Introduction
Background
Methods
Study design
Ethical consideration
Participants and setting
Inclusion criteria | Exclusion criteria |
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General:
|
General:
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≥ 30 years of age | Patients taking immunosuppressive medications |
Able to provide informed consent | Known allergy to ulcer dressing products |
Ulcers present for greater than 1 month | Pre-existing ulcer pain preventing either type of debridement |
Ulcers ≥ 1 cm2
| |
Vascular:
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Vascular:
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Palpable pedal pulses OR biphasic or triphasic pedal pulses on doppler OR toe pressure ≥ 45 mmHg | Non-palpable pedal pulses OR monophasic pedal pulses on Doppler OR toe pressure ≤ 45 mmHg |
Ulcer classification:
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Ulcer Classification:
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Infected ulcers being appropriately managed | Dry gangrenous ulcer |
Fungating ulcers | |
A1, A2, A3 (wounds of varying depth without infection or ischaemia)
| Malignant ulcers |
B1, B2, B3 (wounds of varying depth with infection only)
| |
A0, B0, C0, D0 (pre or post-ulcerative lesion with complete epithelialisation, with or without infection and ischaemia)
| |
C1, C2, C3 (wounds of varying depth with ischaemia only)
| |
D1, D2, D3 (wound of varying depth with infection and ischaemia)
|
Interventions
LFUD | NSSD |
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1) Constantly move the handpiece to prevent ultrasound burning tissue | 1) Start debriding at the distal most aspect of the ulcer |
2) Start debriding at the distal most aspect of the ulcer | 2) Moving scalpel proximally with each motion |
3) Moving the handpiece left to right and from the distal to proximal aspect of the ulcer | 3) Once the distal to proximal ulcer has been debrided then debride from left side to right side |
4) Once the entire ulcer surface has been debrided re-commence the same technique from the distal most aspect of the ulcer | 4) Continue until as much necrotic tissue has been removed as possible |
5) Any peri-wound tissue that requires removal (i.e. callus, maceration) will occur using a scalpel. | |
5) Continue until as much necrotic tissue has be removed as possible | |
6) Any peri-wound tissue that requires removal (i.e. callus, maceration) will occur using a scalpel. The wound base will not be debrided with the scalpel. |
Outcome measures
Primary outcome measure
Ulcer measurement | |
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1) | Ulcers that have tunnels or undermining will be marked on the skin with a black marker |
2) | A white towel will be place under the foot to remove distracting background elements |
3) | A disposable ruler will be labelled with participant number, wound number, participant initials and the date |
4) | Position the disposable ruler alongside the ulcer and secure with paper tape |
5) | Use macro camera setting with flash on, iso set to 200 |
6) | Take photograph at a distance of 20 cm from the wound |
7) | Ulcer measurements will be conducted from print out using the photograph (all photos will be printed as standard A4 size) |
Secondary outcome measures
Data collection
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Measurement tool
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Data collected method
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Timeframe
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---|---|---|---|
Measurement of total ulcer area
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Centimetres squared;
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Research assistant
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Weekly: Post-treatment until healed or at 6 months
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Tracing from photographs and counting squares
| |||
Measurement of ulcer depth
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Centimetres;
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Treating podiatrist
|
Weekly: post-treatment until healed or at 6 months
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Using sterile probe
| |||
Ulcer pain
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Visual analogue pain scale 100 mm
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Treating podiatrist
|
Weekly: Pre-treatment, during treatment, post-treatment until healed or 6 months
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Quality of life
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EQ-5D-5 L tool
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Participant questionnaire
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Initial treatment, at 3 months, at 6 months
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Direct health costs
| |||
Consumable costs for treatments
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In dollars for each treatment
|
Treating podiatrist
|
Weekly, per participant until healed or at 6 months
|
Medicare Benefit Scheme (MBS)
|
MBS Care database, in dollars
|
Extraction from MBS database
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End of project for each participant from initial to final treatment
|
Pharmaceutical Benefit Scheme (PBS)
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PBS Care database, in dollars
|
Extraction from PBS database
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End of project for each participant from initial to final treatment
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Inpatient data
|
Monash Health:
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Hospitalisation costs
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Monash Health:
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Admission duration, reason for admission, imaging and interventions, obtained from the patient record and from the Victorian Admitted Episodes Database
|
End of project
| ||
External organisation: End of project
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External organisation: Admission duration, reason for admission, costs of any surgery for diabetes-related foot ulcers will be estimated using WEISS funding
| |||
Hospital based services (outpatient data)
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Hours – time spent
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Treating podiatrist
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Weekly per participant until healed or at 6 months
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Medical imaging and pathology for outpatients
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Dollars – hospital based costs
|
Treating podiatrist
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Monthly per participant until healed or at 6 months
|
Community based services
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Number and cost of appointments
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Participant interview
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Monthly until healed or at 6 months
|
Private health appointments
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Number and cost of appointments, eligibility for private health subsidies
|
Participant interview
|
Monthly until healed or at 6 months
|
Royal District Nursing Service for ulcer management
|
Frequency and cost of service
|
Participant interview
|
Monthly until healed or at 6 months
|
Ongoing ulcer care products
|
Valued using market prices
|
Participant interview
|
Monthly until healed or at 6 months
|
Parking costs for appointments
|
Dollars
|
Participant interview
|
Monthly until healed or at 6 months
|
Transportation costs to travel to appointments
|
Estimated through Australian Tax Office car rate cents per km
|
Participant interview
|
Monthly until healed or at 6 months
|
Productivity costs
| |||
Time taken from work for participant and/or any family member
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Salary and hours taken from work
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Participant/family interview
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Monthly until healed or at 6 months
|