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Trial registered on ANZCTR


Registration number
ACTRN12613001017718
Ethics application status
Approved
Date submitted
29/08/2013
Date registered
12/09/2013
Date last updated
27/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying effective new interventions to prevent recurrence of leg ulcers in adults with chronic venous insufficiency.
Scientific title
Does the Venous Insufficiency Program of Leg exercise and/or elevation (VIP Legs) prevent the recurrence of leg ulcers in adults with chronic venous insufficiency?
Secondary ID [1] 283106 0
Nil
Universal Trial Number (UTN)
Trial acronym
VIP Legs -
Venous Insufficiency Program of Leg exercise and/or elevation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous or mixed venous/arterial leg ulcer 289948 0
Chronic venous insufficiency 290020 0
Condition category
Condition code
Cardiovascular 290322 290322 0 0
Diseases of the vasculature and circulation including the lymphatic system
Physical Medicine / Rehabilitation 290323 290323 0 0
Physiotherapy
Skin 290402 290402 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clients who are attending the QUT Wound Healing Service for treatment of a venous or mixed venous/arterial leg ulcers will be invited to participate once their ulcer is healed.

Participation will involve:
- filling in a 20 minute questionniare (with questions on physical activity and quality of life) on recruitment and
again at 3 months, 6 months, 9 months and 12 months
- randomisation to one of 3 follow-up groups:

Group A will receive routine follow-up care as recommended by evidence based guidelines (i.e. routine advice and information on strategies to prevent ulcer recurrence) and be asked to attend the clinic for a check up at at 3 months, 6 months, 9 months and 12 months after healing.

Group B will also receive routine follow-up care as recommended by evidence based guidelines (i.e. routine advice and information on strategies to prevent ulcer recurrence) PLUS be given instruction, demonstration and information on the VIP Legs program of tailored lower limb exercises and leg elevation (for one hour/day); and asked to attend the clinic for a check up at 3 months, 6 months, 9 months and 12 months after healing.

Group C will also receive routine follow-up care as recommended by evidence based guidelines (i.e. routine advice and information on strategies to prevent ulcer recurrence) PLUS they will be given instruction and information on the VIP Legs program of leg elevation (for one hour/day); and asked to attend the clinic for a check up at 3 months, 6 months, 9 months and 12 months after healing.

At baseline a research nurse with experience in chronic venous insufficiency and trained by an exercise physiologist will go through the respective intervention booklets (group B and C) with each participant to ensure each participants has adequate understanding of the interventions. We expect this will require between 15-30 minutes of explanation and demonstration based on the individual participants needs at baseline.

Participants undertake the intervention programs by themselves in their own home over the intervention period.

Participants that are randomised to the VIP Legs program of leg elevation are encouraged to put their legs up at home at their convenience at a time that suits them, for a total of one hour/day.

Participants who are randomised to the VIP Legs program of lower leg exercises plus leg elevation will undertake the 1 hour of leg elevation per day and their tailored program of heel raises and walking for approximately 10-30 minutes/day at home.

The exercises include stretching, heel raises, and walking. There is no additional equipment that is required by those participants randomised to the exercise group. All of the exercises are individualised and progressive based on the capacity of the individual performing them. The concept of progression is one of self-management that is thoroughly described in the exercise booklet given. Therefore the participant increases the amount of sets / repetitions of heel raises before progressing to the next stage of difficulty. Therefore all participants start with being recommended to perform 10 repetitions, 3 sets, 3 times / day of seated heel raises until they can perform these comfortably for 3 days in a row.

The difference between Group B and Group C is that Group B are given a specific program of lower leg exercises (heel raises and walking) in addition to 1 hour/day of leg elevation; whereas Group C are only asked to do the 1 hour/day of leg elevation.

Individuals that are randomised into Group B or C both receive a diary booklet that requires them to complete daily time allocated to their respective intervention, i.e. time spent elevating legs or time spent performing lower limb exercises or both. At baseline participants are advised they will be required to bring their dairies to their follow up well leg check appointment to hand into the clinic nurse.



Intervention code [1] 287823 0
Treatment: Other
Intervention code [2] 287824 0
Prevention
Intervention code [3] 287825 0
Behaviour
Comparator / control treatment
Group A (control group) will receive routine follow-up care as recommended by evidence based guidelines (i.e. routine advice and information on strategies to prevent ulcer recurrence) and be asked to attend the clinic for a check up at at 3 months, 6 months, 9 months and 12 months after healing.
Control group
Active

Outcomes
Primary outcome [1] 290358 0
The primary outcome is incidence of leg ulcer recurrence.

Upon 3 monthly clinical assessment, i.e. a well leg check follow up appointments the participant is seen by a Nurse practitioner who performs a clinical examination. Participants will be advised to ring the clinic and make an appointment if they develop an ulcer recurrence between their regular appointments.
Timepoint [1] 290358 0
3 months, 6 months, 9 months and 12 months after healing.
Secondary outcome [1] 304356 0
Physical activity levels and types of physical activity using the Yale Physical Activity Survey
Timepoint [1] 304356 0
Baseline and at 3, 6, 9, 12 months after healing.
Secondary outcome [2] 304357 0
Social support using the Medical Outcomes Study Social Support Scale
Timepoint [2] 304357 0
Baseline and at 3, 6, 9, 12 months after healing.
Secondary outcome [3] 304572 0
Range of ankle Motion using bi-plane goniometry
Timepoint [3] 304572 0
Baseline only
Secondary outcome [4] 304573 0
Depression using the Geriatric Depression Scale
Timepoint [4] 304573 0
Baseline and at 3, 6, 9, 12 months after healing.
Secondary outcome [5] 304574 0
Self efficacy using the General Self-Efficacy Scale
Timepoint [5] 304574 0
Baseline and at 3, 6, 9, 12 months after healing
Secondary outcome [6] 304575 0
Health related quality of life using the SF-8
Timepoint [6] 304575 0
Baseline and at 3, 6, 9, 12 months after healing

Eligibility
Key inclusion criteria
* Clients diagnosed with a leg ulcer of venous or mixed venous/arterial aetiology which has healed within the previous four weeks from recruitment

* The ulcer is completely healed (where healing is defined as full epithelialisation of the ulcer which has been maintained for at least two weeks without breakdown)

* Clients with an Ankle Brachial Pressure Index (ABPI)
between 0.6 and 1.2
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clients who are unable to understand English

* Clients with a cognitive impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The method to be used to implement random allocation will be an envelope system where an independent source will prepare and order the envelopes to ensure that the sequence is concealed until groups are assigned to participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be carried out by an independent source using a computerised statistical package.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A sample of 150 patients will be recruited from QUT’s Wound Service (sample size calculation based on 90% power; 95% significance level; to detect a 0.2 difference in proportions between groups i.e. 30% vs 50% recurrence by 12 months; and allowing 20% loss to follow-up).

Descriptive analyses of all variables will be undertaken. A survival analysis approach will be taken to determine the effectiveness of the interventions on recurrence and identify differences between groups. Median times to recurrence for each group will be calculated and compared using the Kaplan-Meier method and log-rank test. A Cox proportional-hazards regression model will be used to determine differences between groups and adjust for potential confounders.

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)
QLD
Recruitment postcode(s) [1] 7297 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 287861 0
University
Name [1] 287861 0
Queensland University of Technology Vice Chancellor's Research Fellowship grant
Address [1] 287861 0
QUT Instititute of Health and Biomedical Innovation
60 Musk Ave
Kelvin Grove, Qld, 4059
Country [1] 287861 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
QUT Instititute of Health and Biomedical Innovation
60 Musk Ave
Kelvin Grove, Qld, 4059
Country
Australia
Secondary sponsor category [1] 286590 0
None
Name [1] 286590 0
Address [1] 286590 0
Country [1] 286590 0
Other collaborator category [1] 277594 0
University
Name [1] 277594 0
Queensland University of Technology Community Outreach Wound Healing Service
Address [1] 277594 0
QUT Health Clinics
44 Musk Avenue
Kelvin Grove QLD 4059
Country [1] 277594 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289804 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 289804 0
Research Ethics Unit
Office of Research
Level 4
88 Musk Avenue
Kelvin Grove
QLD
4059
Ethics committee country [1] 289804 0
Australia
Date submitted for ethics approval [1] 289804 0
Approval date [1] 289804 0
06/03/2013
Ethics approval number [1] 289804 0
1100001323

Summary
Brief summary
Venous leg ulcers are difficult and costly to heal, and unfortunately after healing, up to 70% of the ulcers recur. This study aims to obtain data on the effectiveness of a Venous Insufficiency Program of Leg exercise and/or elevation (VIP Legs) on prevention of venous or mixed venous/arterial leg ulcer recurrence. A randomised controlled trial will determine the effectiveness of VIP Legs interventions on health, quality of life and prevention of recurrence.
Participants will be randomised to one of 3 groups: the VIP Legs elevation program, the VIP Legs exercise and elevation program, or routine post-healing recommendations as per RCN
evidence-based guidelines. Participants in each group will be assessed upon healing, then at 3 months, 6 months, 9 months and 12 months after healing. Expected outcomes include early information on the interventions' effectiveness to provide urgently needed evidence on effective preventive strategies for this population.
Trial website
Trial related presentations / publications
* Finlayson K, Wu M-L, Edwards H. (2015) Identifying risk factors and protective factors for venous leg ulcer recurrence using a theoretical approach: a longitudinal study. International Journal of Nursing Studies, 52 (6): 1042–1051.

* Finlayson, K., Edwards, E. & Courtney, M. Relationships between preventive activities, psychosocial factors and recurrence of venous leg ulcers: a prospective study.
Journal of Advanced Nursing 04/2011; 67(10):2180-90.

* Finlayson, K., Edwards, E. & Courtney, M. Factors associated with recurrence of venous leg ulcers: a survey and retrospective chart review. International journal of nursing studies 01/2009; 46(8):1071-8.
Public notes

Contacts
Principal investigator
Name 42518 0
Dr Kathleen Finlayson
Address 42518 0
QUT Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove
Queensland
4059
Country 42518 0
Australia
Phone 42518 0
+61 7 3138 6105
Fax 42518 0
+61 7 3138 6050
Email 42518 0
k.finlayson@qut.edu.au
Contact person for public queries
Name 42519 0
Dr Kathleen Finlayson
Address 42519 0
QUT Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove
Queensland
4059
Country 42519 0
Australia
Phone 42519 0
+61 7 3138 6105
Fax 42519 0
+61 7 3138 6050
Email 42519 0
k.finlayson@qut.edu.au
Contact person for scientific queries
Name 42520 0
Dr Kathleen Finlayson
Address 42520 0
QUT Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove
Queensland
4059
Country 42520 0
Australia
Phone 42520 0
+61 7 3138 6105
Fax 42520 0
+61 7 3138 6050
Email 42520 0
k.finlayson@qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary