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Table 1 Participant inclusion and exclusion criteria

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

Inclusion criteria

Exclusion criteria

General:

General:

≥ 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:

Vascular:

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:

Ulcer Classification:

Infected ulcers being appropriately managed

Dry gangrenous ulcer

Those meeting The University of Texas Wound classification criteria[28]:

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)

Those meeting the University of Texas wound classification criteria[28]:

 

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)