Venus Leg UlcersPhase 2H2HNCT06690177
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)
A Phase 2 study testing EscharEx (EX-03) in people with Venus Leg Ulcers, run by MediWound Ltd at 2 sites in 2 countries.
Trial summary
The objectives of this study are: To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to non-surgical standard of care (NSSOC) To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo control and compared to NSSOC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venus Leg Ulcers
- What is being tested?
- EscharEx (EX-03)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jan 2027to 16 Jan 2029
- 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
- Criteria:
- Men or women, older than 18 years of age,
- Participants with 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 18 months
- The adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and 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 2-40 cm2 (assessed by eKare inSightTM),
- Participant understands the nature of the procedure, is able to adhere to the
Who cannot join
- Wound size decreased by >20% after 7 (+3/-1) days of the screening period,
- Participants with more than one leg ulcer8, 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,
- Signs of infection of the wound or peri-wound including purulent discharge, deep-tissue abscess, cellulitis, erysipelas, etc.,
- Severely damaged skin (e.g., abrasion, erosion, exfoliation) extending >2 cm around the wound's edge,
- Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis,
- 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-enrollment wounds which are covered by eschar heavily saturated with iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e., pseudoeschar because of SSD treatment),
- History of allergy or atopic disease or a known sensitivity to pineapples, bromelain, papaya 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 (HbA1c > 12%); anemia (hemoglobin <8 g/dL), leukocyte count < 3,000/μl or >15,000/μl; neutrophil count ≤1,000/μl; platelets <100,000/μl, abnormal liver function (AST, ALT>2 x upper limit of normal range), renal failure (Cr > 2.5 mg/dl or eGFR < 30ml/min /1.73m2), BMI>48,
- INR>2 or PTT> x2 ULN (unless the participant 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 cardiovascular, pulmonary, liver, hematological, immunological, neoplastic disease or any immediate life-threatening condition,
- Recent history or concurrent acute injury or disease that might compromise the participant's welfare according to investigator discretion, The participant is currently receiving, has received within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments at doses known to impair the wound healing
- include chronic systemic steroid intake of more than 10 mg prednisone (or equivalent) per day for more than 2 weeks, 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 one-month prior enrollment, in an area adjacent to the target wound,
- Mentally incompetent 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
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Nova Medical Research
Maimi, Florida, 33176
Niurka Montenegro, 786-715-9183, research@novamedicalcare.com
Sandor Romero
About this study
Official title: A Multicenter, Prospective, Randomized, Placebo and Non-Surgical Standard of Care (NSSOC) Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to NSSOC in Participants With Venous Leg Ulcers (VLU)
The objectives of this study are:
- To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to non-surgical standard of care (NSSOC)
- To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo control and compared to NSSOC.
Read the detailed description
45 eligible adult participants with VLU (with a surface area between 2 cm2 and 40 cm2 , and wound age between 4 weeks and 18 months), will be randomized. The participants will be treated with IMP (either EX-03 5% or placebo) in a double blinded manner or with NSSOC in unblinded manner.
Total duration of the study is up to 17 weeks:
Screening period (2 visits, 7 days apart),
Daily Visits Period (debridement with IMP/NSSOC): up to 8 daily site visits, (or less if a complete debridement occurred before 8 visits) within 14 days.
Weekly Visits Period (Wound management): the weekly period will include up to 13 visits in 12 weeks + optional wound closure confirmation (up to 2 weeks). Wound will be managed in a standardized manner.
- Conditions
- Venus Leg Ulcers
- Being tested
- EscharEx (EX-03), Placebo (Gel vehicle), Non-surgical standard of care (NSSOC)
- Keywords
- VLU, EscharEx, Debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Non-surgical standard of care (NSSOC)Other
Various dressings and Collagenase
| 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: EscharEx (EX-03) |
| Placebo | Placebo comparator | Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API.
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 Placebo powder, should be diluted with Water for Injection (WFI) prior usage Receives: Drug: Placebo (Gel vehicle) |
| Non-Surgical Standard of Care (NSSOC) | Other | Dressings and Collagenase Receives: Other: Non-surgical standard of care (NSSOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence (number of patients) of systemic and local adverse events (AEs) throughout the trial
The endpoint will assess number of patients, in each arm, with reported systemic and local AEs
Measured: Throughout the study (week 2- week 17)
Number of patients with Clinically significant changes in vital signs during the Daily Visits Period,
Number of patients with Clinically significant changes in vital signs
Measured: Weeks 2-3 (14 days)
Number of patients with Clinically significant changes in clinical laboratory parameters
Number of patients with Clinically significant changes in clinical laboratory parameters
Measured: Weeks 2-3 (14 days)
Time to complete wound closure
The outcome will assess time to reaching complete wound closure
Measured: Weeks 2-17
Incidence of complete wound closure
The outcome will assess number of patients reaching complete wound closure
Measured: 2-17 weeks
Secondary outcomes (2)
Incidence of complete debridement
the outcome will assess number of patients with complete debridement assessed clinically
Measured: Up to 8 applications (14 days)
Incidence of complete healthy viable granulation tissue
the outcome will assess number of patients with complete healthy viable granulation tissue on the treated wound, assessed clinically
Measured: Up to 8 applications (14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start10 Jan 2027 (estimated)
- Primary completion4 Nov 2028 (estimated)
- Study completion16 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venus Leg UlcersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690177
- Sponsor's protocol ID
- MW2023-11-18
- Other IDs
- 2026-526070-16
- Acronym
- H2H
- Status last verified
- Jun 2026
- First submitted
- 29 Oct 2024
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Placebo and Non-Surgical Standard of Care (NSSOC) Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to NSSOC in Participants With Venous Leg Ulcers (VLU)
- ClinicalTrials.gov ID
- NCT06690177
- Acronym / sponsor ID
- H2H / MW2023-11-18
- Conditions
- Venus Leg Ulcers
- Keywords
- VLU, EscharEx, Debridement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2027 (estimated)
- Primary completion
- 4 Nov 2028 (estimated)
- Study completion
- 16 Jan 2029 (estimated)
- First posted
- 15 Nov 2024 (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.
The objectives of this study are:
- To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to non-surgical standard of care (NSSOC)
- To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo control and compared to NSSOC.
Detailed description
45 eligible adult participants with VLU (with a surface area between 2 cm2 and 40 cm2 , and wound age between 4 weeks and 18 months), will be randomized. The participants will be treated with IMP (either EX-03 5% or placebo) in a double blinded manner or with NSSOC in unblinded manner.
Total duration of the study is up to 17 weeks:
Screening period (2 visits, 7 days apart),
Daily Visits Period (debridement with IMP/NSSOC): up to 8 daily site visits, (or less if a complete debridement occurred before 8 visits) within 14 days.
Weekly Visits Period (Wound management): the weekly period will include up to 13 visits in 12 weeks + optional wound closure confirmation (up to 2 weeks). Wound will be managed in a standardized manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EscharEx (EX-03) | Active comparator | Drug: 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 | Placebo comparator | Drug: Placebo (Gel vehicle)Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API. 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 Placebo powder, should be diluted with Water for Injection (WFI) prior usage |
| Non-Surgical Standard of Care (NSSOC) | Other | Other: Non-surgical standard of care (NSSOC)Dressings and Collagenase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women, older than 18 years of age,
- Participants with 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 18 months
- The adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and 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 2-40 cm2 (assessed by eKare inSightTM),
Key exclusion criteria (25 listed)
- Wound size decreased by >20% after 7 (+3/-1) days of the screening period,
- Participants with more than one leg ulcer8, 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,
- Signs of infection of the wound or peri-wound including purulent discharge, deep-tissue abscess, cellulitis, erysipelas, etc.,
- Severely damaged skin (e.g., abrasion, erosion, exfoliation) extending >2 cm around the wound's edge,
- Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis,
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 |
|---|---|---|
| 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 | EscharEx (EX-03) |
| 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 | Drug | Placebo |
| Non-surgical standard of care (NSSOC)Various dressings and Collagenase | Other | Non-Surgical Standard of Care (NSSOC) |
Primary outcome
Incidence (number of patients) of systemic and local adverse events (AEs) throughout the trial
Time frame: Throughout the study (week 2- week 17)
The endpoint will assess number of patients, in each arm, with reported systemic and local AEs
Number of patients with Clinically significant changes in vital signs during the Daily Visits Period,
Time frame: Weeks 2-3 (14 days)
Number of patients with Clinically significant changes in vital signs
Number of patients with Clinically significant changes in clinical laboratory parameters
Time frame: Weeks 2-3 (14 days)
Number of patients with Clinically significant changes in clinical laboratory parameters
Time to complete wound closure
Time frame: Weeks 2-17
The outcome will assess time to reaching complete wound closure
Incidence of complete wound closure
Time frame: 2-17 weeks
The outcome will assess number of patients reaching complete wound closure
2 secondary outcomes
Incidence of complete debridement
Time frame: Up to 8 applications (14 days)
Incidence of complete healthy viable granulation tissue
Time frame: Up to 8 applications (14 days)
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EscharEx (EX-03) in people with Venus Leg Ulcers, run by MediWound Ltd at 2 sites in 2 countries.
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 7 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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, MSc (+972 52 3527960, shellyv@mediwound.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (number of patients) of systemic and local adverse events (AEs) throughout the trial (time frame: Throughout the study (week 2- week 17)). The study lists 5 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 16 Oct 2026.