Clinical outcomes, adverse events, and voluntary withdrawals
| Outcomes . | Standard therapy . | Enhanced therapy . | Structured foot examination . |
|---|---|---|---|
| n | 58 | 59 | 56 |
| Patients who contacted study nurse after self-examination | 18 (31.0) | 31 (52.5) | 17 (30.4) |
| Foot ulceration | 17 (29.3) | 5 (8.5) | 17 (30.4) |
| Withdrawal from study because of adverse events | |||
| Foot trauma | 1 (1.7) | 1 (1.7) | 0 |
| Fracture | 0 | 1 (1.7) | 2 (3.6) |
| Death | 2 (3.4) | 1 (1.7) | 0 |
| Osteomyelitis: no ulcer | 0 | 0 | 1 (1.8) |
| Motor vehicle accident | 0 | 0 | 1 (1.8) |
| Myocardial infarction | 0 | 1 (1.7) | 0 |
| Voluntary withdrawal from study | |||
| Too much to do | 2 (3.4) | 6 (10.2) | 2 (3.6) |
| Moved out of town | 1 (1.7) | 0 | 0 |
| Outcomes . | Standard therapy . | Enhanced therapy . | Structured foot examination . |
|---|---|---|---|
| n | 58 | 59 | 56 |
| Patients who contacted study nurse after self-examination | 18 (31.0) | 31 (52.5) | 17 (30.4) |
| Foot ulceration | 17 (29.3) | 5 (8.5) | 17 (30.4) |
| Withdrawal from study because of adverse events | |||
| Foot trauma | 1 (1.7) | 1 (1.7) | 0 |
| Fracture | 0 | 1 (1.7) | 2 (3.6) |
| Death | 2 (3.4) | 1 (1.7) | 0 |
| Osteomyelitis: no ulcer | 0 | 0 | 1 (1.8) |
| Motor vehicle accident | 0 | 0 | 1 (1.8) |
| Myocardial infarction | 0 | 1 (1.7) | 0 |
| Voluntary withdrawal from study | |||
| Too much to do | 2 (3.4) | 6 (10.2) | 2 (3.6) |
| Moved out of town | 1 (1.7) | 0 | 0 |
Data are n (%).