Demography
|
X
| | | | | | | | | | | |
Medical History
|
Physical Exam
|
X
| |
X
|
X
| |
X
|
X
|
X
| | | |
X
|
Concomitant Meds
|
Anticoagulant/antiplatelet therapy
|
X1
|
X2
|
X
|
X
| | | | | | | | |
Informed Consent
|
X
| | | | | | | | | | | |
Incl/Excl Evaluation
|
X
|
X
| | | | | | | | | | |
Routine Lab testing (see Table 2)
|
X3
| |
X
|
X
| |
X
|
X
|
X
| | | |
X
|
Ankle pressure, toe pressure, TcPO2, PVR (at least 1 required) and brachial pressure
|
X3
| |
X
|
X
| |
X
|
X
|
X
| | | |
X
|
Wound assessment7 and Wound Care
|
X
| |
X8
|
X
| |
X
|
X
|
X
| | | |
X
|
Rutherford Staging
|
X
| | |
X
| |
X
|
X
|
X
| | | |
X
|
EQ5D
|
X3
| | | | |
X
|
X
|
X
| | | |
X
|
WIQ
| | | | | |
X
|
X
|
X
| | | |
X
|
Angiography
|
X3
|
X
| | | | |
X4
| | | | |
X5
|
Hospital FU Visits
| | | |
X
| |
X
|
X
|
X
| | | | |
Telephone FU
| | | | |
X
| | | |
X
|
X
|
X
| |
Adverse Event Assessment
| |
X
|
X
|
X
|
X6
|
X
|
X
|
X
|
X6
|
X6
|
X6
|
X
|