Table 5.
Changes in Physical Examination Findings from Screening Visit
| Subject1 | Organ System | Visit at | Specification |
|---|---|---|---|
| 1 | Extremities | Week 12 | Oedema lower legs significantly reduced |
| Skin | Week 12 | Target ulcer almost closed, newly occurred nontarget ulcer | |
| 2 | Extremities | Week 12 | Ulcer left leg closed |
| Head | Week 12 | Scar occipital | |
| 3 | Skin | Week 6.12 | Skin irritation left lower leg |
| 4 | Skin | Week 6.12 | Plaster allergy left lower leg3 |
| 5 | Skin | Week 6.12 | Scar from carpal tunnel surgery |
| Skin | Week 12 | Pruritus4 | |
| 6 | Skin | Week 12 | Target ulcer and nontarget ulcers smaller |
| 7 | Skin | Week 12 | Clavus left hallux5 |
| 8 | Skin | Week 12 | Target ulcer closed |
| 9 | Skin | Week 6.12 | Intertrigo at the right mamma6 |
| 10 | Skin | Week 12 | Stasis dermatitis at the right foot/ankle7 |
| 11 | Ears | Week 6.12 | Disorder of the tuba auditiva |
Abbreviation: TEAE, treatment-emergent adverse event.
These changes are reported for the safety analysis set (n = 31).
Subjects presenting with changes in physical examinations; they are numbered consecutively.
Week 6.1: this visit was intended for the second cell application, scheduled 1–5 days after the week-6 efficacy follow-up visit.
Documented as TEAE (allergic contact dermatitis) not related to study treatment.
Documented as TEAE (pruritus) not related to study treatment.
Documented as TEAE (hyperkeratosis) not related to study treatment.
Documented as TEAE (allergic contact dermatitis) not related to study treatment.
Documented as TEAE (stasis dermatitis) not related to study treatment.