EscharEx for Venous Leg Ulcer

(VALUE Trial)

Recruiting at 4 trial locations

Overseen By Yael Katz-levy, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: MediWound Ltd

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

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 24

216 Participants Needed

Trial Summary

What is the purpose of this trial?

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 bed preparation of Venous Leg Ulcers (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 taking medications that affect wound healing, like steroids or immunosuppressive drugs, you may need to stop them before joining the trial.

Eligibility Criteria

This trial is for men and women over 18 with a Venous Leg Ulcer (VLU) that's been present for 4 weeks to 1 year. The ulcer must be between 2-25 cm², with at least half covered in non-viable tissue. Participants need an ultrasound showing venous insufficiency and must understand and agree to the study procedures.

Inclusion Criteria

My wound has been present for 4 weeks to 1 year.

My wound size is between 2 and 25 cm2.

I understand the study procedures and agree to follow them.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

2 visits (in-person, 7 days apart)

Debridement

Participants receive daily debridement treatment with investigational medicinal product (IMP)

2 weeks

Up to 8 daily site visits

Wound Management

Weekly visits for wound management and optional wound closure confirmation

10 weeks

Up to 11 visits (in-person)

Wound Closure Durability

Monthly visits to assess wound closure durability for wounds closed during the weekly visits period

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EscharEx

Trial Overview The trial tests EscharEx (EX-03), a topical treatment aimed at removing dead tissue from VLUs, against a placebo gel. It aims to see if EscharEx is more effective and safe in preparing the wound bed for healing compared to the placebo.

Participant Groups

Group I: 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 II: Placebo Placebo Group 1 Intervention

Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API. 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+