Table 2:
Procedures | S | R | W 1 |
W 2 |
W 3 |
Month 3 |
W 14 |
W 15 |
W 16 |
Month 6 |
Month 9 |
---|---|---|---|---|---|---|---|---|---|---|---|
History, physical | X | X | X | X | X | X | X | X | X | X | X |
Blood Tests | |||||||||||
CBC and Chemistry | X | X | X | X | X | X | X | X | X | X | X |
Progenitor cells | X | X | X | X | X | X | |||||
Functional measures | |||||||||||
Treadmill exercise test | X | 2X | 2X | 2X | 2X | ||||||
6-minute walk test | X | 2X | 2X | 2X | 2X | ||||||
ABI | X | X | X | X | X | ||||||
Questionnaires | |||||||||||
San Diego | X | ||||||||||
SF-36 survey | X | X | X | X | |||||||
WIQ | X | X | X | X | |||||||
Adverse Effects/Events | X | X | X | X | X | X | X | X | X |
Abbreviations: S = screening visit, R = randomization visit, W = week, CBC = complete blood count, ABI = ankle brachial index, SF = short-from, WIQ = walking impairment questionnaire