Assessing the feasibility and accuracy of a novel point of care test to predict foot ulcer healing in people with diabetes

Royal Prince Alfred Hospital0 个研究点目标入组 50 人开始时间: 2024年3月21日最近更新: 2024年3月25日

适应症

试验速览

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•Type 1 or type 2 diabetes and a diabetes-related foot ulcer of greater than 2 weeks duration
•- Male and female
•- Age 18 years and above (nil limit)
•- Willingness to provide informed consent and willingness to participate and comply with the study requirements including standard care; pressure offloading, sharp debridement, weekly or second weekly clinic visits attending the Interdisciplinary High Risk Foot Service of the Diabetes Centre, Department of Endocrinology, at Royal Prince Alfred Hospital or Concord Hospital
•- Participants can be recruited when perfusion restored and/or infection controlled where present

•- Ulcer depth to bone
•- Major limb ischaemia with ABPI < 0.6 or Toe pressure <40mm Hg in at least one foot artery in the affected foot
•- Moderate (cellulitis) or severe (requiring hospitalisation) bacterial infection
•- Duration of greater than 3 months (at the treating centre)
•- Wounds are less than 0.5cm2
•- Participants will be excluded from REVITA treatment if they have failed to attend 2 or more visits in the proceeding 4 weeks or if they have attended 2 or more clinic visits without wearing their pressure offloading or have self-reported less than 80% adherence to wearing pressure offloading. Thus they will be excluded from receiving Revita® if they have not received optimal interdisciplinary High Risk Foot Service care.

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