Table 3 Baseline data: arterial assessment

Known peripheral arterial disease and/or history of lower extremity revascularisation procedure

N/A

Medical record review.

History of peripheral arterial disease and/or lower extremity revascularisation procedure documented in medical records.

Pedal pulses

N/A

• Physical palpation of the dorsalis pedis and posterior tibial pulses on both feet with the examiners fingers (4 pulses in total) [52]

Absence of ≥2 pedal pulses will indicate peripheral arterial disease [52].

• Pedal pulses will be recorded as ‘present’ or ‘absent’

Toe-brachial pressure index

SysToe® (Atys Medical, Soucieu-en-Jarrest, France).

• Toe pressure measurement will be performed prior to the ankle pressure measurement to ensure arterial supply to the toes is not affected

Toe-brachial pressure index ≤0.6 will indicate peripheral arterial disease [44, 45, 53].

• Room temperature (minimum 21–23 ± 1° C) to prevent vasoconstriction of digital arteries [92]

• Participants will be rested for a minimum of 15 min prior to assessment

• Participants to avoid use of tobacco and consumption of coffee for at least one hour prior to assessment [92, 93]

• Pneumatic cuff (120 x 25 mm) is placed on the proximal phalanx of hallux (i.e. proximal cuff) [47, 48]

Note: If hallux is absent, a 90 x 15 mm digital cuff will be used on the second toe [48, 49].

• Double-sided tape is applied to sensor [47]

• Sensor is positioned on the plantar aspect of the hallux (or second toe) and secured with another pneumatic cuff (i.e. distal cuff) [47, 48]

• Turning the SysToe® device on will cause an automated sequence involving inflation of the distal cuff, then inflation of the proximal cuff, followed by rapid deflation of the distal cuff and slower deflation of the proximal cuff (3 mm Hg s⁻¹) [47, 48]

• The return of blood perfusion (measured by the proximal cuff) will be recorded as the toe systolic pressure [47, 48]

• Toe pressure assessment is repeated for contralateral side (if appropriate)

• Toe-brachial pressure index value is calculated by dividing the toe systolic pressure by the highest (or available) brachial systolic pressure

• Toe brachial pressure index value calculated separately for left and right lower limbs

Note: Brachial systolic pressures obtained in the ankle-brachial pressure index assessment will be used to calculate the toe-brachial pressure index value.

Ankle-brachial pressure index

Hadeco Bidop ES100V3 Bi-Directional Doppler Complete with LCD Display and 8 MHz Probe.

• Room temperature (minimum 21–23 ± 1° C) to prevent vasoconstriction of digital arteries [92]

Ankle-brachial pressure index ≤0.9 will indicate peripheral arterial disease [44, 45, 53, 54].

Erka® ‘Switch’ Sphygmomanometer and cuff.

• Participants will be rested for a minimum of 15 min prior to assessment

Ankle-brachial pressure index >1.3 or non-compressible arteries (i.e. >240 mm Hg) will indicate arterial calcification [44, 54].

• Participants to avoid use of tobacco and consumption of coffee for at least one hour prior to assessment [92, 93]

• Brachial cuff is applied 3 cm above the cubital fossa

• Brachial pulse located via palpation

• Doppler ultrasound conducting gel is applied to the skin [92]

• Doppler probe is applied at a 45° angle to the skin [92], in the direction of the arterial blood flow

• Cuff is inflated to 20–30 mm Hg beyond the last audible signal and then slowly deflated until the audible signal returns [92]

• Repeated for contralateral side (if appropriate)

• Brachial systolic pressure(s) recorded

Note: In the case of an arteriovenous fistula (i.e. vascular access for haemodialysis treatment) the brachial systolic pressure will be measured from the arm free of the fistula [45].

• Ankle cuff is applied 3 cm above the medial malleolus

• Dorsalis pedis and posterior tibial pulses are located via palpation

• Doppler ultrasound conducting gel is applied to the skin [92]

• Doppler probe is applied at a 45° angle to the skin [92], in the direction of the arterial blood flow

• Cuff is inflated to 20–30 mm Hg beyond the last audible signal and then slowly deflated until the audible signal returns [92] (maximum 240 mm Hg). Process is repeated for both the dorsalis pedis and posterior tibial pulses

• Repeated for contralateral side (if appropriate).

• The highest of the two systolic pressure values obtained from the dorsalis pedis and posterior tibial pulses will be recorded [92]

Note: If the pressure needs to be repeated, the examiner will wait one minute before re-inflating the cuff [92].

• Ankle-brachial pressure index value is calculated by dividing the highest ankle systolic pressure (i.e. highest value between dorsalis pedis and posterior tibial pulses) by the highest (or available) brachial systolic pressure

Note: Ankle-brachial pressure index value is calculated separately for left and right lower limbs.