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Trial registered on ANZCTR


Registration number
ACTRN12616000490471
Ethics application status
Approved
Date submitted
11/04/2016
Date registered
14/04/2016
Date last updated
3/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Venous leg ulcers, topical negative pressure and compression study
Scientific title
RCT of topical negative pressure wound therapy in addition to compression bandaging in venous leg ulcer healing
Secondary ID [1] 288968 0
Nil known
Universal Trial Number (UTN)
U1111-1181-7641
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous leg ulcers 298351 0
Condition category
Condition code
Cardiovascular 298463 298463 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive washing of the limb and wound in potable water, application of moisturiser to the lower leg, conservative sharp wound debridement if necessary, application of a silicone negative pressure wound therapy dressing with battery operated pump (which applies 80mmHg continuous negative pressure (PICO Trademark) )and four layer compression bandaging. Acquired wound infection will be treated with nanocrystalline silver dressings. If patients are unable to tolerate nanocrystalline silver (5% estimated), cadexomer iodine will be used. Wound washing, moisturising, debridement and dressing application will be attended by a registered nurse. The decision to perform wound debridement will be made by the treating registered nurse based on the presence of loose avascular tissue in the wound bed and whether in her clinical opinion it can be safely removed.
The Silhouette (Trademark) (ARANZ) device will used to collect accurate, reproducible, laser calibrated, three dimensional wound measurements at weekly intervals.
Dressings will be attended twice weekly for twelve weeks or until the treating registered nurse decides that the wound no longer requires dressing.
Adherence to the treatment regime will be evidenced by an intact dressing at time of next treatment. Variations from this treatment will be documented in the participant's record.
The Charing Cross Venous Leg Ulcer Tool will be used to determine the quality of life impact of a venous leg ulcer and each of the study treatments.
The EQ-5D-5L tool will be used to measure quality adjusted life years.
These self assessment tools will be completed at first, thirteenth and final treatments.
Intervention code [1] 294455 0
Treatment: Devices
Comparator / control treatment
The control group will receive washing of the limb and wound in potable water, application of moisturiser to the lower leg, conservative sharp wound debridement if necessary, a primary dressing of tulle gras, secondary absorbent pad and four layer compression bandaging. Acquired wound infection will be treated with nanocrystalline silver dressings. If patients are unable to tolerate nanocrystalline silver (5% estimated), cadexomer iodine will be used.. Wound washing, moisturising, debridement and dressing application will be attended by a registered nurse. The decision to perform wound debridement will be made by the treating registered nurse based on the presence of loose avascular tissue in the wound bed and whether in her clinical opinion it can be safely removed
The Silhouette (Trademark) (ARANZ) device will used to collect accurate, reproducible, laser calibrated, three dimensional wound measurements at weekly intervals. Dressings will be attended twice weekly for twelve weeks or until the treating registered nurse decides that the wound no longer requires dressing.
The Charing Cross Venous Leg Ulcer Tool will be used to determine the quality of life impact of a venous leg ulcer and each of the study treatments.
The EQ-5D-5L tool will be used to measure quality adjusted life years.
These self assessment tools will be completed at first, thirteenth and final treatments.
Control group
Active

Outcomes
Primary outcome [1] 297955 0
Time to healing ie complete epithelialisation of the wound bed. This is assessed visually by the treating nurse and confirmed using the SIlhouette (Trademark) wound imaging device,where a wound area = 0 will indicate complete healing.
Timepoint [1] 297955 0
Participants will be treated until healing is complete or twelve weeks, whichever is the sooner.Wound healing will be assessed visually by the registered nurse at each treatment and digitally using the Silhouette (Trademark) wound imaging device weekly until the wound is healed.
Analysis will be performed at completion of treatment phase of trial.
Secondary outcome [1] 322755 0
Differences in mean percentage healing between groups. Percentage healing is calculated for each wound by the Silhouette (Trademark) wound imaging device. The mean for each group will be calculated and t-tests used to identify difference in mean between each group.
Timepoint [1] 322755 0
Participants will be treated until healing is complete or twelve weeks, whichever is the sooner. Wound healing will be assessed visually by the registered nurse at each treatment and digitally using the Silhouette (Trademark) wound imaging device weekly until the wound is healed.
Analysis will be performed at completion of treatment phase of trial.
Secondary outcome [2] 322756 0
Quality of life (QoL) impacts. The EQ-5D-5L quality of life assessment tool and the Charing Cross Venous Leg Ulcer Tool will be used to assess quality of life.
Timepoint [2] 322756 0
Participants will be treated until healing is complete or twelve weeks, whichever is the sooner. Analysis will be performed at completion of treatment phase of trial.The EQ-5D-5L quality of life assessment tool and the Charing Cross Venous Leg Ulcer Tool will be completed by participants at first, thirteenth and final visits. unless healed before the thirteenth visit then only first and final visits.
Secondary outcome [3] 322757 0
Economic analysis of treatment outcomes and quality adjusted life years (QALYs). Data colletion will be undertaken using EQ-5D-5L and Charing Cross Venous Leg Ulcer Tool.
Timepoint [3] 322757 0
12 weeks post initial dressing application or should the participant heal before twelve weeks of treatment , at the time point when the participant's wound is declared healed..
Secondary outcome [4] 322758 0
Incidence of wound infection.
Wound infection will be identified using criteria for identifying infection in chronic wounds publicised by the World Union of Wound Healing Societies (2008). These criteria are reproduced below.
Localised infection
New, increased or altered pain
Delayed (or stalled) healing
Periwound oedema
Bleeding or friable (easily damaged) granulation tissue
Distinctive malodour or change in odour
Wound bed discoloration
Increased or altered/purulent exudate
Induration
Pocketing
Bridging
Spreading infection: As for localised infection PLUS:
Wound breakdown
Erythema extending from wound edge
Crepitus, warmth, induration or discoloration spreading into periwound area
Lymphangitis
Malaise or other non-specific deterioration

(World Union of Wound Healing Societies. (2008). Principles of best practice: wound infection in clinical practice. an international consensus. Lomdon: MEP Ltd., p3. Retrieved 12 April 2016 from http://www.woundsinternational.com/media/issues/71/files/content_31.pdf.)

Wound infection will be confirmed by collection of wound swab and pathology report..
Timepoint [4] 322758 0
Throughout the treatment phase which may be twelve weeks or less if the participant's wound is healed prioir to this time.

Eligibility
Key inclusion criteria
Patients referred to the vascular service at Sir Charles Gairdner Hospital (SCGH), Western Australia for treatment of a venous leg ulcer which
Measures >2cm2 and <20cm2.
Ankle-brachial pressure index (ABPI) between 0.8-1.2
No muscle, tendon or bone visible
Able to attend twice weekly clinics
English-speaking
Over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetic neuropathy or atypical ulcer diagnosis
Dementia
Anticoagulant use
Infection at recruitment
Uncontrolled immunosuppressive disorders
Previous negative pressure wound therapy use for that ulcer.

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)
Patient will be assigned randomised number in order of recruitment to trial.
Treatment eligilbity is assessed by Dr Shirley Jansen, Head of Department Vascular and Endovascular Surgery and Dr Joseph Hockley, Vascular Consultant, Sir Charles Gairdner Hospital who will be unaware of the treatment arm to which the participant will be assigned. Eligibility will be decided at Sir Charles Gairdner Hospital Ulcer Clinic.. Treatment arm allocation will be done by the treating registered nurse, who is situated at The Heart Research Institute at The Harry Perkins Medical Research Institute. in strict order of recruitment to the trial based on a computerised sequence of random numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
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
Sample size calculation was assisted by Drs Parsons and Spilsbury, Biostatisticians, Curtin University, using the Stata statistical software. The conservative assumption made is that 60% of patients in the control group will heal in 3 months (Australian Wound Management Association Inc & New Zealand Wound Care Society, 2011; Simon et al., 2004). Previously published pilot data causes us to anticipate that the intervention will halve the healing time (i.e. that 60% of patients will heal in 6 weeks). With 90% power and an alpha value of 0.05, and assuming that up to 20% of patients will be lost to follow-up, 150 patients in total (75 patients in each arm), will be required to demonstrate whether there is a statistically significant difference in the key outcome measures of time to heal and cost effectiveness between the two groups.
Data will be input into a database using SPSS software version 22. A p value of <0.5 will be considered to indicate statistical significance. Intention to treat analysis will be used.
Descriptive statistics (means and standard deviations) will be used to analyse demographic data. Chi-square analysis of categorical variables and t-test for continuous variables will be used to assess the differences between control and intervention groups. Homogeneity of demographic data will support the premise that the randomisation process was appropriate and group size adequate.
A series of t-tests will be used to compare outcomes between groups at baseline. Mixed regression analysis will be performed to compare change over time between intervention and control groups. Effect size will be based on the average time to healing as a correlation of the two variables as the regression coefficient. Quality of life scores will be analysed using descriptive statistics. T-test comparison of the two scores will permit analysis of the effect of treatment arm on QoL.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2016
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5589 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 293326 0
Other Collaborative groups
Name [1] 293326 0
Wound Management Innovation Collaborative Research Centre (WMI CRC)
Country [1] 293326 0
Australia
Funding source category [2] 293327 0
University
Name [2] 293327 0
Curtin University
Country [2] 293327 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
17 Monash Avenue, Nedlands Western Australia 6009
Country
Australia
Secondary sponsor category [1] 292144 0
Commercial sector/Industry
Name [1] 292144 0
Smith & Nephew
Address [1] 292144 0
85 Waterloo Road North,
Ryde New South Wales 2113
Country [1] 292144 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294796 0
Sir Charles Gairdner Group Human Research Ethics Committee,
Ethics committee address [1] 294796 0
Level 2 A Block, Hospital Ave, Nedlands, WA 6009
Ethics committee country [1] 294796 0
Australia
Date submitted for ethics approval [1] 294796 0
23/02/2016
Approval date [1] 294796 0
22/04/2016
Ethics approval number [1] 294796 0

Summary
Brief summary
Venous leg ulcers (VLU) account for 80% of all leg ulcers. They adversely affect quality of life and exact a financial burden on individuals and the health care sector. The use of graduated compression is considered ‘gold standard’ for the treatment of venous leg ulceration. Negative pressure wound therapy (NPWT), used in the management of wounds, has been found to reduce time to healing. However, no robust studies exist which compare the healing rates of VLU treated with compression bandaging and NPWT as compared to those treated with compression bandaging alone.

Aim: To investigate the effectiveness of NPWT and four layer compression bandaging (4LCB) as compared to 4LCB and usual treatment, for healing venous leg ulcers.

Objectives:
1. To investigate the efficacy of NPWT dressings and 4LCB as compared to usual treatment and 4LCB for healing VLUs.
2. To determine the impact of a VLU and its treatment on quality of life (QoL).
3. To conduct a prospective economic analysis to determine the costs associated with healing VLUs and the effect on quality adjusted life years (QALYs).

Method: A single site two arm RCT with 150 patients, randomised to two groups of 75 will be undertaken. Patients will receive NPWT dressings and 4 LCB or usual treatment (tulle gras wound contact layer and absorbent pad) and 4 LCB for 12 weeks, or less if healed prior to 12 weeks. Ulcerated legs will be graded according to the CEAP classification. The Silhouette (Trademark) (ARANZ) device will be used to collect measurements. The EQ-5D-5L Tool and the Charing Cross Venous Leg Ulcer Tool (CXVLU) will be used to determine the impact of the VLU and treatments on quality of life and quality adjusted life years. Statistical analysis of healing times and QoL will be performed using t-test and regression analysis. A prospective economic analysis will be performed to determine the costs associated with healing VLUs and QALY.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 65074 0
A/Prof Shirley JANSEN
Address 65074 0
Dept Vascular Surgery, level 6 G block, Sir Charles Gairdner Hospital, Hospital Avenue
Nedlands
WA
6009
Country 65074 0
Australia
Phone 65074 0
+61409373786
Fax 65074 0
Email 65074 0
[email protected]
Contact person for public queries
Name 65075 0
Shirley JANSEN
Address 65075 0
Dept Vascular Surgery, level 6 G block, Sir Charles Gairdner Hospital, Hospital Avenue
Nedlands
WA
6009
Country 65075 0
Australia
Phone 65075 0
+61409373786
Fax 65075 0
Email 65075 0
[email protected]
Contact person for scientific queries
Name 65076 0
Shirley JANSEN
Address 65076 0
Dept Vascular Surgery, level 6 G block, Sir Charles Gairdner Hospital, Hospital Avenue
Nedlands
WA
6009
Country 65076 0
Australia
Phone 65076 0
+61409373786
Fax 65076 0
Email 65076 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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