Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06568627 | A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE) | PHASE3 | RECRUITING | 216 | — | — | Jun 1, 2025 | Mar 1, 2027 | Apr 2, 2026 | 25 | United States, Austria +3 |
counting events of complete debridement
counting events of complete wound closure until completion of weekly visits
| Arm | Type | Description |
|---|---|---|
| EscharEx (EX-03) | ACTIVE_COMPARATOR | EX-03 is the code name of the third generation of EscharEx investigational medicinal product (IMP) formulation. A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is blended with excipients. EX-03 5% powder, should be diluted with Water for Injection (WFI) prior usage. |
| Placebo | PLACEBO_COMPARATOR | Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API. Placebo powder, should be diluted with Water for Injection (WFI) prior usage. |
| Name | Type | Description |
|---|---|---|
| EscharEx (EX-03) | DRUG | a sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the wound area. |
| Placebo (Gel vehicle) | DRUG | A sterile powder containing excipients only (no proteolytic enzymes). The powder and sterile water are mixed to form a gel prior to application on the wound area |
Inclusion Criteria: 1. Men or women, older than 18 years of age, 2. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency), 3. Wound is present for at least 4 weeks but no longer than 1 year, 4. The adherent nec...