Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001274763
Ethics application status
Approved
Date submitted
21/09/2022
Date registered
28/09/2022
Date last updated
16/06/2023
Date data sharing statement initially provided
28/09/2022
Date results information initially provided
16/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin blood levels and severity of foot ulceration
Scientific title
Vitamin C, D and zinc levels and the link to severity of foot ulceration
Secondary ID [1] 307984 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot ulcer 327696 0
Condition category
Condition code
Skin 324776 324776 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients are sent for routine blood tests as part of usual care at Blacktown High Risk Foot Service once off at their initial visit. These blood tests include vitamin C, D and zinc. As part of each visit, ulcer size is measured using a Silhouette Star ulcer camera (ARANZ medical) by a registered podiatrist which takes 30 minutes to complete the full assessment. These visits are 1-4 weeks apart depending on participants needs and the overall duration of observation is 12 months post enrolment. We will be correlating blood levels with ulcer size for any significances.
Intervention code [1] 324473 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332601 0
Baseline vitamin C levels completed via blood tests
Timepoint [1] 332601 0
Assessed once only at the time of enrolment
Primary outcome [2] 332602 0
Baseline vitamin D levels via blood tests
Timepoint [2] 332602 0
Assessed once only at the time of enrolment
Primary outcome [3] 332603 0
Baseline zinc levels via blood tests
Timepoint [3] 332603 0
Assessed once only at the time of enrolment
Secondary outcome [1] 414027 0
Ulcer size as measured by Silhouette Star camera (ARANZ medical)
Timepoint [1] 414027 0
Ulcer size as measured by Silhouette Star camera (ARANZ medical) at each visit from enrolment for up to 12 months post enrolment

Eligibility
Key inclusion criteria
Over the age of 18 years old
Active foot ulceration
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to have a blood test

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/10/2022
Actual
7/11/2022
Date of last participant enrolment
Anticipated
Actual
7/04/2023
Date of last data collection
Anticipated
Actual
29/05/2023
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23180 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 38545 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 312250 0
Hospital
Name [1] 312250 0
Blacktown Hospital
Country [1] 312250 0
Australia
Primary sponsor type
Hospital
Name
Blacktown Hospital
Address
18 Blacktown Road, Blacktown NSW 2148
Country
Australia
Secondary sponsor category [1] 313788 0
University
Name [1] 313788 0
University of Sydney
Address [1] 313788 0
Camperdown, NSW 2006
Country [1] 313788 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311625 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 311625 0
WSLHD Research and Education Network,
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145
Ethics committee country [1] 311625 0
Australia
Date submitted for ethics approval [1] 311625 0
03/10/2022
Approval date [1] 311625 0
17/10/2022
Ethics approval number [1] 311625 0

Summary
Brief summary
We are aiming to assess whether there are any correlations between serum levels of vitamin C, vitamin D or zinc in relation to foot ulceration. Patients will be recruited from Blacktown high risk foot service and blood tests are completed as part of routine care. Ulcer sizes are measured at each visit which is anywhere between 1-4 weeks apart. The ulcer size is measured using a Silhouette Star camera (ARANZ medical) and will be correlated to their serum blood levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121766 0
Miss Nada Bechara
Address 121766 0
Blacktown Hospital 18 Blacktown Road, Blacktown, NSW 2148
Country 121766 0
Australia
Phone 121766 0
+61 02 9881 8393
Fax 121766 0
Email 121766 0
nada.bechara@health.nsw.gov.au
Contact person for public queries
Name 121767 0
Miss Nada Bechara
Address 121767 0
Blacktown Hospital 18 Blacktown Road, Blacktown, NSW 2148
Country 121767 0
Australia
Phone 121767 0
+61 02 98818393
Fax 121767 0
Email 121767 0
nada.bechara@health.nsw.gov.au
Contact person for scientific queries
Name 121768 0
Prof Jenny Gunton
Address 121768 0
University of Sydney Camperdown, NSW 2006
Country 121768 0
Australia
Phone 121768 0
+61 02 8890 8089
Fax 121768 0
Email 121768 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


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.