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Trial registered on ANZCTR


Registration number
ACTRN12618000236291
Ethics application status
Approved
Date submitted
30/01/2018
Date registered
14/02/2018
Date last updated
28/05/2019
Date data sharing statement initially provided
28/05/2019
Date results information initially provided
28/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Wound healing in patients with venous leg ulcer: A prospective, multicentre observational cohort study.
Scientific title
Wound healing in patients with venous leg ulcer: A prospective, multicentre observational cohort study.
Secondary ID [1] 293848 0
None
Universal Trial Number (UTN)
Trial acronym
ASPiVLU (ASPirin in Venous Leg Ulcer) observational cohort study
Linked study record
ACTRN12614000293662

Health condition
Health condition(s) or problem(s) studied:
Venous Leg Ulcer 306308 0
Condition category
Condition code
Cardiovascular 305388 305388 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 305389 305389 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
This pragmatic observational cohort study is a prospective, multicentre observational cohort study that has been designed to follow patients with a venous leg ulcer who are deemed ineligible when screened for the ASPiVLU (ASPirin in Venous Leg Ulcer) study (ACTRN12614000293662).

This observational study will evaluate wound healing within 12 weeks from the baseline screening visit (primary outcome) and examine factors related to ulcer healing and recurrence within 24 weeks (secondary outcome).

Potential participants will be recruited by site investigators from participating ASPiVLU outpatient wound clinics in Victoria who are already screening for ASPiVLU Study. All consecutive patients screened for the ASPiVLU clinical trial will be offered observational cohort study participation if ineligible or unwilling to participate in the ASPiVLU clinical trial. Eligibility will be confirmed by Monash University research staff in consultation with a clinical consultant at each site.

Consenting patients will be followed for 24 weeks from the date of consent. A questionnaire will be given to the patient for completion at the baseline visit. Subsequent questionnaires will be mailed to the patient at 12 and 24 weeks from screen visit and followed up by phone if not returned within 2 weeks. Information will also be collected from the patient’s medical record. Patients who are unwilling or unable to complete questionnaires will have information collected only from their medical record at Baseline and 24 weeks.
Intervention code [1] 300109 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304532 0
The primary outcome is time to healing of target ulcer at 12 weeks. Healing is defined as 100% epithelialisation with no exudate or scab. Time to healing will be measured in weeks from date of consent / enrolment as clinically assessed by the treating clinician and documented in the patient's medical history.
Timepoint [1] 304532 0
12 weeks post-baseline
Secondary outcome [1] 342280 0
Time to healing of target ulcer: (24 weeks or until healed whichever comes first). Ulcer size and duration will be recorded from medical record wound assessment forms.
Timepoint [1] 342280 0
Until ulcer is healed, up to a maximum of 24 weeks post-baseline
Secondary outcome [2] 342281 0
Recurrence of target ulcer: (24 weeks) Absence of recurrence is defined as healed at 12 weeks and recurrence free at 24 weeks.
Timepoint [2] 342281 0
24 weeks post-baseline
Secondary outcome [3] 342283 0
Adherence to compression treatment: (12 and 24 weeks). Participants will be asked to report whether they adhere to wearing the compression on a categorical scale specific to this study of "wear every day", "wear most days (3 days per week or more)", "wear some days (less than 3 days per week)", "do not wear".
Timepoint [3] 342283 0
12 weeks and 24 weeks post-baseline
Secondary outcome [4] 342284 0
Health-related quality of life and wellbeing index: (Baseline, 12 and 24 weeks): The EQ-5D is a health related quality of life and wellbeing instrument.
Timepoint [4] 342284 0
12 weeks and 24 weeks post-baseline
Secondary outcome [5] 342285 0
Physical Activity: (Baseline, 12 and 24 weeks). Physical Activity will be assessed using the Rapid Assessment of Physical Activity (RAPA) questionnaire which asks participants to select one of seven statements which describe light, moderate or vigorous activity levels.
Timepoint [5] 342285 0
12 weeks and 24 weeks post-baseline
Secondary outcome [6] 342286 0
Nutritional Information: (Baseline, 12 and 24 weeks). The DETERMINE Checklist consist of ten statements which contribute to a nutritional score and assessment of nutritional risk. http://edis.ifas.ufl.edu/pdffiles/HE/HE94400.pdf Additional questions will examine the provision of nutritional advice to participants.
Timepoint [6] 342286 0
12 weeks and 24 weeks post-baseline

Eligibility
Key inclusion criteria
1. Age 18 years and older
2. Venous leg ulcers* present for at least six weeks or prior history of venous ulceration

* If patient has more than one wound, the largest at entry to study will be selected for measurement follow up
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All primary and secondary outcomes will be in the form of time to healing data and rates of complete healing that will be analysed using regression analysis to directly compare rates between groups.

Using a 95% Confidence Level and a margin of error of 0.08 we determined that we required 150 patients to address the primary objective of the proprtion healed at 12 weeks,

In July 2017, approval was granted for an additional 150 participants to be recruited making a total of 300 participants for the ASPiVLU observational cohort Study. The original 150 participants is the minimum sample size needed to address the primary objective of healing at 12 weeks. The larger number will make for a more representative sample allowing for better generalisability and reducing the effect of unanticipated missing data.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9848 0
Caulfield Hospital - Caulfield
Recruitment hospital [2] 9849 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [3] 9850 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 9851 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [5] 9852 0
The Alfred - Prahran
Recruitment postcode(s) [1] 18632 0
3162 - Caulfield
Recruitment postcode(s) [2] 18633 0
3081 - Heidelberg West
Recruitment postcode(s) [3] 18634 0
3021 - St Albans
Recruitment postcode(s) [4] 18635 0
3052 - Parkville
Recruitment postcode(s) [5] 18636 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 298468 0
Government body
Name [1] 298468 0
National Health and Medical Research Council
Address [1] 298468 0
GPO Box 1421
Canberra ACT 2601
Country [1] 298468 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Nursing and Midwifery
Level 3, 35 Rainforest Walk
Monash University
Wellington Road
Clayton, VIC 3800
Country
Australia
Secondary sponsor category [1] 297607 0
None
Name [1] 297607 0
Address [1] 297607 0
Country [1] 297607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299457 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 299457 0
99 Commercial Road
Melbourne Vic 3004
Ethics committee country [1] 299457 0
Australia
Date submitted for ethics approval [1] 299457 0
17/07/2016
Approval date [1] 299457 0
25/07/2017
Ethics approval number [1] 299457 0
HREC/14/Alfred/2 (Local Reference: Project 146/14)

Summary
Brief summary
The Wound Healing in Patients with Venous Leg Ulcer Observational Cohort Study is a prospective multicentre observational cohort study that has been designed to follow patients with a venous leg ulcer who are deemed ineligible when screened for the ASPiVLU Study. This observational cohort study will gather real world evidence about time to healing in people with venous leg ulcers who are unable to be recruited or refuse to participate in the ASPiVLU RCT. The observational cohort study will take advantage of the screening conducted for the RCT to identify patients for inclusion in the observational cohort study which will collect data from 300 patients by accessing their medical records twice and asking them to complete a questionnaire at three time points. As with the ASPiVLU RCT, the primary objective is to determine wound healing within 12 weeks from the baseline screening visit. The secondary objective is to examine factors related to ulcer healing and recurrence within 24 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80466 0
Prof Carolina Weller
Address 80466 0
Monash University
School of Nursing and Midwifery
Level 3, 35 Rainforest Walk
Wellington Road,
Clayton, VIC 3800
Country 80466 0
Australia
Phone 80466 0
+61 3 9903 0623
Fax 80466 0
Email 80466 0
carolina.weller@monash.edu
Contact person for public queries
Name 80467 0
Prof Carolina Weller
Address 80467 0
Monash University
School of Nursing and Midwifery
Level 3, 35 Rainforest Walk
Wellington Road,
Clayton, VIC 3800
Country 80467 0
Australia
Phone 80467 0
+61 3 9903 0623
Fax 80467 0
Email 80467 0
carolina.weller@monash.edu
Contact person for scientific queries
Name 80468 0
Prof Carolina Weller
Address 80468 0
Monash University
School of Nursing and Midwifery
Level 3, 35 Rainforest Walk
Wellington Road,
Clayton, VIC 3800
Country 80468 0
Australia
Phone 80468 0
+61 3 9903 0623
Fax 80468 0
Email 80468 0
carolina.weller@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no plans to share individual participant data
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary