EscharEx for Venous Leg Ulcers

(VLU Trial)

Not yet recruiting at 1 trial location

Overseen By Keren David- Zarbiv, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MediWound Ltd

Must not be taking: Steroids, Immunosuppressants, Chemotherapy, others

Disqualifiers: Infection, Cancer, Diabetes, Renal failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a new treatment called EscharEx for individuals with venous leg ulcers. The study compares EscharEx to a placebo (a non-active treatment) and a standard care treatment called Collagenase. Participants must have a venous leg ulcer present for at least four weeks but not longer than a year, with a significant amount of dead tissue covering the wound. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications known to affect wound healing, such as systemic steroids or immunosuppressive drugs, you may need to stop them before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that EscharEx, containing bromelain enzymes, is generally well-tolerated by patients. Earlier studies indicated that EscharEx had a safety record similar to SANTYL, a well-known treatment for similar conditions. People using EscharEx experienced side effects at about the same rate as those using standard treatments. While some side effects occurred, they were not more common than with other treatments. Overall, current evidence suggests that EscharEx is relatively safe for treating venous leg ulcers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for venous leg ulcers?

EscharEx is unique because it uses proteolytic enzymes, specifically enriched in bromelain, to help treat venous leg ulcers. Unlike standard treatments that often rely on topical antibiotics or dressings, EscharEx works by breaking down dead tissue to promote healing. This enzymatic action can potentially speed up the healing process, making it a promising option for those with stubborn ulcers. Researchers are excited about its ability to target the wound bed more directly, offering a different approach compared to traditional methods like collagenase.

What evidence suggests that this trial's treatments could be effective for venous leg ulcers?

Research has shown that EscharEx, a treatment under study in this trial, holds promise for treating venous leg ulcers. It aids in removing dead tissue and promotes the growth of healthy tissue. Studies indicate that it can reduce bacteria and the biofilm that often exacerbates wounds. The treatment uses bromelain, an enzyme from pineapples, to clean the wound without surgery. Early results suggest that EscharEx not only accelerates healing but also reduces pain and the risk of infection, making it a potentially valuable option for those with venous leg ulcers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for patients with venous leg ulcers. Specific eligibility criteria are not provided, but typically participants must have the condition being studied and meet certain health requirements.

Inclusion Criteria

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 procedure

I am over 18 years old.

Exclusion Criteria

Pregnant women or nursing mothers

Patients with skin disorders unrelated to the wound that are presented adjacent to the wound

A significant decrease in the arterial blood flow of the extremity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

2 visits (in-person)

Daily Visits Period - Debridement

Participants undergo debridement with investigational medicinal product (IMP) or placebo

2 weeks

Up to 8 daily site visits

Weekly Visits Period - Wound Management

Participants receive standardized wound management

10 weeks

Up to 11 visits (in-person)

Optional Wound Closure Confirmation

Optional confirmation of wound closure

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EscharEx
• Placebo

Trial Overview

The study tests EscharEx (EX-03), a new treatment for venous leg ulcers, against a placebo gel and Collagenase, which is the non-surgical standard care. The goal is to compare their safety and effectiveness in healing ulcers.

How Is the Trial Designed?

Group I: Collagenase Experimental Treatment 2 Interventions

Non-surgical standard of care treatment arm

Group II: EscharEx (EX-03) Active Control 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

MediWound Ltd

Lead Sponsor

Trials

14

Recruited

1,300+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06568627

A Double Blind Study Performed to Evaluate the Efficacy ...

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 ...

2.

ir.mediwound.com

ir.mediwound.com/news-releases/news-release-details/mediwound-announces-publication-phase-ii-escharexr-data

MediWound Announces Publication of Phase II EscharEx ...

The therapy has shown the ability to remove non-viable tissue, promote granulation tissue, and reduce bioburden and biofilm. A global Phase III ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06690177

NCT06690177 | Clinical Study to Evaluate the Safety and ...

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39763591/

Once daily Bromelain-based enzymatic debridement of ...

Previous studies have shown positive initial results with EscharEx® (EX-02 formulation), a Bromelain-based enzymatic debridement agent in ...

5.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/escharexs-pivotal-trial-for-venous-leg-ulcers/

Escharex's Pivotal Trial for Venous Leg Ulcers

EscharEx's potential to improve debridement and wound closure could significantly impact patient outcomes, reducing pain, infection risk, and ...

6.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/mediwound-trial-vlu/

MediWound begins Phase III trial for venous leg ulcers ...

MediWound has commenced a pivotal, multicentre Phase III VALUE trial to assess EscharEx, for treating venous leg ulcers (VLUs).