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Table 4 Outcome measures and timeframes

From: Comparison of healing rate in diabetes-related foot ulcers with low frequency ultrasonic debridement versus non-surgical sharps debridement: a randomised trial protocol

Data collection Measurement tool Data collected method Timeframe
Measurement of total ulcer area Centimetres squared; Research assistant Weekly: Post-treatment until healed or at 6 months
Tracing from photographs and counting squares
Measurement of ulcer depth Centimetres; Treating podiatrist Weekly: post-treatment until healed or at 6 months
Using sterile probe
Ulcer pain Visual analogue pain scale 100 mm Treating podiatrist Weekly: Pre-treatment, during treatment, post-treatment until healed or 6 months
Quality of life EQ-5D-5 L tool Participant questionnaire Initial treatment, at 3 months, at 6 months
Direct health costs
Consumable costs for treatments 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 End of project for each participant from initial to final treatment
Pharmaceutical Benefit Scheme (PBS) PBS Care database, in dollars Extraction from PBS database End of project for each participant from initial to final treatment
Inpatient data Monash Health: Hospitalisation costs Monash Health:
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
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) Hours – time spent Treating podiatrist Weekly per participant until healed or at 6 months
Medical imaging and pathology for outpatients Dollars – hospital based costs Treating podiatrist Monthly per participant until healed or at 6 months
Community based services Number and cost of appointments Participant interview Monthly until healed or at 6 months
Private health appointments 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 Salary and hours taken from work Participant/family interview Monthly until healed or at 6 months