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

Conditions

• Venous Leg Ulcer (VLU)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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).

Key Dates

Start date

Jun 1, 2025

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

216 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: EscharEx (EX-03)
  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 Comparator: Placebo
  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.

Primary Outcome Measure

Incidence of complete debridement, clinically (visually) assessed after each application [ Time Frame: up to 2 weeks ]

Central Contacts

• Yael Katz-levy, Ph.D.
  +972-546774149
  [email protected]
• Aya Ben-Yaakov, Ph.D
  +972-508814005
  [email protected]

Locations (14)

Find similar trials in Fresno, CA

Related Studies

• Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
  PHASE4 · Recruiting · AOTI Ltd. · New York, New York
• A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
  PHASE4 · Recruiting · HealthTech Wound Care · DeLand, Florida
• EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD
  Not Yet Recruiting · Laboratoires URGO · New York, New York
• Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
  PHASE4 · Recruiting · Kerecis Ltd. · Monroeville, Pennsylvania