i)Toe Brachial Index (TBI) equal to or greater than 0.50 or, ii)TBI is not available (toe is absent, wounds are present, or investigative site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g duplex imaging or normal pulse volume recording)