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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