Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001249842
Ethics application status
Approved
Date submitted
25/07/2021
Date registered
15/09/2021
Date last updated
16/06/2023
Date data sharing statement initially provided
15/09/2021
Date results information initially provided
16/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of smoking on absolute toe pressures in patients with active foot ulcers
Scientific title
The impact of acute and chronic smoking on toe systolic pressures in patients with active foot ulceration
Secondary ID [1] 304869 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 322983 0
Foot ulcers 322984 0
Peripheral arterial disease 322985 0
Condition category
Condition code
Cardiovascular 320554 320554 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Toe systolic pressures will be assessed by a podiatrist on patients attending Blacktown High Risk Foot Service. Patients will be asked when their last cigarette was and measures of toe pressures recorded. We will then ask them not to smoke 12 hours prior to their next appointment (usual treatment time for foot ulcers, 1-2 weeks) and toe pressures will be measured again. This will allow us to assess if there is any difference between toe pressures when a patient has smoked within the last 12 hours or not. We will be able to assess whether this has a direct impact on microcirculation and in turn, healing of foot ulceration
This will all be done during their regular appointments to Blacktown High Risk Foot Service. The appointments are usually of 30-60 minute duration each (depending on the extent of their foot ulceration) and will involve measurement of bilateral toe systolic pressures which takes approximately 5 minutes in total to complete plus a smoking history questionnaire which will also take 5 minutes to complete at the beginning of each appointment. There will need to be two of these appointments for the purpose of the study, although all their usual care is provided during this time.
Participants will be monitored for 2 years post-enrolment for any changes in ulcers, arterial disease or lower limb amputations. This data will be collected from medical records without active participation required.
Intervention code [1] 321260 0
Early Detection / Screening
Intervention code [2] 321499 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328378 0
Toe pressure measured using a a digital pneumatic cuff and a photoplethysmograph
Timepoint [1] 328378 0
Baseline then 1-2 weeks post enrolment
Primary outcome [2] 328379 0
Time to 50% ulcer healing as assessed by continued patient care and accessing patient medical records
Timepoint [2] 328379 0
2 years post enrolment
Secondary outcome [1] 398799 0
Infection rates assessed by accessing patient medical records
Timepoint [1] 398799 0
2 years post enrolment
Secondary outcome [2] 398800 0
Amputation rates assessed by accessing patient medical records
Timepoint [2] 398800 0
2 years post enrolment
Secondary outcome [3] 399962 0
Time to 100% ulcer healing assessed by accessing patient medical records
Timepoint [3] 399962 0
2 years post enrolment

Eligibility
Key inclusion criteria
Between the ages of 30 and 85 years of age inclusive
Current or past tobacco smoker, past smoker defined as having stopped smoking > 1 year ago
Active foot ulceration
Minimum age
30 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled dyslipidemia
Coronary heart disease or history of myocardial infarction
History of lower extremity bypass
History of stroke or transient ischeamic attack (TIA)
Unwilling/unable to participate or to sign the consent form

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/05/2022
Actual
16/05/2022
Date of last participant enrolment
Anticipated
Actual
10/04/2023
Date of last data collection
Anticipated
Actual
10/04/2023
Sample size
Target
100
Accrual to date
Final
195
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20075 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 34783 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 309244 0
Hospital
Name [1] 309244 0
Blacktown Hospital
Country [1] 309244 0
Australia
Primary sponsor type
Hospital
Name
Blacktown Hospital
Address
18 Blacktown Road, Blacktown, NSW 2148
Country
Australia
Secondary sponsor category [1] 310213 0
University
Name [1] 310213 0
University of Sydney
Address [1] 310213 0
Camperdown, NSW 2006
Country [1] 310213 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309090 0
WSLHD Human Research Ethics Committee
Ethics committee address [1] 309090 0
Research & Education Network building
Westmead Hospital, Westmead
NSW 2145
Ethics committee country [1] 309090 0
Australia
Date submitted for ethics approval [1] 309090 0
01/11/2021
Approval date [1] 309090 0
12/05/2022
Ethics approval number [1] 309090 0

Summary
Brief summary
Toe pressures will be measured at the patients initial visit at Blacktown High Risk Foot Service and will then be asked if they are able to cease smoking for 12 hours prior to their next appointment, and toe pressures measured again. Factors such as smoking history, cigarettes per day, years smoking, and other medical history will be taken. At the end of the study period, this will allow us to assess the direct affect of acute smoking on toe pressures.
Trial website
Trial related presentations / publications
Public notes
Ethics approval is not planned to be obtained prior to enrolment of first participant as we are not completing anything outside of usual care for participants attending the High Risk Foot Service. Absolute toe pressures are non invasive and are routinely completed during regular appointments with our service.

Contacts
Principal investigator
Name 112938 0
Ms Nada Bechara
Address 112938 0
Blacktown Hospital
18 Blacktown Road, Blacktown, NSW 2148
Country 112938 0
Australia
Phone 112938 0
+61 02 9881 8393
Fax 112938 0
Email 112938 0
[email protected]
Contact person for public queries
Name 112939 0
Ms Nada Bechara
Address 112939 0
Blacktown Hospital
18 Blacktown Road, Blacktown, NSW 2148
Country 112939 0
Australia
Phone 112939 0
+61 02 9881 8393
Fax 112939 0
Email 112939 0
[email protected]
Contact person for scientific queries
Name 112940 0
Prof Jenny Gunton
Address 112940 0
University of Sydney
Camperdown, NSW 2006
Country 112940 0
Australia
Phone 112940 0
+61 02 8890 8089
Fax 112940 0
Email 112940 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


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.