Venous Leg Ulcer (VLU)Phase 2NCT07692178
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
A Phase 2 study testing EX-03 in people with Venous Leg Ulcer (VLU), run by MediWound Ltd.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer (VLU)
- What is being tested?
- EX-03
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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),
- Participants undergoing renal or peritoneal dialysis,
- Any known condition that would preclude safe participation in the study, e.g., significant or unstable cardiac, vascular, pulmonary, liver, hematological, infectious, immunological, neoplastic disease, or any immediate life-threatening condition,
- Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion,
- The Patient is currently receiving, or has received within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments known to affect the wound healing processes; these include chronic systemic steroid intake or chronic systemic steroid intake with topical skin changes (i.e. thin, fragile skin with multiple hematomas or previous laceration history), immuno-suppressive drugs, immunomodulating medications, chemotherapy, and radiation therapy. Low and intermittent doses that the investigator determines as not clinically significant for wound healing, may be permitted, provided that this determination is based on appropriate clinical judgment and is documented accordingly,
- Participants treated with Pentoxifylline within 2 weeks prior to screening,
- Venous ablation performed within the past month in an area adjacent to the target wound,
- Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric participants, etc.),
- Concurrent use of non-approved drugs or alcohol abuse,
- Pregnant women (positive pregnancy test) or nursing mothers
- Exposure to investigational intervention within one month prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the detailed description
Approximately 20 eligible adult participants with VLU (with a surface area between 10 cm2 and 80 cm2, and wound age between 4 weeks and 2 Years), will be enrolled. The participants will be treated with EX-03 5%.
Each participant will go through 3 periods during the trial:
- Screening period (2 visits, 7 (+3/-1) days apart),
- Daily visits period (up to 8 daily site visits within up to 14 days), During the Daily visits period, Blood will be drawn for PK analysis before and after EscharEx application (i.e. during debridement treatment).
PK sampling will be obtained during and following applications of treatment at time points relative to the first application.
- Weekly visits period (2 visits within 14 days), The overall duration of the study for a patient will be up to 5 weeks.
- Conditions
- Venous Leg Ulcer (VLU)
- Being tested
- EX-03
- Keywords
- VLU, EscharEx, Debridement, Wound bed preparation
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EX-03Drug
Also called Gel vehicle, 5% EscharEx, EX-03 formulation
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: EX-03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Evaluation
Cmax (maximal observed serum concentration),
Measured: Up to 2 weeks
Safety and Tolerability Endpoints
Incidence and severity of systemic and local adverse events (AEs),
Measured: up to 5 weeks
PK Evaluation
AUC (area under the concentration -time curve)
Measured: 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)
counting events of complete debridement
Measured: up to 2 weeks
Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically
counting events of complete granulation
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open label, single treatment, single arm, multiple dose study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS HealthScience
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692178
- Sponsor's protocol ID
- MW2022-04-14
- Status last verified
- Jul 2026
- First submitted
- 4 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07692178
- Acronym / sponsor ID
- MW2022-04-14
- Conditions
- Venous Leg Ulcer (VLU)
- Keywords
- VLU, EscharEx, Debridement, Wound bed preparation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- Collaborators
- TFS HealthScience
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Approximately 20 eligible adult participants with VLU (with a surface area between 10 cm2 and 80 cm2, and wound age between 4 weeks and 2 Years), will be enrolled. The participants will be treated with EX-03 5%.
Each participant will go through 3 periods during the trial:
- Screening period (2 visits, 7 (+3/-1) days apart),
- Daily visits period (up to 8 daily site visits within up to 14 days), During the Daily visits period, Blood will be drawn for PK analysis before and after EscharEx application (i.e. during debridement treatment).
PK sampling will be obtained during and following applications of treatment at time points relative to the first application.
- Weekly visits period (2 visits within 14 days), The overall duration of the study for a patient will be up to 5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open label, single treatment, single arm, multiple dose study
| Arm | Type | Receives |
|---|---|---|
| EscharEx (EX-03) | Active comparator | Drug: EX-03EX-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (25 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EX-03Also: Gel vehicle, 5% EscharEx, EX-03 formulationa 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 | Drug | EscharEx (EX-03) |
Primary outcome
PK Evaluation
Time frame: Up to 2 weeks
Cmax (maximal observed serum concentration),
Safety and Tolerability Endpoints
Time frame: up to 5 weeks
Incidence and severity of systemic and local adverse events (AEs),
PK Evaluation
Time frame: Up to 2 weeks
AUC (area under the concentration -time curve)
2 secondary outcomes
Incidence of complete debridement, clinically (visually) assessed after each application during the Daily Visits Period (up to 8 applications)
Time frame: up to 2 weeks
Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically
Time frame: up to 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Venous Leg Ulcer (VLU)
Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Recruiting
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Venous Leg Ulcer (VLU), Venous Hypertension Ulcers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EX-03 in people with Venous Leg Ulcer (VLU), run by MediWound Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shelly Vander (+972-523527960, shellyv@mediwound.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK Evaluation (time frame: Up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.