EscharEx for Venous Leg Ulcers

(VLU Trial)

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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How does the treatment EscharEx differ from other treatments for venous leg ulcers?

EscharEx is unique because it is being tested as a treatment specifically for venous leg ulcers, whereas most existing treatments focus on compression therapy or other adjuvant therapies like pentoxifylline or hypochlorous acid. The novelty of EscharEx lies in its potential to offer a new approach to managing these ulcers, which are often challenging to treat effectively with current options. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessing the uncertainty of treatment outcomes in a previous systematic review of venous leg ulcer randomized controlled trials: Additional secondary analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Topical treatment of venous microangiopathy in patients with venous ulceration with Essaven gel--a placebo-controlled, randomized study. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Pentoxifylline for treatment of venous leg ulcers: a systematic review. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Changes in microcirculation in venous ulcers with Essaven gel--a pilot, cross-over, placebo-controlled, randomized study. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU). [2021]