NCT06568627

A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)

A Multicenter, Prospective, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of Venous Leg Ulcers (VALUE)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (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 efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).

Detailed description

At least 216 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. Total duration of the study is up to 29 weeks: 1. Screening period (2 visits, 7 days apart), 2. Daily Visits Period - Debridement with IMP (up to 8 daily site visits within up to 2 weeks), 3. Weekly Visits Period - wound management (up to 13 visits within up to 12 weeks) + optional wound closure confirmation (up to 2 weeks). Wound will be managed in a standardized manner. 4. Monthly Visits Period - Wound Closure Durability Period of 12 weeks starting after wound closure confirmation (3 visits within 12 weeks) performed for all wounds.

Conditions

• Venous Leg Ulcer (VLU)

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: 2025-06-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2024-08-23
• Last updated: 2026-04-02

Locations

25 sites across 5 countries: United States, Austria, Germany, Israel, Poland

Regulatory

• FDA-regulated drug study