The treatment of foot problems in patients with diabetes or reduced blood flow to the legs

This is an observational prospective study which will collect information on healing in diabetic foot disease and critical limb ischaemia across three major centres. There is recruitment consultation, and follow up at 1 month, 3 months, 6 months and 12 months. Recruitment Observational Data At the time of recruitment, we will collect the following data: service details, baseline demographic and clinical history details, wound data on both lower limbs and discharge information. Baseline service details will include the service the participant is attending at the time of recruitment, the date and source of referral to the current service, and all the relevant services/teams that are currently involved with the participant’s management. Baseline demographic and clinical history details will include the participants age in years, gender and the ethnicity that the participant identifies with. The New Zealand (NZ) ethnicity selection will align with NZ census and research standards. In Australia, participants will be asked to identify as Aboriginal or Torres Strait Islander, or non-Aboriginal/Torres Strait Islander. In addition, the history of diabetes mellitus will be collected including whether the participant has been diagnosed with diabetes, the year of diabetes diagnosis, the type of diabetes the participant is diagnosed with, current glycaemic control with a HbA1c dated within the last 3 months. Adjustments will later be made for differing of HbA1c reporting between Australia (%) and New Zealand (mol/mmol). Other baseline health status data collection will include recent haemoglobin level and date, presence of transfusion of red blood cells in last 3 months, current dialysis status for renal replacement therapy and dialysis modality, recent eGFR and creatinine, smoking history listed as current, ex-smoker less than 12 months, ex-smoker greater than 12 months or non-smoker; and number of smoking pack years (number of packs of cigarettes smoked per day by the number of years the participant has smoked), concomitant medications that the participant is currently taking. The presence of vascular risk factors will be noted including a family or personal history of ischaemic heart disease, cerebrovascular accident or peripheral artery disease, hypertension, hypercholesterolaemia, presence of lipid lowering medications, diabetes, and smoking history. In addition, the height (m) and weight (kg) to calculate BMI, most recent vitamin A, vitamin C, vitamin D, zinc, ferritin and vitamin B12 levels, the average grip strength out of three attempts for both hands using a dynamometer, and the Clinical Frailty Scale (1-9) produced by Geriatric Medicine Research, Dalhousie University, Canada will be recorded. Also collected will be whether the participant is currently admitted to hospital, recently discharge in the last 1 month with duration of stay or whether admission is required from this review, and any recent vascular or diabetic foot disease related interventions in the past 6 weeks, including the name the intervention, date and angioplasty or lower limb bypass occurred, the details of which vessels were involved in the treatment. Baseline wound data will be collected on both lower limbs (including contralateral asymptomatic limbs) including presence of peripheral neuropathy based on a 10g monofilament examination, palpable dorsal pedis or posterior tibial pulses, the Pedal Acceleration Time (PAT) in milliseconds for both legs via ultrasound examination and date. The foot arteries able to be examined in PAT are the arcuate artery, dorsal metatarsal artery, medial plantar artery, lateral plantar artery and deep plantar artery. The toe pressure and toe pressure location (great toe or second toe) will be recorded. If the toe pressure is not attainable, the reason for a lack of toe pressure reading, such as multiple toe amputation, forefoot amputation, callus, significant oedema, or very poor perfusion will be recorded. The inability to obtain a toe pressure with damped or monophonic waveforms will layer be scored in severe ischaemia category (i=3) on Wound, Ischaemia, Foot Infection (WIfI) assuming “very poor perfusion” as the cause. The reports of imaging in past 6 months including foot x-ray, arterial lower limb duplex ultrasound, computerised tomography (CT), magnetic resonance imaging (MRI) or digital subtraction angiography (DSA); and whether surgical revascularisation has occurred since the imaging will be recorded. The current target artery path (TAP) status will be collected. An intact TAP is defined as there being <50% stenosis in the iliac/femoral arteries with at least 1 vessel run off to the foot; and intact if there is a >50% stenosis in the iliac/femoral arteries and/or there is no vessel run off to the foot. In addition, whether the participant has undergone a minor or major limb amputation in the past, time since amputation and site of site of the amputation will be recorded; along with whether the participant has a past history of ulceration on each foot, the current presence of rest pain, foot ulceration or gangrene. One wound will be chosen on each foot to be the “index” wound. This will be determined as the highest grade wound on the foot as determined by wound criteria in the WIfI scoring. The index wound type being surgical wound, ulcer or gangrene will be collected. A surgical wound is described as a wound created by a surgical procedure such as debridement or amputation, an ulcer being a tissue deficit not surgically created and gangrene as necrosis of tissue. A wound labelled ulcer or gangrene may change to a surgical wound if a surgical debridement or amputation takes place. However, once labelled a surgical wound, the wound shall remain labelled surgical wound until healed. The location, depth and duration in weeks of the index surgical wound, ulcer or gangrene will be collected utilising patient recall and medical records, followed by a description of all foot wounds, ulcer(s) or gangrene and size (mm2) using a wound measurement device to measure the collective size surgical wounds and ulcers. If the index is a surgical wound, the duration of ulcer or gangrene prior to the first debridement or amputation in weeks will be collected. The depth will be defined as superficial , deep or extensive ulcer based on wound criteria for depth in WIfI scoring. Also recorded will be the highest CRP within the last two weeks and date, details of current antimicrobial therapy including antibiotic prescribed and duration of therapy, recent microbiology results relevant to the limb ulcer or wound, sensitivities and date. A wound ,ischaemia, and foot infection grade based on WIfI for each limb will be recorded and used to calculate the WIfI score for amputation risk at one year and benefit of revascularisation. The current offloading measures defined as no offloading, removable ankle (or knee) high device, therapeutic footwear, and surgical offloading. Baseline discharge information will record the service discharge destination including diabetic foot clinic, GP, acute hospital admission, waitlist for surgery, palliative care, residential aged care series or patient discharged self at risk. Review Observational Data Participants will be reviewed at 1, 3, 6 and 12 months during the one year follow up occurring at subsequent clinic appointments or hospital admissions. Unless italicised, data collected in the review consultation has the same definition as the recruitment information. Review service details will include the service attended, and all the relevant services/teams currently involved in management. Review demographic and clinical history details will include diabetes diagnosis, HbA1c dated within the last 3 months, recent haemoglobin level and date, blood transfusion in last 3 months, grip strength and the Clinical Frailty Scale (1-9). Also, whether the participant is currently admitted to hospital, recent discharge since last review with duration of stay or admission required from this review; and any recent vascular or diabetic foot disease related interventions since last review. Review wound data will be presence of palpable pedal pulses, recent PAT and date, toe pressure, toe pressure location and reason for a lack of toe pressure reading. Recent imaging reports since last review, whether surgical revascularisation has occurred since the imaging and the TAP status. The current presence of rest pain, foot ulceration or gangrene will be collected. The index wound type, location, depth and duration will be recorded, followed by a description of all foot wounds, ulcer(s) or gangrene and size (mm2). If the index is now a surgical wound, the duration of ulcer or gangrene prior to the first debridement or amputation in weeks will be collected. The highest CRP within the last two weeks and date, details of current antimicrobial therapy, recent microbiology results relevant to the limb ulcer or wound, sensitivities and date. The WIfI grades and WIfI score for amputation risk at one year and benefit of revascularisation will be recorded. The current offloading measures will be recorded. Review discharge information will record the service discharge destination and the outcomes of whether the right or left foot index wound has healed defined as complete re-epithelisation of the previous tissue defect and date of healing; whether a right or left major limb amputation has occurred defined as the removal of a limb above the ankle and date; whether the participant has died and date of death.