EscharEx for Venous Leg Ulcer
(VALUE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called EscharEx, a topical gel, to determine if it can clean and prepare venous leg ulcers (long-lasting leg wounds due to poor blood flow) more effectively than a placebo. Researchers aim to assess whether EscharEx is both safe and more effective at removing dead tissue from these wounds. Individuals with a venous leg ulcer lasting between 4 weeks and 1 year, with at least half of the wound covered by dead tissue, may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
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.
Is there any evidence suggesting that EscharEx is likely to be safe for humans?
Research has shown that EscharEx is as safe as other treatments like SANTYL. In previous studies, patients experienced good initial results using EscharEx for wound care. No major safety concerns arose, and the side effects were similar to those of other treatments. This indicates that patients generally tolerated EscharEx well. As this trial is in a later phase, extensive safety information is already available.12345
Why do researchers think this study treatment might be promising?
EscharEx is unique because it uses bromelain, a proteolytic enzyme derived from pineapple stems, as its active ingredient. Unlike standard treatments for venous leg ulcers, which often involve debridement through mechanical or surgical methods, EscharEx works enzymatically to break down dead tissue. This could potentially make the healing process faster and less painful. Researchers are excited about EscharEx because it offers a new approach that might enhance healing while minimizing discomfort for patients.
What evidence suggests that EscharEx might be an effective treatment for Venous Leg Ulcers?
Research shows that EscharEx, which participants in this trial may receive, holds promise for treating venous leg ulcers. Studies have found that EscharEx can quickly and effectively remove dead tissue from wounds, a process called debridement. Proper wound preparation is crucial for better healing and closure. Data from earlier trials indicated that EscharEx outperformed other treatments, suggesting it could significantly improve outcomes for patients with these ulcers. The treatment uses bromelain, an enzyme that breaks down dead tissue, potentially reducing pain and the risk of infection.26789
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Debridement
Participants receive daily debridement treatment with investigational medicinal product (IMP)
Wound Management
Weekly visits for wound management and optional wound closure confirmation
Wound Closure Durability
Monthly visits to assess wound closure durability for wounds closed during the weekly visits period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EscharEx
Find a Clinic Near You
Who Is Running the Clinical Trial?
MediWound Ltd
Lead Sponsor