The use of a novel method of measuring blood flow to foot wounds in diabetic patients with aim of predicting wound healing

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Participation will entail answering a questionnaire and undergoing lower limb angiogram in which the Siemens Syngo PBV software will be used. It is important to emphasize that all included patients would undergo angiogram regardless of the study and that the participation on the study will allow the use of Siemens PBV software as adjunct during revascularisation and to have wound photos taken prior to revascularisation and during follow-up appointments. Clinical management, investigations and follow-up will be conducted as per standard of care practices. There is no requirement for additional follow-ups or tests as result of participation in the research. At recruitment Lower limb perfusion will be assessed using toe pressures and/or transcutaneous oxygen pressure and the WIfI classification system will be used to more precisely stratifying patients according to their initial disease burden. These are clinical information that are routinely obtained in the management of patients with diabetic foot ulcers. The WIfI classification was proposed in 2014 by the Society for Vascular Surgery for assessment of treatment limb which is especially applicable of patients with diabetic foot ulcer. The WIfI classification is intended to define the disease burden and allow accurate outcomes assessments and comparisons between similar groups of patients and alternative therapies. The WIfI classification system assesses three key components of a threatened limb (wound, ischemia, and foot infection), each with four grades of severity (none, mild, moderate, and severe) to predict the 1-year risk of amputation and benefit of revascularisation. WoundVue camera will be used for more accurate and reproducible assessment of wounds. It is a hand-held portable device that takes 2D and 3D images of wounds to objectively monitor wound healing. The device algorithms are able to interpret tissue types and automatically provide surface, volume and depth measurement. All participants will undergo an endovascular revascularisation procedure which will be performed by a Vascular Surgeon (Prof Robert Fitridge, Dr Ewan Macaulay, Dr Joseph Dawson, Dr Michael Herbert or Dr Kurian Mylankal) with vast experience in this procedure. The revascularisation aims to restore perfusion to the affected foot and subsequently promote wound healing, help to resolve infection and avoid or limit level of amputation. PBV which indicates the distribution of blood in lesions and surrounding tissue by means of color-coded cross-sectional blood volume maps will be assessed before and after angioplasty/stenting. Data on foot wound status, treatments administered and outcomes (wound healing or amputation) will be collected during follow up visits over 12 months. WoundVue camera will used for more accurate, frequent and reproducible assessment of wound healing. Details of data to be collected are giving in baseline data and follow up data forms

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