Table 3.
Details of the study-related information, clinical assessment, and laboratory tests planned to be obtained at different visits of the study participants.
|
|
Baseline visit 1—day 0 | Visit 2—day 14 | Visit 3—day 28 | Visit 4; EOTa—day 42 | Visits 5 and 6—2 and 4 mo after EOT | Visit 7; test of cure—6 mo after EOT |
| Radiograph, MRIb, ESRc, and CRPd | ✓ |
|
|
✓ |
|
✓ |
| Inclusion and exclusion criteria | ✓ |
|
|
|
|
|
| Informed consent | ✓ |
|
|
|
|
|
| Demographics | ✓ |
|
|
|
|
|
| Medical history | ✓ |
|
|
|
|
✓ |
| Neuropathy and vascular assessment | ✓ |
|
|
|
|
|
| Clinical assessment of infection | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Culture and sensitivity tests | ✓ |
|
|
|
|
|
| Control of compliance |
|
✓ | ✓ | ✓ |
|
|
| Adverse events |
|
✓ | ✓ | ✓ |
|
|
| Renal, hepatic, and hematologic parameters | ✓ |
|
✓ | ✓ |
|
|
aEOT: end of trial.
bMRI: magnetic resonance imaging.
cESR: erythrocyte sedimentation rate.
dCRP: C-reactive protein.