group.
Timepoint [5] 335965 0
Time to 50% ulcer healing. Wound will be traced on plastic and area measured by an investigator blinded to treatment assignment at each visit.

Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Secondary outcome [6] 335966 0
Ulcers will be traced on plastic as above at baseline, and decrease in area will be examined. Time to 50% ulcer healing in people without vitamin C deficiency at baseline

This is an analysis of just people without baseline C suffficiency, who will be a subset of the whole group.
Timepoint [6] 335966 0
8 weeks
Secondary outcome [7] 335968 0
Time to 50% ulcer healing in people without vitamin C deficiency at baseline

This is an analysis of just people without baseline C suffficiency, who will be a subset of the whole group.
Timepoint [7] 335968 0
Time to 50% ulcer healing. Wound will be traced on plastic and area measured by an investigator blinded to treatment assignment at each clinic visit.
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Secondary outcome [8] 335969 0
Time to complete ulcer healing (visual inspection by treating clinician) in people with vascular disease (determined by clinical measures and ultrasound measured ankle-brachial index)
Timepoint [8] 335969 0
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Secondary outcome [9] 335970 0
Time to complete ulcer healing in people without vascular disease (determined by clinical measures and ultrasound measured ankle-brachial index)

Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Timepoint [9] 335970 0
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Secondary outcome [10] 335971 0
Time to 50% ulcer healing in people with vascular disease (determined by clinical measures and ultrasound measured ankle-brachial index)

Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Timepoint [10] 335971 0
Time to 50% ulcer healing. Wound will be traced on plastic and area measured by an investigator blinded to treatment assignment at each visit..

Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Secondary outcome [11] 335972 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 [11] 335972 0
8 weeks
Secondary outcome [12] 335973 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 [12] 335973 0
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs
Secondary outcome [13] 335974 0
Time to 50% ulcer healing in people with diabetes

A pre-specified subgroup for outcome.
Timepoint [13] 335974 0
Time to 50% ulcer healing. Wound will be traced on plastic and area measured by an investigator blinded to treatment assignment at each clinic visit.
Ulcers will be assessed at each clinic visit; baseline and usually weekly for at least 3 weeks then fortnightly until ulcer healing occurs

Eligibility
Key inclusion criteria
New presentation to high-risk foot clinic at Westmead 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.
Bilateral below knee amputations.
Inability to give informed consent.
Unable to take vitamin C / glucosamine 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 phone / computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a table created by 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
Other design features
People randomised to either vitamin C or glucosamine at commencement. Once serum vitamin C results are available (usually 3-5 weeks), people who are deficient in vitamin C will receive BOTH treatments so that all people who are deficient will receive treatment.
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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Interrim analysis significant
Date of first participant enrolment
Anticipated
28/08/2017
Actual
4/09/2017
Date of last participant enrolment
Anticipated
Actual
3/01/2019
Date of last data collection
Anticipated
1/10/2019
Actual
Sample size
Target
200
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8350 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 16421 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 296730 0
Hospital
Name [1] 296730 0
Research and Education Network, Westmead Hospital
Country [1] 296730 0
Australia
Primary sponsor type
Hospital
Name
Research and Education Network, Westmead Hospital
Address
Westmead Hospital
Cnr Darcy and Hawkesbury Rds,
Westmead. NSW. 2145
Country
Australia
Secondary sponsor category [1] 295701 0
None
Name [1] 295701 0
Address [1] 295701 0
Country [1] 295701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297958 0
Westmead Human resaerch ethics committee
Ethics committee address [1] 297958 0
Ethics committee country [1] 297958 0
Australia
Date submitted for ethics approval [1] 297958 0
03/04/2017
Approval date [1] 297958 0
13/06/2017
Ethics approval number [1] 297958 0
5127 HREC/17/WMEAD/183

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75578 0
Prof Jenny Gunton
Address 75578 0
Room 2040, Level 2,
Westmead hospital.
Westmead. NSW. 2145
Country 75578 0
Australia
Phone 75578 0
+61 2 8890 8089
Fax 75578 0
Email 75578 0
[email protected]
Contact person for public queries
Name 75579 0
Jenny Gunton
Address 75579 0
Room 2040, Level 2,
Westmead hospital.
Westmead. NSW. 2145
Country 75579 0
Australia
Phone 75579 0
+61 2 8890 8089
Fax 75579 0
Email 75579 0
[email protected]
Contact person for scientific queries
Name 75580 0
Jenny Gunton
Address 75580 0
Room 2040, Level 2,
Westmead hospital.
Westmead. NSW. 2145
Country 75580 0
Australia
Phone 75580 0
+61 2 8890 8089
Fax 75580 0
Email 75580 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
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
SourceTitleYear of PublicationDOI
Dimensions AIWound healing with “spray-on” autologous skin grafting (ReCell) compared with standard care in patients with large diabetes-related foot wounds: an open-label randomised controlled trial2021https://doi.org/10.1111/iwj.13646
N.B. These documents automatically identified may not have been verified by the study sponsor.