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01-12-2014 | Study protocol | Uitgave 1/2014 Open Access

Journal of Foot and Ankle Research 1/2014

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

Journal of Foot and Ankle Research > Uitgave 1/2014
Lucia Michailidis, Cylie M Williams, Shan M Bergin, Terry P Haines
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Electronic supplementary material

The online version of this article (doi:10.​1186/​1757-1146-7-1) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare no competing interests.

Authors’ contributions

All the authors contributed to study design and methodology. LM and CW obtained funding for the study. All authors contributed to the study protocol. LM is the chief investigator and drafted the paper. SB, TH, and CW provided editorial assistance. All authors have read and approved of the final paper.



Foot ulceration has been reported as the leading cause of hospital admission and amputation in individuals with diabetes. Diabetes-related foot ulcers require multidisciplinary management and best practice care, including debridement, offloading, dressings, management of infection, modified footwear and management of extrinsic factors.
Ulcer debridement is a commonly applied management approach involving removal of non-viable tissue from the ulcer bed. Different methods of debridement have been reported in the literature including autolytic debridement via moist wound healing, mechanical debridement utilising wet to dry dressings, theatre based sharps debridement, biological debridement, non-surgical sharps debridement and newer technology such as low frequency ultrasonic debridement.


People with diabetes and a foot ulcer, referred to and treated by the Podiatry Department at Monash Health and who meet the inclusion criteria will be invited to participate in this randomised controlled trial. Participants will be randomly and equally allocated to either the non-surgical sharps debridement (control) or low frequency ultrasonic debridement (intervention) group (n = 322 ulcers/n = 108 participants).
Where participants have more than one ulcer, only the participant will be randomised, not the ulcer. An investigator not involved in participant recruitment or assessment will be responsible for preparing the random allocation sequence and envelopes.
Each participant will receive weekly treatment for six months including best practice podiatric management. Each ulcer will be measured on a weekly basis by calculating total area in centimetres squared. Measurement will be undertaken by a trained research assistant to ensure outcomes are blinded from the treating podiatrist. Another member of the research team will assess the final primary outcome.


The primary aim of this study is to compare healing rates for diabetes-related foot ulcers using non-surgical sharps debridement versus low frequency ultrasonic debridement over a six month period. The primary outcome measure for this study is the proportion of ulcers healed by the six month follow-up period.
Secondary outcomes will include a quality of life measure, assessment of pain and health care resource use between the two treatment modalities.

Trial registration

Australian New Zealand Clinical Trial Registry: ACTRN12612000490​875.

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