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Table 1 Participant inclusion and exclusion criteria

From: Healing rates in diabetes-related foot ulcers using low frequency ultrasonic debridement versus non-surgical sharps debridement: a randomised controlled trial

Inclusion criteria Exclusion criteria
General: ≥ 30 years of age Able to provide informed consent Ulcers present for ≥ 1 month Ulcers ≥ 1 cm2 General: Patients taking immunosuppressive medications Known allergy to ulcer dressing products Pre-existing ulcer pain preventing either type of debridement
Vascular: Palpable pedal pulses OR toe pressure ≥ 45 mmHg OR those meeting Rutherford Classification of peripheral arterial disease stages [13]: 0 (Asymptomatic) 1 (Mild claudication) 2 (Moderation claudication at 200 m) Vascular: Those meeting Rutherford Classification of peripheral arterial disease stages: 3 (Severe claudication) 4 (Rest pain) 5 (Ischaemic ulceration no exceeding ulcer of the digits of the toes) 6 (Severe ischaemic ulcers of frank gangrene)
Ulcer classification: Infected ulcers being appropriately managed Those meeting The University of Texas Wound classification criteria [14]: A1, A2, A3 (wounds of varying depth without infection or ischaemia) B1, B2, B3 (wounds of varying depth with infection only) Wound classification: Dry gangrenous ulcer Fungating ulcers Malignant ulcers Those meeting the University of Texas wound classification criteria: 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