The effect of low frequency ultrasonic debridement therapy versus non-surgical sharps debridement on wound healing in diabetes related foot ulcers.

ucia Michailidis0 个研究点目标入组 108 人开始时间: 2012年5月4日最近更新: 2020年1月13日

适应症

试验速览

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•Equal to and greater that 30 years of age
•- Able to provide informed consent
•- Wounds greater than 1cm squared in total area
•- Wounds present for greater than 1 month
•- Vascular assessment: Palpable pedal pulses OR toe pressure equal to or greater than 45mmHg OR meeting stages 0 (asymptomatic), 1 (mild claudication) and 2 (moderate claudication at 200m) of the Rutherford Classification for peripheral arterial disease
•- Infected ulcers being appropriately managed
•- Ulcers meeting The University of Texas wound classification criteria: A1, A2, A3 (wounds of varying depth without infection or ischaemia) and B1, B2, B3 (wounds of varying depth with infection only)

•- Participants taking immunosuppressive medication
•- Known allergies to wound dressing products
•- Pre-existing ulcer pain preventing either type of debridement
•- Vascular assessment: meeting stages 3 (severe classification), 4 (rest pain), 5 (ischaemic ulceration not exceeding ulcer of the digits of the foot) and 6 (severe ischaemic ulcers or frank gangrene) of the Rutherford Classification for peripheral arterial disease
•- Dry gangrenous ulcers
•- 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 with varying depth and ischaemia only), D1, D2, D3, (wounds with varying depth with ischaemia and infection)

发起方

ucia Michailidis