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Trial registered on ANZCTR


Registration number
ACTRN12618000211268
Ethics application status
Approved
Date submitted
22/01/2018
Date registered
9/02/2018
Date last updated
9/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Compare the efficiency of two treatments used to remove unhealthy tissue from non-healing leg ulcers
Scientific title
Determine the effectiveness of low frequency ultrasonic debridement in the treatment of chronic venous leg ulcers
Secondary ID [1] 293836 0
Wound Management Innovation Cooperative Research Centre (WMI CRC) 3.37
Universal Trial Number (UTN)
U1111-1208-2325
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Leg Ulcer 306266 0
Condition category
Condition code
Cardiovascular 305367 305367 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 305483 305483 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to any treatment, a Nurse Practitioner(NP) (with 5 years experience) will complete baseline wound assessment, vascular assessment (to determine ankle/brachial index and an absolute toe pressure to exclude arterial insufficiency) and the participant will complete a baseline quality of life questionnaire. Wound assessments will then be repeated weekly by the NP for 12 weeks or until the ulcer is healed at the Silver Chain wound clinic visit prior to treatment. Base-line and on-going wound assessments will be recorded using a 3-dimensional laser digital planimetry system (Silhouette ARANZ) and Comcare Wound Module. The Silhouette planimetry system allows for accurate wound measurement. The NP will take a wound image using the 3-dimensional laser digital device which is uploaded on to a secured computer system. The outline of the image is then traced so as the program can then automatically calculate the wound tissue volume. Subsequent weekly wound volume calculations include the percentage of reduction or increase.and are automatically displayed on a wound healing graph to show the calculated variation in wound tissue volume. Comcare wound module is an electronic on-line wound assessment platform and is a secured database that facilitates assessment, care planning, analysis of healing outcomes and costs. Silhouette and Comcare assessment technologies will eliminate any data collection bias.

Participants who are randomised to receive Low Frequency Ultrasonic Debridement (LFUD) will have topical lignocaine 4% applied to the wound bed for 20 minutes prior to debridement treatments. They will then receive LFUD which will be delivered at 30-50 kHz by a handheld Sonaca probe, using normal saline solution as the coupling medium. The LFU will then be applied to the wound bed via the probe for 20 seconds per mm square ulcer area. The LFUD will be performed weekly until necrosis, signs of critical colonisation or localised infected tissue are eliminated. An average of 4 to 6 treatments per participant is expected. After each LFUD treatment, a silver antimicrobial dressing will be applied with a secondary absorbent pad and compression bandaging as clinically indicated by vascular assessment and participant tolerance (30-40mmHg is the recommended pressure for venous leg ulcers). Although LFUD has been reported to be well tolerated when used in conjunction with topical anaesthetic, should a participant not tolerate the procedure the therapy will be discontinued and an intention to treat analysis will be conducted.

If additional dressings are required between weekly NP treatments/reviews then this will be performed by the participants primary nurse who will adhere to the evidence based care plan established by the NP. All consumables used and nursing time taken to complete all wound care interventions for each participant will be recorded on their electronic Comcare Wound record.

Participants will be followed up by the NP weekly for 12 weeks or until the ulcer has healed., if this occurs earlier. In addition to the clinical outcome measures, quality of life will be measured using the Charring Cross assessment questionnaire both at baseline and final week of treatment.
Intervention code [1] 300094 0
Treatment: Devices
Comparator / control treatment
Participants randomised to the control group (Sharp Debridement) will also have topical lignocaine 4% applied to the wound bed for 20 minutes prior to debridement. They will then receive sharp debridement (SD) using a scalpel and/or curette. The SD will be performed weekly until the clinical signs of necrosis, critical or localised infected tissue are eliminated. As with LFUD it is anticipated that 4 to 6 debridement treatments will be needed. After each SD, the wound will be managed according to the same protocol as for the LFUD group. Although SD has been reported to be well tolerated when used in conjunction with topical anaestheic should a participant not tolerate the procedure the therapy will be discontinued and an intention to treat analysis will be conducted.
Control group
Active

Outcomes
Primary outcome [1] 304515 0
Compare the average proportional reduction in wound size achieved for chronic venous leg ulcers amongst participants who received low frequency ultrasonic debridement to those who received sharp debridment by using the Silhouette 3-dimensional laser digital planimetry system to measure the wound tissue volume. at baseline then weekly for 12 weeks or until healed (if this occurs before the 12 week time frame) A Cox regression analysis will then be conducted to compare the proportional reduction in wound size achieved between the two treatments.
Timepoint [1] 304515 0
Measurements will be completed at baseline and then weekly for 12 weeks or until healed (if this occurs before the 12 week period)
Primary outcome [2] 304516 0
Compare the cost of treatment between those participants who received low frequency ultrasonic debridement compared to those who received sharp debridment. The cost of all consumables used and the nursing time taken to treat the ulcer will be obtained from the participants electronic Silver Chain Comcare wound management system. The costs will be calculated by multiplying the number of treatments with nursing costs (including on-costs) plus the total consumable & dressing cost for each particpant's leg ulcer
Timepoint [2] 304516 0
12 weeks or less if ulcer heals before the 12 week period
Primary outcome [3] 304719 0
Compare the healing rates of chronic venous leg ulcers amongst participants who received low frequency ultrasonic debridement to those who received sharp debridement using the measurements taken from the Sihouette 3-dimensional laser digital planimetry system. A series of T-test will be used to compare the proportion of wounds healed between the two treatment groups
Timepoint [3] 304719 0
Weekly from week 2 to week 12 (end point)
Secondary outcome [1] 342216 0
Evaluate the quality of life impacts for those participants who receive low frequency ultrasonic debridement compared to those who receive sharp debridment using the Charring Cross Venous Leg Ulcer Tool
Timepoint [1] 342216 0
Baseline and at 12 weeks or completion of treatment (if this occurs before the 12 week period)

Eligibility
Key inclusion criteria
The inclusion criteria includes any participant who is currently receiving wound care by Silver Chain in the Perth Metropolitan area whose venous leg ulcer has been present for four weeks or longer and has failed to respond to autolytic debridement (hydration of necrotic tissue with dressings to facilitate spontaneous autolysis) or conservative sharp debridement and compression bandaging during the usual care period.. The ulcer measures 200mm x 200mm or less, confirmation of venous disease by an ankle brachial pressure index of 0.7-1.2 and/or an absolute toe pressure of 60mmHg or above, the ulcer presents with impaired healing, necrosis, signs and symptoms of critical colonisation or localised infection which is based on a set criteria established by the International Wound Infection Institute (Keast et al., 2014).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are under 18 years of age, have symptoms of an overt infection including cellulitis, underlying osteomyelitis or atypical pathophysiology; their leg ulcer has been present for more than 5 years and is greater than 200 x 200mm in dimensions; they are currently receiving chemotherapy or radiation therapy or have an underlying bleeding disorder, end-stage co-morbidity, internal defibrillator or unstable International Normalised Ratio (INR); or the ulcer has undergone previous LFUD.

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)
The study numbers (allocating the treatment intervention) will be individually placed in opaque sealed envelopes by Silver Chain research department and kept secured by the office administrator at the north service center where the clinic is based. The Nurse Practitioner will contact the office administrator at the time of recruitment inclusion assessment to determine which treatment group the participant is assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study numbers will be based on random assignment using a computer generated sequence of numbers which will be independently produced by Silver Chain research department.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
As the Nurse Practitioner is unable to be blinded to assessment data and treatments all electronic baseline and post-treatment assessments and wound images will be independently reviewed remotely by an expert wound practitioner employed by Silver Chain to eliminate any perceived bias. These remote and independent electronic assessments will be conducted using Comcare and only then be compared to those undertaken by the NP on the Silhouette program. This will ensure all assessment data is comparative and accurate to the data collected by the NP in the Silhouette program and that the images taken indicate debridement is clinically appropriate. The expert wound practitioner will be blinded to the treatment (debridement) intervention.
Phase
Type of endpoint(s)
Statistical methods / analysis
One hundred and forty participants with a venous leg ulcer who meet the inclusion criteria will be invited to participate in the study. The size sample has been calculated on the basis of an estimated difference between the groups in the average reduction in ulcer area of 15% and standard deviation of 30% at 12 weeks. The size of this differnece is a conservative judgement based on pilot work conducted by Silver Chain in Western Australia. A sample of 65 participants in each group (n=130) is required to be able to detect this difference with 80% powered at a 5% significance level (two sided). To allow for attrition, a sample of 70 participants in each group (n=140) will be recruited.

Statistical analyses will be carried out using the Statistical Package for the Social Sciences (SPSS), version 22. Descriptive statistics will be used to summarise the client characteristic, wound and cost data (care costs, consumable costs and time to healing costs)., and Cox Regression analysis will be conducted to compare the time to healing between LFUD and SD groups. A series of T-tests will compare the differences in the porportion of each wound healed between the groups. T-tests will also be used to compare the quality of life scores obtained from the two groups. Treatment costs for each participant will be calculated (care costs, consumable costs and time to healing costs) and analysis will involve input from a health economist.

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)
WA
Recruitment postcode(s) [1] 18616 0
6026 - Kingsley

Funding & Sponsors
Funding source category [1] 298450 0
Other Collaborative groups
Name [1] 298450 0
Wound Management Innovation CRC
Address [1] 298450 0
PO Box 2375
Toowong DC QLD 4066
Country [1] 298450 0
Australia
Funding source category [2] 298455 0
Other
Name [2] 298455 0
Silver Chain
Address [2] 298455 0
6 Sundercombe St
Osborne Park
WA 6017
Country [2] 298455 0
Australia
Funding source category [3] 298456 0
University
Name [3] 298456 0
Curtin University
Address [3] 298456 0
Kent Street
Bentley WA 6102
Country [3] 298456 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Wound Management Innovation CRC
Address
PO Box 2375
Toowong DC QLD 4066
Country
Australia
Secondary sponsor category [1] 297595 0
Other
Name [1] 297595 0
Silver Chain
Address [1] 297595 0
6 Sundercombe St
Osborne Park
WA 6017
Country [1] 297595 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299445 0
Silver Chain Human Research Ethics Committee
Ethics committee address [1] 299445 0
6 Sundercombe Street
Osborne Park WA 6017
Ethics committee country [1] 299445 0
Australia
Date submitted for ethics approval [1] 299445 0
10/11/2015
Approval date [1] 299445 0
04/12/2015
Ethics approval number [1] 299445 0

Summary
Brief summary
Chronic venous leg ulcers are a major health problem affecting approximately 1.1/1000 of the Western Australian population and previous community studies have shown that venous leg ulcers contribute to 50% of all wounds managed by community nurses. Although most leg ulcers will heal with compression bandages, approximately 20% fail to respond to this treatment possibly due to the presence of unhealthy tissue. Therefore this study is looking at two different types of debridement treatments used to breakdown the unhealthy tissue to encourage the dressings and compression bandaging to be more effective at healing the venous leg ulcers. Participants who have had a leg ulcer for more than 4 weeks but less than 5 years that have failed to respond to dressings and compression bandaging because of the presence of unhealthy tissue would be eligible to participate in the study. The participants after consent with be randomly assigned to either low frequency ultrasonic debridment or sharp debridement treatment on a weekly basis for a maximum of 12 weeks or less (if healing occurs before the 12 weeks) carried out by an experienced wound Nurse Practitoner and then have a silver dressing and compression bandaging applied. The wounds will be measured on a weekly basis using 3-dimensional laser digital planimetry system which is uploaded on a secured computer to allow automatic calculation of wound tissue volume including the percentage of reduction or increase. In addition the wound assessment and care plan will be completed using an electronic on-line secured platform (Comcare Wound Module) to analyse healing outcomes and costs for all treatments of all participants. Each participant will complete a quality of life assessment prior to commencement of treatment and on completion of the study.

The study will analyse the healing rates for both debridement treatments, compare the healing rates of the two treatments to determine which treatment was more effective and analyse the cost of healing for the two treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80426 0
Ms Elizabeth (Liz) Howse
Address 80426 0
Silver Chain North Service Centre
11 Moolanda Blvd
KINGSLEY WA 6026
Country 80426 0
Australia
Phone 80426 0
+61 410222012
Fax 80426 0
Email 80426 0
Liz.Howse@silverchain.org.au
Contact person for public queries
Name 80427 0
Ms Elizabeth (Liz) Howse
Address 80427 0
Silver Chain North Service Centre
11 Moolanda Blvd
KINGSLEY WA 6026
Country 80427 0
Australia
Phone 80427 0
+61 410222012
Fax 80427 0
Email 80427 0
Liz.Howse@silverchain.org.au
Contact person for scientific queries
Name 80428 0
Ms Elizabeth (Liz Howse
Address 80428 0
Silver Chain North Service Centre
11 Moolanda Blvd
KINGSLEY WA 6026
Country 80428 0
Australia
Phone 80428 0
+61 410222012
Fax 80428 0
Email 80428 0
Liz.Howse@silverchain.org.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