NCT06690177

Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers

A Multicenter, Prospective, Randomized, Placebo and Collagenase (Non-surgical Standard-of-care) Controlled Study, Performed to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase in Patients With Venous Leg Ulcers

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: MediWound Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is: To assess the safety of EscharEx (EX-03 5% formulation) compared to placebo control and compared to Collagenase (NSSOC) in patients with VLU.

Detailed description

At least 45 eligible adult patients with VLU (with a surface area between 2 cm2 and 25 cm2, and wound age between 4 weeks and 12 months), will be randomized. The patients will be treated with IMP (either EX-03 5% or placebo) in a double blinded manner or with Collagenase in unblinded manner. Total duration of the study is up to 15 weeks: Screening period (2 visits, 7 days apart), Daily Visits Period - Debridement with IMP (up to 8 daily site visits within up to 2 weeks), Weekly Visits Period - wound management (up to 11 visits within up to 10 weeks) + optional wound closure confirmation (up to 2 weeks). Wound will be managed in a standardized manner.

Conditions

• Venus Leg Ulcers

Interventions

Type	Name	Description
DRUG	EscharEx (EX-03)	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.
DRUG	Placebo (Gel vehicle)	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

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-12-30
• Completion: 2028-09-30
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

2 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study