Table 1.
Patient characteristics, study disposition, and wound healing over time: all treated patients*
| Patient Number | Age, y | Gender | Baseline Wound Size, cm | Wound Location | Necrotic Baseline, % | Necrotic Day 14, % | Necrotic Day 28, % | Time to Healing (Days) or Other Outcome |
|---|---|---|---|---|---|---|---|---|
| Patients completing the study (n = 15) | ||||||||
| 13 | 43 | F | 1.2 × 0.9 | Rt hallux | 15 | – | – | 9 |
| 20 | 61 | F | 1.5 × 1.5 | Rt plantar | 40 | – | – | 9 |
| 9 | 60 | F | 1.2 × 2.0 | Rt plantar | 20 | – | – | 12 |
| 18 | 67 | M | 1.4 × 1.8 | Lt forefoot | 15 | 0† | – | 15 |
| 2 | 45 | F | 1.2 × 1.5 | Lt hallux | 80 | 5 | – | 19 |
| 4 | 81 | M | 2.1 × 2.2 | Lt hallux | 70 | 40 | – | 26 |
| 8 | 53 | F | 1.6 × 2.2 | Lt midfoot | 40 | 40 | 20 | 32 |
| 1 | 65 | F | 4.9 × 2.8 | Rt heel | 60 | 20 | 9 | 35 |
| 11 | 64 | M | 1.0 × 1.0 | Lt plantar | 50 | 25 | 0 | 35 |
| 16 | 64 | F | 4.5 × 1.0 | Lt heel | 25 | 10 | 10 | 35 |
| 3 | 71 | M | 2.1 × 1.4 | Rt heel | 30 | 5 | 0 | 40 |
| 7 | 72 | M | 2.6 × 3.1 | Lt heel | 98 | 30 | 15 | 65 |
| 5 | 49 | M | 2.7 × 4.1 | Lt midfoot | 50 | 25 | 20 | 113 |
| 6 | 57 | F | 1.7 × 1.0 | Rt midfoot | 90 | 70 | 20 | 124 |
| 17 | 64 | M | 5.0 × 7.0 | Lt heel | 100 | 95 | 80‡ | Did not heal after 135 days |
| Patients discontinuing from the study (n = 4) | ||||||||
| 12 | 65 | F | 2.0 × 1.3 | Rt plantar | 90 | – | – | Withdrew after 12 days due to an SAE of cellulites |
| 14 | 72 | F | 1.0 × 1.0 | Rt plantar | 50 | 90 | – | Withdrew after 21 days due to lack of progress |
| 15 | 74 | M | 2.4 × 2.0 | Lt dorsal | 95 | 50 | 25 | Withdrew after 40 days to pursue other treatment options |
| 19 | 64 | F | 5.5 × 3.7 | Rt heel | 100 | 85 | 95 | Withdrew after 40 days of NPWT |
*– indicates healed or withdrew prior to this visit; F, female; ID, identification; lt, left; M, male; NPWT, negative pressure wound therapy; rt, right; SAE, serious adverse event.
†Measured on day 15.
‡Measured on day 29.