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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)