Table 2. Follow-up protocol for CHAMP.
The following tests are performed at baseline: (1) baseline blood tests (CBC, CMP); (2) infectious disease panel; (3) medical history and physical examination; (4) medication history; (5) pregnancy test; (6) 12-lead EKG. Additional noninvasive clinical testing of the ischemic limb includes ankle-brachial index (ABI), toe-brachial index (TBI), transcutaneous oximetry (TcPO2), and SPY-Elite angiography with IV indocyanine (ICA).
| Evaluation | Baseline | MSC Injection | BKA (Day varies) | Day 3 | Day 14 | Day 45 | Week 12 | Week 18 | Week 24 |
|---|---|---|---|---|---|---|---|---|---|
| Informed Consent | X | ||||||||
| Medical History | X | ||||||||
| Physical Exam | X | X | X | X | X | X | X | X | X |
| Vital Signs | X | X | X | X | X | X | X | X | X |
| Medication List | X | X | X | X | X | X | X | X | |
| Serum Pregnancy Test | X | ||||||||
| Adverse Event Evaluation | X | X | X | X | X | X | X | X | X |
| Infectious Disease Labs | X | ||||||||
| General Labs | X | X | X | X | X | X | |||
| 12-Lead EKG | X | X | X | X | X | X | |||
| Lower Extremity Arterial Duplex | X | ||||||||
| Randomization: Time to BKA | X |