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Trial registered on ANZCTR


Registration number
ACTRN12612000490875
Ethics application status
Approved
Date submitted
2/04/2012
Date registered
4/05/2012
Date last updated
21/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Is the healing rate in diabetes related foot ulcers improved with low frequency ultrasonic debridement versus non-surgical sharps debridement? A randomised control trial.
Scientific title
The effect of low frequency ultrasonic debridement therapy versus non-surgical sharps debridement on wound healing in diabetes related foot ulcers.
Secondary ID [1] 280220 0
Nil
Universal Trial Number (UTN)
U1111-1129-4780
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes related foot ulceration. 286161 0
Condition category
Condition code
Skin 286352 286352 0 0
Other skin conditions
Metabolic and Endocrine 286552 286552 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low frequency ultrasonic debridement therapy. LFUD delivers a constant flow of saline through which low frequency ultrasound is delivered. The impact of the ultrasound in the saline close to the wound surface (either direct contact or held up to 1cm away) causes: 1. Acoustic streaming (steady current delivered in a fluid medium i.e. sterile saline) 2. Cavitation (imploding ‘gaps’ in the fluid creating micro-shockwaves). In turn, these impacts result in three clinical effects: 1. Debridement 2. Bactericidal effects 3. Wound healing stimulatory effects Whilst low frequency ultrasonic debridement, can also be performed by podiatrists and wound clinical nurse consultants it differs from non-surgical sharps debridement as it is not dependent upon the clinicans skill to determine what tissue should be removed. Treatments are perfromed weekly until the wound is healed. The low frequency of the ultrasound transmitted through the liquid medium (sterile saline solution) selectively debrides the wound base, leaving healthy and viable tissue intact only removing infected and necrotic tissue thus making it safer for patients. Additionally, this treatment is less painful and has additional benefits when compared to non-surgical sharps debridement including that its action is also bactericidal and stimulates the phases of healing. This suggests an acceralated healing time for ulcers. Each treatment session take 60 minutes and includes assessment and treatment. LFUD is utilised for 30 seconds per centimetre square of the wound size, at its widest and longest points. This treatment will be utilised for the first 6 weeks from recruitment and then the ulcer will be reviewed to determine if there is a clinical indication to continue utilising the therapy. If there is the indication to continue the therapy then no changes will be made. If there is no clinical indication to continue the therapy then particpants will receive the control treatment, which is also standard practice, (Non-surgical sharps debridement) and will remain in the study.
Intervention code [1] 284548 0
Treatment: Devices
Comparator / control treatment
Non-surgical sharps debridement.

Standard practice for ulcer debridement by podiatrists and wound clinic nurse consultants is non-surgical sharps debridement. Non-surgical sharps debridement depends upon the skill of the clinician and the ability for them to distinguish between healthy and necrotic tissue. This treatment can often be painful and risks with treatment include bleeding, damage to healthy and vital tissue (e.g. nerves, tendon and ligaments) with a resultant loss in function.


Each treatment session take 60 minutes and includes assessment and treatment. Sharps debridement is undertaken until as much necrotic and devitalised tissue has been removed from the wound bed, there is no time limit. This treatment will be utilised until the wound has healed or is 100% epithelialised.
Control group
Active

Outcomes
Primary outcome [1] 286870 0
This study aims to compare healing rates for diabetes related foot ulcers using non-surgical sharps debridement versus low frequency ultrasonic debridement.
Timepoint [1] 286870 0
Wounds will be measured following each treatment to determine total ulcer area in centimetres squared until the time of healing or completion of the study. Percentage of necrotic tissue is no longer being included in this study.
Secondary outcome [1] 296868 0
Economic evaluation: cost effectiveness analysis of both direct and indirect health care costs will be determined at the completion of the study.
Timepoint [1] 296868 0
1 week post final treatment.
Secondary outcome [2] 296869 0
Number of complications that resulted from either method of ulcer debridement including:
- Number of amputations required
- Number of surgical debridements required
- Number of infections developed
Timepoint [2] 296869 0
1 week post final treatment.
Secondary outcome [3] 301933 0
Wound pain assessment
Timepoint [3] 301933 0
All wounds will be assessed for pain using the visual analogue pain scale prior, during and after each treatment.
Secondary outcome [4] 301934 0
Cost utility analysis using a quality of life tool EQ-5D-5L.
Timepoint [4] 301934 0
This will be conducted at the initial assessment, mid way through the study (at 3 months) and again at the end of the study (at 6 months or when healed, whichever occurs first) for each participant.

Eligibility
Key inclusion criteria
- Equal to and greater that 30 years of age
- Able to provide informed consent
- Wounds greater than 1cm squared in total area
- Wounds present for greater than 1 month
- Vascular assessment: Palpable pedal pulses OR toe pressure equal to or greater than 45mmHg OR meeting stages 0 (asymptomatic), 1 (mild claudication) and 2 (moderate claudication at 200m) of the Rutherford Classification for peripheral arterial disease
- Infected ulcers being appropriately managed
- Ulcers meeting The University of Texas wound classification criteria: A1, A2, A3 (wounds of varying depth without infection or ischaemia) and B1, B2, B3 (wounds of varying depth with infection only)
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants taking immunosuppressive medication
- Known allergies to wound dressing products
- Pre-existing ulcer pain preventing either type of debridement
- Vascular assessment: meeting stages 3 (severe classification), 4 (rest pain), 5 (ischaemic ulceration not exceeding ulcer of the digits of the foot) and 6 (severe ischaemic ulcers or frank gangrene) of the Rutherford Classification for peripheral arterial disease
- Dry gangrenous ulcers
- Fungating ulcers
- Malignant ulcers
- Those meeting the University of Texas Wound Classification Criteria: A0, B0, C0, D0 (pre or post-ulcerative lesion with complete epithelialisation, with or without infection and ischaemia), C1, C2, C3 (wounds with varying depth and ischaemia only), D1, D2, D3, (wounds with varying depth with ischaemia and infection)

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)
Patients with diabetes and foot ulcers that are referred to and treated by Podiatry at Southern Health will be recruited into this study. Only patients who meet the inclusion criteria will be invited to participate. These patients will be randomised into two groups. Group 1: Non-surgical sharps debridement and Group 2: LFUD.

Standard initial podiatric assessment will occur including a neurovascular assessment, medical and surgical history, medications history, diabetes management and control history including Hba1c, footwear assessment, wound aetiology, duration and previous management. At this time, the patient will be informed about the research project and verbal and written consent will be obtained to participate in the study, if the patient meets the inclusion criteria.

Allocation will be concealed using opaque and sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The proportion of ulcers that are completed healed by the six month follow-up will be compared between groups using a logistic regression analysis approach with clustering of ulcer within participant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
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] 791 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 285026 0
Charities/Societies/Foundations
Name [1] 285026 0
Lions John Cockayne Memorial Fellowship Trust Fund
Address [1] 285026 0
Professor Barbara Workman
Southern Health
Kingston Centre
Warrigal Rd
CHELTENHAM VIC 3192
Country [1] 285026 0
Australia
Primary sponsor type
Individual
Name
Lucia Michailidis
Address
Podiatrist
Southern Health
Kingston Centre
Warrigal Rd
CHELTENHAM VIC 3192
Country
Australia
Secondary sponsor category [1] 283992 0
Individual
Name [1] 283992 0
Ms Cylie Williams
Address [1] 283992 0
Allied Health Research Unit
Kingston Centre
Warrigal Rd
CHELTENHAM VIC 3192
Country [1] 283992 0
Australia
Secondary sponsor category [2] 283993 0
Individual
Name [2] 283993 0
Associate Professor Terry Haines
Address [2] 283993 0
Allied Health Research Unit
Kingston Centre
Warrigal Rd
CHELTENHAM VIC 3192
Country [2] 283993 0
Australia
Secondary sponsor category [3] 285730 0
Individual
Name [3] 285730 0
Dr Shan Bergin
Address [3] 285730 0
Podiatry Department
Dandenong Hospital
135 David Street, Dandenong
VIC, 3175
Country [3] 285730 0
Australia
Secondary sponsor category [4] 285731 0
Individual
Name [4] 285731 0
Dr Jennifer Wong
Deputy Director of Diabetes Department
Address [4] 285731 0
Dandenong Hospital Diabetes Unit,
Level 2, 105 David Street
Dandenong
VIC, 3175
Australia
Country [4] 285731 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287027 0
Southern Health HREC
Ethics committee address [1] 287027 0
Research Directorate
Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 287027 0
Australia
Date submitted for ethics approval [1] 287027 0
04/04/2012
Approval date [1] 287027 0
03/08/2012
Ethics approval number [1] 287027 0
12101B

Summary
Brief summary
Low frequency ultrasonic debridement is a new treatment approved for use at Southern Health to treat diabetes related foot ulcers.
This project aims to assess if the use of low frequency ultrasonic debridement to treat diabetes related foot ulcers can achieve faster ulcer healing than standard non-surgical sharps debridement.
The current research around the use of low frequency ultrasonic debridement to treat diabetes related foot ulcers is positive and suggests that this therapy leads to faster healing and is potentially les painful that other therapies. There is very little evidence comparing low frequency ultrasonic debridement with other ulcer debriding therapies for diabetes related foot ulcers.
Trial website
Trial related presentations / publications
1. Michailidis L, Williams C, Bergin S, Haines T: Comparison of healing rate in diabetes-related foot ulcers with low frequency ultrasonic debridement versus non-surgical sharps debridement: a randomised trial protocol. Journal of Foot and Ankle Research 2014, 7.

2. Michailidis L, Kotsanas D, Orr E, Coombes G, Bergin S, Haines T, Williams C: Does the new low frequency ultrasonic debridement technology pose an infection control risk for clinicians, patients, and the clinic environment? Am J Infect Control 2016, 44:1656-1659.

Public notes

Contacts
Principal investigator
Name 33977 0
Ms Lucia Michailidis
Address 33977 0
Podiatry Department Southern Health Kingston Centre Warrigal Rd CHELTENHAM VIC 3192 AUSTRALIA
Country 33977 0
Australia
Phone 33977 0
+61 03 95942382
Fax 33977 0
Email 33977 0
lucia.michailidis@southernhealth.org.au
Contact person for public queries
Name 17224 0
Ms Lucia Michailidis
Address 17224 0
Podiatry Department
Southern Health
Kingston Centre
Warrigal Rd
CHELTENHAM VIC 3192
AUSTRALIA
Country 17224 0
Australia
Phone 17224 0
+61 03 95942382
Fax 17224 0
Email 17224 0
lucia.michailidis@southernhealth.org.au
Contact person for scientific queries
Name 8152 0
Ms Lucia Michailidis
Address 8152 0
Podiatry Department
Southern Health
Kingston Centre
Warrigal Rd
CHELTENHAM VIC 3192
AUSTRALIA
Country 8152 0
Australia
Phone 8152 0
+61 03 95942382
Fax 8152 0
Email 8152 0
lucia.michailidis@southernhealth.org.au

No data has been provided for results reporting
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