Not Yet RecruitingPhase 2

Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers

United States, Poland45 participantsStarted 2025-04-30

Plain-language summary

The main objective of this study is: To assess the safety of EscharEx (EX-03 5% formulation) compared to placebo control and compared to Collagenase (NSSOC) in patients with VLU.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men or women, older than 18 years of age,
. Patients 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 1 year,
. The necrotic/slough/fibrin non-viable tissue area is at least 50% of the wound area (assessed by clinical evaluation),
. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),
. Patient understands the nature of the procedure, is able to adhere to the protocol regimen, and provides a written informed consent prior to any study procedur

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence (number of patients) of target wound related AEs throughout the trial

Timeframe: Throughout the study (week 2- week 15)

Number of patients with Clinically significant changes in vital signs during the Daily Visits Period,

Timeframe: Weeks 2-3 (14 days)

Number of patients with Clinically significant changes in clinical laboratory parameters

Timeframe: Weeks 2-3 (14 days)

Time to complete wound closure

Timeframe: Weeks 2-15

Incidence of complete wound closure

Timeframe: 2-15 weeks

Trial details

NCT IDNCT06690177

SponsorMediWound Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Shelly Vander, MSc

+972 52 3527960 shellyv@mediwound.com

View on ClinicalTrials.gov More Venus Leg Ulcers trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men or women, older than 18 years of age,
. Patients 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 1 year,
. The necrotic/slough/fibrin non-viable tissue area is at least 50% of the wound area (assessed by clinical evaluation),
. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),
. Patient understands the nature of the procedure, is able to adhere to the protocol regimen, and provides a written informed consent prior to any study procedur

Exclusion criteria

What they're measuring

Incidence (number of patients) of target wound related AEs throughout the trial

Timeframe: Throughout the study (week 2- week 15)

Number of patients with Clinically significant changes in vital signs during the Daily Visits Period,

Timeframe: Weeks 2-3 (14 days)

Number of patients with Clinically significant changes in clinical laboratory parameters

Timeframe: Weeks 2-3 (14 days)

Time to complete wound closure

Timeframe: Weeks 2-15

Incidence of complete wound closure

Timeframe: 2-15 weeks