An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg Ulcers

NCT07692178 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MW2022-04-14
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a pharmacokinetics (PK) study - the main objective of this study is to assess the PK, safety and clinical performance of 5% EscharEx (EX-03 formulation) in debridement of Venous Leg Ulcers

Conditions

Venous Leg Ulcer (VLU)

Keywords

VLU; EscharEx; Debridement; Wound bed preparation

Outcome Measures

Primary Outcomes (3)

• PK Evaluation

  Cmax (maximal observed serum concentration),

  Up to 2 weeks

• Safety and Tolerability Endpoints

  Incidence and severity of systemic and local adverse events (AEs),

  up to 5 weeks

• PK Evaluation

  AUC (area under the concentration -time curve)

  Up to 2 weeks

Secondary Outcomes (2)

• Incidence of complete debridement, clinically (visually) assessed after each application during the Daily Visits Period (up to 8 applications)

  up to 2 weeks

• Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically

  up to 2 weeks

Study Arms (1)

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.

Drug: EX-03

Interventions

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 w

Also known as: Gel vehicle, 5% EscharEx, EX-03 formulation

EscharEx (EX-03)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women, older than 18 years of age,
• Participants with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),
• Wound is present for at least 4 weeks but no longer than 2 years,
• The adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and either sterile saline or water and mild soap, is at least 50% of the wound area (assessed by clinical evaluation),
• Target wound surface area is in the range of 10-80 cm2 (assessed by eKare inSightTM),
• Participants understand the nature of the procedure, is able to adhere to the protocol regimen, and provides written informed consent prior to any study procedure.

You may not qualify if:

• Wound size that has decreased by \> 20% after 7 (+3/-1) days of the screening period,
• Participants with more than one leg ulcer , on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2 cm and 5 cm away from the edge of the target wound,
• Severely damaged skin (e.g., abrasion, erosion, exfoliation) extending \>2 cm around the wound's edge,
• Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,
• Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during the screening phase,
• Clinical suspicion of skin cancer (e.g., basal cell carcinoma (BCC), squamous cell carcinoma (SCC), melanoma, or sarcoma), near the target wound, which was not ruled out by biopsy,
• Participants with skin disorders unrelated to the wound that are present adjacent to the wound,
• Participants suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma Gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,
• Wound has sinus tracts or tunnels extending under healthy tissue, or penetrating into periosteum, fascia or bone,
• Participants with primary lymphatic edema (lymphedema),
• A significant decrease in the arterial blood flow of the extremity, as demonstrated by either Toe-Brachial Index (TBI) ≤ 0.50, Ankle-Brachial Index (ABI) ≤ 0.70, Skin Perfusion Pressure (SPP) ≤ 40 mmHg, Transcutaneous oximetry (TCOM) ≤ 40 mmHg, or lack of bi-phasic or tri-phasic doppler wave forms,
• Participants with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e. pseudoeschar as a result of SSD treatment),
• History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,
• Participants with poor nutritional status: albumin \< 2.5g/dl, poorly controlled Diabetes Mellitus (for diabetic participants; HbA1c \> 12%), anemia (hemoglobin\<8 g/dL), a leukocyte counts \< 3,000/μl or \>15000/μl, platelets \<100,000/μl, abnormal liver function (AST, ALT\>2 x upper limit of normal range), renal failure (Cr \> 2.5 mg/d or eGFR \< 30ml/min /1.73m2l ), BMI\>48,
• INR\>2 or PTT \> x 2 ULN (unless the patient receives coumarin derivatives anticoagulants (e.g. warfarin), and the INR and PTT levels are in their required levels and are stable),

Sponsors & Collaborators

• MediWound Ltd: lead
• TFS HealthScience: collaborator

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Gels

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Shelly Vander

CONTACT

+972-523527960; shellyv@mediwound.com

Vered Sasson

CONTACT

+972-546145559; vereds@mediwound.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open label, single treatment, single arm, multiple dose study

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share